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Approved Concepts

Below are concepts approved at the most recent National Advisory Council on Aging (NACA) meetings. We have posted the approved concepts here to give interested researchers maximal lead time to plan projects. Please note that not all concepts will necessarily end up converting to a Notice of Funding Opportunity (NOFO), and some of the concepts listed below (particularly from older Council meetings) may have already been converted to NOFOs.

September 2023 Council

 

Centers on the Demography and Economics of Aging, including Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD), and Coordinating Center

The Centers on the Demography and Economics of Aging (D&E Centers) Program was initiated in 1994 to cultivate the field of demography and economics of aging via pilot projects, research networks, conferences and workshops, research resources and infrastructure, and disseminating findings. While recent NIA-supported activities are yielding important insights, sustained scientific investment and the continuation of the D&E program will be required to unravel the complex role of population-level processes on aging.

This concept proposes a continuation of the D&E Centers with the ongoing goal to seed innovative lines of research in the demography and economics of aging (and related interdisciplinary population-based social science areas) and add emphasis on activities that foster a more inclusive and population-representative group of scholars and institutions. This will be achieved via individual centers as well as a Coordinating Center that will serve as a bridge among centers, individual scholars, the NIA, and the research and policy communities.

Scientific/Research Contacts:

Amelia Karraker, Ph.D.
Division of Behavioral and Social Research
E-mail Amelia Karraker

Emerald Nguyen, Ph.D.
Division of Behavioral and Social Research
E-mail Emerald Nguyen

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Coordinating Center to Support the Consortium for Neuroscience AD/ADRD in Low- and Middle-income Countries

Alzheimer’s disease and Alzheimer’s disease-related dementias are a substantial global health issue and a great burden, particularly in low- and middle-income countries (LMICs). Although most people suffering from AD/ADRD live in LMICs, research on AD/ADRD in these regions is limited and under-resourced. Access to AD/ADRD research funding continues to be a concern for scientists in LMICs. Longer term funding programs that support independent and innovative investigator-initiated research for LMIC scientists will be of great importance for the sustainability of research in those regions. 

This concept aims to support the development of a Coordination Center (CC) for a companion concept establishing a LMIC Consortium program, as well as a program focused on supporting small research grants for junior faculty investigators in LMICs. The CC will serve as an administrative and coordinating center for the consortium; define a strategy for consortium data collection and analyses; develop an online portal for consortium resources consistent with Findable, Accessible Interoperable, and Re-Usable (FAIR) guiding principles; and coordinate consortium-led analyses and outreach efforts. 

Scientific/Research Contacts:

Maryam Ghaleh, Ph.D.
Division of Neuroscience
Email Maryam Ghaleh

Damali Martin, Ph.D., M.P.H.
Division of Neuroscience
Email Damali Martin

Dallas Anderson, Ph.D., M.P.H.
Division of Neuroscience
Email Dallas Anderson

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Consortium for Neuroscience AD/ADRD in Low- and Middle-income Countries

Access to Alzheimer’s disease and related dementias research funding continues to be a concern for scientists in low- and middle-income countries. Most LMIC scientists obtain funding support through research collaborations with partners from high-income countries (HICs) within Europe or North America, where the funding environment is substantially better. However, this may diminish the ability of LMIC scientists to lead and perform sustainable research, while building collaborative research networks relevant to them. Longer-term funding programs that support independent and innovative investigator-initiated research for LMIC scientists will be of great importance for the sustainability of research in those regions.

This concept aims to support experienced LMIC scientists to perform innovative and sustainable AD/ADRD neuroscience research within their LMIC environment. This would enhance the ability of investigators to compete independently for sustained funding in AD/ADRD research in future funding opportunities. This concept proposes cooperative agreements with the LMIC institution. LMIC investigators would be required to collaborate with U.S. investigators using the multiple principal investigators approach, however they may also collaborate with LMIC investigators in another country. Research proposed is investigator-initiated and the applicants must demonstrate relevance to their LMIC. In addition, applicants will be required to demonstrate how their proposed research can inform preventative or therapeutic strategies for the United States and globally.

Scientific/Research Contacts:

Maryam Ghaleh, Ph.D.
Division of Neuroscience
Email Maryam Ghaleh

Damali Martin, Ph.D., M.P.H.
Division of Neuroscience
Email Damali Martin

Dallas Anderson, Ph.D., M.P.H.
Division of Neuroscience
Email Dallas Anderson

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Consortium for Palliative Care Research Across the Lifespan

Palliative care is active holistic interdisciplinary care focused on improving quality of life for persons with serious illness across the lifespan and their families and caregivers. NIA convened a trans-NIH working group to identify research needs and explore options for palliative care research opportunities. Among these discussions is support for a coordinated palliative care research infrastructure inclusive of the lifespan and a range of serious illnesses that strengthens NIH investment in palliative care research and the scientific workforce. This research infrastructure encompasses Alzheimer’s disease and Alzheimer’s disease-related dementias, cancer, and many other serious illnesses and populations relevant to the partnering institutes, centers, and offices (ICOs). 

This concept aims to establish a Consortium for Palliative Care Research Across the Lifespan that expands and intensifies palliative care research across NIH. The proposed consortium will be supported through a cooperative agreement that allows for multiple cores, involvement from project scientists across NIH, and encourages interaction with other NIA- and NIH-supported networks and centers. The overall consortium goals include creating new scientific knowledge, in part through supporting pilot and exploratory studies; fostering development of early- and mid-career investigators; serving as a national platform to provide research resources and facilitate high-quality research; engaging health care systems and community-based organizations as research partners and settings; and disseminating research findings, best practices, data, and other impactful resources to the research and clinical communities. An important focus will be research that addresses disparities in access, quality, and use of palliative care services for underserved populations.

Scientific/Research Contacts:

Basil Eldadah, M.D., Ph.D.
Division of Geriatrics and Clinical Gerontology

Alexis Bakos, Ph.D., M.P.H., R.N.
Division of Geriatrics and Clinical Gerontology

Elena Fazio, Ph.D.
Division of Behavioral and Social Research

Chandra Keller, Ed.D., M.P.H., M.P.P.
Division of Behavioral and Social Research

Email: NIAPalliativeCareResearch@nih.gov

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Deriving Common Data Elements from Real-World Data for Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias

Real-World Data (RWD) originate from everyday health care interactions, making it a crucial resource for various medical research and applications. Some examples of RWD include electronic health records, claims and billing data, registry data, and data collected from digital health technologies. But RWD relevant to people living with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) are often not aligned or harmonized. Common Data Elements (CDEs) are defined fields and structures that enable interoperability among data systems and have the potential to harmonize RWD to assist AD/ADRD research. Reducing the efforts required for data harmonization in using RWD for analysis will enable researchers to utilize RWD faster and more efficiently.

To facilitate the use of RWD for AD/ADRD research, this concept proposes a cooperative agreement in which researchers will standardize vocabulary and identify, develop, and test longitudinal CDEs by using electronic health record data and the Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse data. These CDEs will encompass various categories, including but not limited to 1) patient and caregiver information, 2) disease characterization, including multiple chronic conditions, 3) health assessment, 4) biomarkers and genomics, 5) treatment, 6) patient and caregiver outcomes, and 7) non-health (e.g., financial, education, employment status, living arrangement, food, housing, or transportation security) data. Further, this initiative aims to help identify specific risk factors that will aid earlier diagnosis and treatment of mild cognitive impairment and dementia. The cooperative agreement would require collaboration with the RFA-AG-24-009 awardee.

Scientific/Research Contacts:

Janey Hsiao, Ph.D.
Division of Behavioral and Social Research
Email Janey Hsiao

Nadezda Radoja, Ph.D.
Division of Neuroscience
Email Nadezda Radoja

Marcel Salive, M.D., M.P.H.
Division of Geriatrics and Clinical Gerontology
Email Marcel Salive

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Exploring Proteogenomic Approaches to Unravel the Mechanisms of Mis-folded Protein Accumulation in Tauopathies 

The accumulation of misprocessed and misfolded proteins is a defining characteristic of many neurodegenerative diseases, including Alzheimer's disease. However, conventional “omics” approaches are typically not capable of detecting these types of proteins and better methods are needed to understand the underlying mechanisms of protein processing in relation to the early pathogenesis of tauopathies in AD. 

This concept will provide a proof-of-principal for a novel strategy to identify atypical proteins in Tau diseases using proteogenomics, an integrated approach that combines proteomics and genomics data to identify coding and non-coding regions on the genome. This concept aims not only to identify and confirm changes in proteins, but also to apply a robust approach to biological inference to better understand the proteomic data. This may involve cutting-edge approaches, such as RNAseq, mass spectrometry-based deep proteomic analysis, and transgenic mouse models, to investigate the alteration of protein homeostasis in response to the accumulation of various mis-metabolized proteins that contribute to brain aging and AD. 

Scientific/Research Contact:

Austin Yang, Ph.D.
Division of Neuroscience
Email Austin Yang

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Limited Competition: Renewal of, and Revisions to, the Alzheimer's Disease Genetics Consortium

The Alzheimer’s Disease Sequencing Project (ADSP) aims to sequence and analyze the genomes of well-characterized individuals with the aim of identifying risk and protective genetic variants associated with Alzheimer’s disease and Alzheimer’s disease-related dementias. In addition, the ADSP conducts and facilitates analysis of sequence data to extend previous discoveries that may ultimately result in new directions for AD therapeutics. More recently, the ADSP launched the diversity and phenotype harmonization and functional genomics and artificial intelligence/machine learning (AI/ML) initiatives. As the ADSP enters its second decade it's critical to ensure that the ADSP is more representative of the diversity of the United States and the world and capable of identifying personalized AD/ADRD solutions. Searching for risk variants in diverse populations may also lead to the discovery of new AD variants and mechanisms that could be broadly beneficial.

This concept intends to support the second renewal of the Alzheimer’s Disease Genetics Consortium (ADGC), part of the ADSP. The ADGC will serve as the coordinating center for the ADSP consortium. It will facilitate collaboration and communication across the projects funded under the ADSP umbrella and with other NIA funded consortia. The ADGC will oversee and coordinate consortium-generated methodology, protocols, and tools; development and maintenance of a portal for consortium resources; use of data for AI/ML and other data science initiatives; data sharing and access; support of pilot studies and consortium-led analyses and data collection; collaboration across the ADSP consortia and with the broader AD genetics community; and dissemination of ADSP resources to the larger research community.

Scientific/Research Contacts:

Alison Yao, Ph.D.
Division of Neuroscience
Email Alison Yao

Damali Martin, Ph.D., M.P.H.
Division of Neuroscience
Email Damali Martin

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Multi-Scale Models Bridging Levels of Analysis in Aging and AD/ADRD

The rapidly developing, multidisciplinary field of computational science — including mathematical and computer modeling, image analysis, artificial intelligence, and machine learning — is generating new ways to approach aging and Alzheimer’s and related dementias research. Multiscale approaches are capable of the next level of integration across computational models to allow for multidisciplinary and multifunction modeling that dynamically interact and offer insight into biology, function, and real-world complexity linked with aging and dementia. 

This concept encourages the development of a multi-scale computational framework to model dynamic changes associated with both aging and Alzheimer's and related dementias. The proposed framework should bridge at least two levels of analysis on the spatial scale (molecules, cells, tissues, organisms, behavior) or temporal scale (spanning from milliseconds to generations). It should also address a targeted research question through a targeted computational model to provide new insights into the function or dynamics of biology, disease, or a behavioral system. The framework should include at least one aim centered on hypothesis testing and model validation respectively. Topics may include, but are not limited to, aging clocks, hallmarks of aging, oscillations in energetics and/or metabolism of aging, age-related changes in synaptic activity across scales, image-based analysis of aging function, biology, and disease, dynamic patterns of interventions to promote healthy aging (e.g., intermittent fasting).

Scientific/Research Contact:

Amanda DiBattista, Ph.D.
Division of Neuroscience
Email Amanda DiBattista

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Nathan Shock Centers of Excellence in the Basic Biology of Aging

Note: This is a companion concept to the "Nathan Shock Centers of Excellence in the Basic Biology of Aging Coordinating Center" concept

This concept aims to provide support, through open competition, for the Nathan Shock Centers (NSCs). These center grants will provide funding for leadership, training, and research activities that will increase and disseminate scientific knowledge in research areas related to the biology of aging. Established in 1995, there are currently eight funded NSCs.

The NSC are national resources in the basic biology of aging and geroscience, reaching beyond their own proposed institutions. The proposed notice of funding opportunity would enhance, sustain, and support basic research on the molecular and cellular mechanisms of aging, and may include support for clinical research (research including humans, but not clinical trials). Required activities include:

  • Provide intellectual leadership and innovation;
  • Facilitate and develop novel multidisciplinary and interdisciplinary research strategies through specific research service cores;
  • Stimulate incorporation of emerging technologies, methods, and scientific advances into research projects;
  • Provide research education, mentorship, and career development;
  • Stimulate translation between basic and clinical research;
  • Collaborate with other NSCs on multi-center research education, mentorship, and outreach programs;
  • Interface with other NIA-funded centers through the Research Centers Collaborative Network;
  • Leverage institutional resources, including other NIH-supported programs and centers, to achieve NSC aims; and
  • Serve as a source of mentorship and collaboration to other investigators regarding technology, methodology, analysis, or other expertise.

In addition to required activities, new topic areas of research may include, but are not limited to, newly recognized drivers of aging, metrics of aging, lifecourse approaches to aging biology, species-differences and similarities in aging, and medicinal chemistry for development of gero-therapeutic/protective pharmacological interventions. Education and outreach topics may include, but are not limited to mini-sabbaticals for mid-career and senior investigators, community engagement, courses in biology of aging, and open access webinars.

Scientific/Research Contact:

Christy Carter, Ph.D.
Division of Aging Biology
Email Christy Carter

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Nathan Shock Centers of Excellence in the Basic Biology of Aging Coordinating Center

Note: This is a companion concept to the “Nathan Shock Centers of Excellence in the Basic Biology of Aging” concept

The Nathan Shock Centers of Excellence in the Basic Biology of Aging Coordinating Center (NSC3) was established in 2017 as the focal point for coordinating Nathan Shock Centers (NSCs). This concept aims to develop and maintain the NSC3. Major activities of the NSC3 will including improving national visibility of the NSCs; enhancing collaboration and coordination among NSC and other centers for aging research; expanding and tracking training activities; facilitating the sharing of resources; and strategic planning with NIA and NSCs.

Scientific/Research Contact:

Christy Carter, Ph.D.
Division of Aging Biology
Email Christy Carter

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Open Measurement Coordinating Network for Non-Pharmacological AD/ADRD Primary Prevention Trials

Recent clinical trials and observational studies suggest that targeting disease and modifiable risk factors in midlife or earlier may help prevent or delay significant cognitive and functional impairment in Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD). However, only 15% of AD/ADRD research has participants with mean age < 60 and ~3% < 50 years. In addition to involving younger, population-representative clinical trial participants, constructing a stronger evidence base for AD/ADRD prevention requires the use of valid, standardized measures across trials.

This concept aims to create a shared, open measurement coordinating network to support non-pharmacological primary prevention AD/ADRD trials. The network will serve as a centralized hub for developing, validating, standardizing, and disseminating measures and methods for AD/ADRD primary prevention trials. It will incorporate measures and methods across neuropsychological, biomarker, and functional domains to meet the goal of primary prevention of AD/ADRD centered around brain health equity. Measures and methods of interest will test outcomes and mechanisms of action in settings customized for individuals with different needs and linked to real-world function. The network will work with other NIA-funded programs to ensure interoperability, promote diversity, equity, and inclusion, and ensure the methods and resources are widely adopted by researchers and stakeholders.

Scientific/Research Contact:

Luke Stoeckel, Ph.D.
Division of Behavioral and Social Research
Email Luke Stoeckel

Kristina McLinden, Ph.D.
Division of Neuroscience
Email Kristina McLinden

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Quantitative Systems Pharmacology Approach to Develop Predictive Models of Differential Responsiveness to Treatment for AD/ADRD

One of the biggest challenges in therapy development for AD/ADRD is identifying patients that are most likely to respond to treatment due to the clinical, pathologic and molecular heterogeneity of the disease. Many promising interventions for AD/ADRD (drug trials or non-pharmacologic interventions such as diet and exercise) have shown limited utility, or an overall negative result, due to differences in responsiveness to treatment among the trial participants. NIA has been developing new programs and capabilities for data-driven and predictive drug development and embedding open-science/open-source principles from discovery research to clinical trials. Of particular note is the implementation of requirements for sharing data and biosamples from all NIA supported clinical trials including pivotal/registration trials.

Quantitative Systems Pharmacology (QSP) is an approach to translational medicine that combines computational and experimental methods to provide an integrated, systems-level approach to determining mechanisms of action of new and existing drugs in preclinical/animal models and in patients. This concept proposes a new funding initiative that will support the application of quantitative systems pharmacology (QSP) approach that integrates rich molecular (multi-omics) data generated on biosamples from legacy trials as well as ongoing AD/ADRD clinical trials (drug trials as well as non-pharmacologic interventions) with patient-level, clinical/phenotypic data to build predictive models of AD/ADRD and discover molecular determinants of responsiveness to treatment. This funding initiative will also support the application of QSP modeling for back translation of failed AD/ADRD therapeutics to understand the molecular drivers of failure in the clinic by providing access to clinical trials data and biosamples, and by evaluating failed therapeutics in a rigorous preclinical efficacy testing pipeline. 

This initiative will operate under open-science principles and will encourage academic-industry collaborations. 

Scientific/Research Contacts:

Suzana Petanceska, Ph.D.
Division of Neuroscience
Email Suzana Petanceska

Nandini Arunkumar, Ph.D.
Division of Neuroscience
Email Nandini Arunkumar

Lorenzo Refolo, Ph.D.
Division of Neuroscience
Email Lorenzo Refolo

Laurie Ryan, Ph.D.
Division of Neuroscience
Email Laurie Ryan

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Re-issue: Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials

The Alzheimer’s Clinical Trials Consortium (ACTC) is an NIA-supported clinical trials infrastructure and network of 38 member sites dedicated to Alzheimer’s and related dementias. The mission of ACTC is to provide an optimal infrastructure, utilizing centralized resources and shared expertise, to accelerate the development of effective interventions for ADRD.

This concept proposes a re-issue of the ACTC clinical trials NOFO (PAR-20-309). This concept seeks to expand the pipeline of interventions being tested through the ACTC by inviting research grant applications that provide clinical testing of promising pharmacological and non-pharmacological interventions targeting cognitive and neuropsychiatric changes associated with age-related cognitive decline and Alzheimer’s and related dementias across the spectrum of disease stages.

Scientific/Research Contacts:

Kristina McLinden, Ph.D.
Division of Neuroscience
Email Kristina McLinden

Laurie Ryan, Ph.D.
Division of Neuroscience
Email Laurie Ryan

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Re-issue: Early and Late Stage Clinical Trials for the Spectrum of Alzheimer’s Disease/Alzheimer’s Related Dementias and Age-Related Cognitive Decline

Recent biomedical advances and approved drugs for Alzheimer’s disease and Alzheimer’s disease-related dementias represent important progress in the ongoing fight to effectively treat these diseases. Nevertheless, additional efforts remain necessary to tackle the devastating effects of AD/ADRD. To this end, efficient mechanisms to fund clinical trials pursuing diverse therapeutic targets and approaches to prevent, delay, and treat AD/ADRD are critical. The early and late-stage clinical trials notice of funding opportunities have been mainstays and the primary avenue for NIA-supported clinical trials focusing on AD/ADRD and age-related cognitive decline.

This concept proposes a re-issue of the Early and Late Stage Clinical Trials for the Spectrum of Alzheimer’s Disease/Alzheimer’s Related Dementias and Age-Related Cognitive Decline funding opportunity. The proposed funding opportunity would invite applications that provide clinical testing (Phase I to III) of promising pharmacological and non-pharmacological interventions for cognitive and neuropsychiatric symptoms in individuals with age-related cognitive decline and in individuals with AD/ADRD across the spectrum from pre-symptomatic to more severe stages of disease. In addition, it would invite applications for studies focused on enhancing trial design and methods. Finally, ensuring diversity of participants within trial cohorts, and timely, broad access to trial data and associated biosamples are key components of this concept.

Scientific/Research Contacts:

Laurie Ryan, Ph.D.
Division of Neuroscience
Email Laurie Ryan

Akanni Clarke, Ph.D.
Division of Neuroscience
Email Akanni Clarke

Kristina McLinden, Ph.D.
Division of Neuroscience
Email Kristina McLinden

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Renewal of Aging Research Dissertation Awards to Increase Diversity

NIA established the R36 Aging Research Dissertation Awards to Promote Diversity in 2005 with a goal of promoting diversity in the pool of doctoral-level candidates engaged in research and practice on aging and aging-related health conditions. R36 applicants must be Ph.D. students committed to careers in aging research, who need only 1-2 years of funding support in order to complete their Ph.D. and progress to the next phase of their aging research career. Institutions are encouraged to identify candidates from groups underrepresented in the biomedical sciences. Since its founding, the program has funded 78 awards across all four of NIA’s scientific divisions, with 11 awards currently active. These have shown scientific success, with awardees citing R36 support in more than 100 publications.

Strong financial support for predoctoral students is essential, especially for students from underrepresented groups, who are less likely to have family financial support, and more likely to have caregiving roles. The Aging Research Dissertation Award supports diverse doctoral students with salary and research funding at a critical period in their training: the final 1-2 years of their Ph.D., when other funding sources such as National Research Service Award or institutional support often run out. In the next phase of the program, NIA will continue to consider how best to support this population.

Scientific/Research Contacts:

Jamie Lahvic, Ph.D.
Office of Strategic Extramural Programs
Email Jamie Lahvic

Joshua Hooks, Ph.D.
Office of Strategic Extramural Programs
Email Joshua Hooks

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Renewal of Institutional Training Programs to Advance Translational Research on Alzheimer's Disease and AD-related Dementias

Investing in the development of a new translational and data science workforce is an overarching theme from past Alzheimer’s Disease Research Summits. In addition, NIA’s growing investment in open science, precision medicine research, and translational research infrastructure is delivering a wealth of data, research tools, and resources. Currently, application of data science to drug discovery for Alzheimer’s and related dementias research remains a critical need in this area.

This concept aims to promote the development of a diverse, interdisciplinary workforce needed to conduct translational research on Alzheimer’s and related dementias from target discovery through clinical development. This concept proposes to renew the T32 notice of funding opportunity to support institutional training programs for predoctoral and postdoctoral researchers with diverse educational backgrounds (i.e., basic biology, translational and clinical research, data science and behavioral research). These interdisciplinary training programs will emphasize the development and application of skills in data science, drug discovery, and clinical research to various aspects of Alzheimer’s and related dementias research.

Scientific/Research Contacts:

Yuan Luo, Ph.D.
Division of Neuroscience
Email Yuan Luo

Shreaya Chakroborty, Ph.D.
Division of Neuroscience
Email Shreaya Chakroborty

Laura Major, Ph.D.
Division of Behavioral and Social Research
Email Laura Major

Maria Carranza, Ph.D.
Office of Strategic Extramural Programs
Email Maria Carranza

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Renewal of NIA MSTEM: Advancing Diversity in Aging Research (ADAR) Through Undergraduate Education

Attracting and training the workforce necessary for rigorous research on aging, including investigators from diverse backgrounds, is a key area of emphasis in NIA’s strategy for addressing health disparities and eliminating health inequities among older adults. NIA seeks to support the development of creative and innovative research education programs to increase participation in aging research among individuals from historically underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.

This concept proposes a renewal of the NIA MSTEM: Advancing Diversity in Aging Research Through Undergraduate Education notice of funding opportunity. This concept renewal will support creative research education programs with a primary focus on hands-on research experiences for undergraduate students. NIA seeks applications for academic year or summer programs and activities that offer:

  • Structured research experiences
  • Tailored learning opportunities
  • An emphasis on explaining the relevance of aging and the science of aging to students' lives, and
  • Opportunities to engage and develop a cadre of graduates who will help to diversify the aging science workforce on aging, enrich the questions asked, and expand the scope of evidence-based interventions.

Programs should be planned that allow for sustained multi-year involvement from undergraduates.

Scientific/Research Contact:
Maria Carranza, Ph.D.
Office of Strategic Extramural Programs
Email Maria Carranza

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Renewal of Summer Research Training in Aging for Medical Students

The Ruth L. Kirschstein National Research Service Award (NRSA) program has been one of the NIH’s primary means of supporting predoctoral and postdoctoral research training programs since 1974. The Summer Research Training in Aging for Medical Students is an NIA-specific NRSA short-term research training program that is intended to: 1) encourage medical students, early in their training, to consider pursuing either a basic science or health-services or clinical-research career in the areas of research that are important to the NIA; and 2) increase the pool of physician scientists engaged in biomedical, clinical or health-services research in those areas necessary to continue NIA's mission.

This concept seeks the renewal of the Summer Research Training in Aging for Medical Students. The programs funded through this funding opportunity are intended to provide short-term support for the training experiences of medical student trainees under the supervision of experienced researchers. Through a combination of classroom, workshop, and research experiences, this program is intended to give medical trainees a working knowledge of various potential career directions that makes strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.

Scientific/Research Contacts:

Maria Carranza, Ph.D.
Office of Strategic Extramural Programs
Email Maria Carranza

Shoshana Kahana, Ph.D.
Office of Strategic Extramural Programs
Email Shoshana Kahana

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Research Collaboration Network in Structural Racism Measurement and Modeling

While the field of public health has measured structural racism, there is ample opportunity to integrate approaches from fields not traditionally included in the health sciences (e.g., the humanities, sociology, education, political science) to collaborate with public health scientists to better understand how structural racism may influence health disparities in aging and Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD). The key to improving measurement in structural racism is to support a variety of science development activities (e.g., intensive summer institutes, series of workshops and related network activities, advanced seminars on methodology, annual conferences, or short-term residential opportunities) and build interdisciplinary frameworks to assess existing measures/methods and develop new measures/methods.

This concept aims to build a collaborative, interdisciplinary network of scholars to identify new measures, develop conceptual frameworks, and catalyze new research. The network will also conduct pilot studies to test and demonstrate the utility of studying the impact of existing and new measures of structural racism in aging-relevant research. 

The following activities are planned:

  1. Expansion of structural racism measures and methods through input from the broader research community and development of a publicly available data repository for use by researchers, community members, and policy makers through a data portal
  2. Support of activities that bring together scholars in the behavioral/sciences, humanities, education, political science, and the public health sciences to improve measurement and methods for the study of­ structural racism
  3. Collaboration, outreach and dissemination to the community for input on the operationalization of structural racism and formation of a community advisory board
  4. Engagement with national and international scientific organizations to promote further advances in measurement and methods of structural racism
  5. Pilot projects on measurement and methods of structural racism, incorporating interdisciplinary approaches from the behavioral/social sciences, humanities, education, and political science with the public health sciences
  6. Develop and foster an extended Structural Racism Measurement and Methods Research Network connecting the broader field through a flexible range of activities that will advance an interdisciplinary research agenda on measurement and methods of structural racism from the humanities, sociology, education, political science, and public health sciences
  7. Collaborate with NIA Centers and other research networks on measurement and methods for the study of structural racism
  8. Serve as a central resource for the organization of meetings and other educational activities, such as intensive summer institutes, series of workshops and related network activities, advanced seminars on methodology, annual conferences, or short-term residential opportunities

Scientific/Research Contact:

Frank Bandiera, Ph.D., M.P.H.
Division of Behavioral and Social Research
Email Frank Bandiera

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Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults

Up to 40% of older adults in the United States report living with chronic pain, which is associated with impaired mobility, activity avoidance, depression, anxiety, sleep impairment, substance use, and social isolation. Treatment of pain in later life is complex and often inadequate. Pain relief drugs commonly prescribed for younger patients have a greater risk of adverse effects in older adults. Psychedelic-assisted therapy (PAT) is an emerging treatment strategy that holds promise for a variety of important clinical conditions, including chronic pain. Previous and ongoing trials of PAT have included limited numbers of older adults. Although these older participants have tolerated treatment well without significant adverse effects to date, more focused safety and efficacy studies are needed in older adults.

This concept aims to develop a strong evidence base for safety and preliminary efficacy of PAT for chronic pain relief in older adults. It will use a two-phased approach to collect safety and early efficacy data in defined groups of older adults. Phase 1 studies will involve safety studies in healthy older adult volunteers across a broad age range. If milestones are achieved to warrant transition, phase 2 studies will include expanded safety and preliminary efficacy studies in older adults with chronic pain conditions such as cancer, musculoskeletal pain, peripheral neuropathy, post-herpetic neuralgia, and recurring headaches. This concept will support a single multi-center consortium that will plan, conduct, and evaluate multiple PAT intervention studies. Emphasis will be placed in both phases of this initiative on recruitment of specific age strata across the full range of older ages, as well as on health disparities and equitable access to care. Awardees should incorporate study design considerations that can inform implementation in future practice settings.

Scientific/Research Contact:

NIA Psychedelic Research
niapsychedelicresearch@nih.gov

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Small Business Transition Grant for New Entrepreneurs

While scientists, engineers, and health professionals offer valuable technical skillsets and practical insights required for technology development, their academic training and professional experience often do not prepare them for successfully navigating the entrepreneurial process, developing and commercializing products, or operating a small business. As a result, new scientist-entrepreneurs, particularly those underrepresented in biomedical research, face acute challenges in securing the mentorship and resources needed to fully contribute to the biomedical entrepreneurial enterprise. Building on the success and learnings from NIA Research and Entrepreneurial Development Immersion (REDI) initiative and the NCI Small Business Transition Grant, a successor program with greater coordination and scale is needed to further NIH’s success in developing a diverse pool of trainees with broad skillsets ready and able to succeed in the wide variety of roles critical to the overall R&D ecosystem.

This proposed concept leverages the SBIR/STTR mechanism to facilitate the career development and transition of scientists with an interest in entrepreneurship by simultaneously supporting their entrepreneurial development and the conduct of translational focused research under their direction. This concept specifically aims to support scientists new to entrepreneurship with a demonstrable need for entrepreneurial training and mentorship. The proposed funding opportunity would provide small businesses the opportunity to increase their scientific staff by supporting the hiring, salaries, mentorship, and training of transitioning scientist-entrepreneurs as Program Directors/Principal Investigators (PDs/PIs) overseeing the supported research project. In addition, each small business will ensure robust entrepreneurial training and structured mentoring to support the career growth and development of the PD/PI. 

Scientific/Research Contacts:

Joshua Hooks, Ph.D.
Office of Strategic Extramural Programs
Email Joshua Hooks

Todd Haim, Ph.D.
Office of Strategic Extramural Programs
Email Todd Haim

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Small Research Grant Program for the Next Generation of Researchers in Low- and Middle-income countries (LMICs) for Aging and Alzheimer's Disease (AD) and AD-related Dementia Research (ADRD)

Diversity in AD/ADRD research participants and global research efforts are crucial in ensuring research findings are generalizable, as well as in advancing our understanding of risk and preventive factors for AD/ADRD in different populations. However, in many institutions in low- and middle-income countries  there is very little support for junior faculty investigators to launch an independent research career. While most NIH career development awards utilize the K award mechanism, junior faculty scientists in LMICs have faced challenges (e.g., balancing research time with clinical responsibilities) in setting aside 75% protected time to perform research as required by K awards.

This concept proposes to use Small Research Awards to support junior faculty investigators involved in AD/ADRD and aging research in LMICs; advance AD/ADRD or aging research being conducted in LMICs; support AD/ADRD or aging research career development among LMIC investigators; and build local capacity for AD/ADRD and aging research in LMICs. This award mechanism may provide LMIC junior faculty investigators greater flexibility in determining their level of effort, while still accomplishing research milestones, advancing careers focused on AD/ADRD or aging relevant research, and allowing for the generation of data in preparation for later stage independent funding. In addition, this award may allow these investigators to hire the scientific staff needed to support their research.

Scientific/Research Contacts:

Maryam Ghaleh, Ph.D.
Division of Neuroscience
Email Maryam Ghaleh

Damali Martin, Ph.D., M.P.H.
Division of Neuroscience
Email Damali Martin

Minki Chatterji, Ph.D.
Division of Behavioral and Social Research
Email Minki Chatterji

Basil Eldadah, M.D., Ph.D.
Division of Geriatrics and Clinical Gerontology
Email Basil Eldadah

Stacy Carrington-Lawrence, Ph.D.
Division of Aging Biology
Email Stacy Carrington-Lawrence

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Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimer’s Disease and Related Dementias

Drug repurposing has several advantages over the development of new drugs including, shorter development times, lesser cost of development and higher success rates. In 2017, NIA established a cross-disciplinary program bringing translational bioinformatics approaches to drug repurposing and combination therapy development for Alzheimer’s disease and Alzheimer’s disease-related dementias. The program has brought investigators with deep expertise in data science and multiscale modeling working on other chronic disorders into AD/ADRD research. Cutting edge computational methods, including artificial intelligence and machine learning approaches, have facilitated the identification of hundreds of potentially repurposable drugs. However, there remains a need for rigorous and reproducible experimental and functional data to validate the efficacy of these putative drug candidates for potential drug repurposing and combination therapy development for AD.

This concept aims to support a renewal of the funding initiative: Translational Bioinformatics Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimer’s Disease. The new iteration of the program will build on NIA’s investment in data-driven approaches to AD drug repurposing and combination therapy development. This concept is envisioned to expand the current efforts and focus on prioritization of drug candidates and rigorous and reproducible proof-of-concept efficacy studies in cell-based models, animal models, and mechanistic studies in humans. Computational approaches will be supported only when proposed in conjunction with experimental studies to test the efficacy of prioritized candidate drugs/drug combinations. A key aspect of this initiative will be open science practices and full transparency of reporting of data, methods and results.

Scientific/Research Contact:

Nandini Arunkumar, Ph.D.
Division of Neuroscience
Email Nandini Arunkumar

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May 2023 Council

Approved research and development contract in this round:

Technology to Facilitate Characterization of the Exposome in Under-Resourced Populations for AD/ADRD Studies

The exposome refers to the comprehensive set of exposures in people’s physical, chemical, social, psychological, and economic environments. In order to fully characterize the exposome, it is necessary to collect both environmental and biological samples. However, while under-resourced populations often carry the highest burden of age-related diseases, they are often precluded from research studies due to difficulties in collecting the necessary environmental and biological samples. New technologies that enable self-sampling and point-of-exposure sampling of the exposome may help lower barriers to data collection among these populations and advance NIA’s understanding of the cause of complex conditions such as Alzheimer’s disease and related dementias (AD/ADRD).

This concept aims to facilitate the development of technologies that enable remote or self-sampling of exposome measures that can be combined with remote point-of-exposure measures in long-term population-based studies. These technologies will provide a powerful lens to characterize the exposome by validating measures and reducing costs to increase study inclusion of under-resourced populations.

Contracting Officer:

Karen Mahon
Office of Acquisitions, NIDA/NIA
Email Karen Mahon

Scientific/Research Contact:

Richard Kwok, Ph.D.
Division of Neuroscience, NIA
Email Richard Kwok

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January 2023 Council

Approved research concepts in this round:

Approved contract concepts in this round:

Analytical and Clinical Validation of Biomarkers for AD/ADRD

A biomarker is any measurable characteristic that can serve as an indicator of normal or pathogenic biological processes, or responses to exposures or interventions. Biomarkers can encompass a wide range of modalities, including measurement of analytes in body fluids, genetic, imaging, physiological and behavior or functional changes. Biomarkers are used in basic, translational, and clinical research and in clinical settings to inform patient care (disease related biomarkers) and/or facilitate medical product development decisions (product related biomarkers). NIA has supported multiple projects aimed at the discovery of novel biomarkers for Alzheimer’s Disease and related dementias (AD/ADRD), and many candidates have been identified. However, few are progressing from discovery to analytical and clinical validation, and their clinical and scientific utility remain indeterminate. A particularly pressing issue is the co-occurrence of ADs and ADRDs, since autopsies show that neuropathological comorbidities are common in the brains of people with dementia. Studies are also needed to determine longitudinal trajectories of biomarkers along the course of disease, or treatment, as well as generalizability of given biomarkers/biomarker signatures to diverse population.

The FDA has promulgated a useful framework and guidance for developing and validating biomarkers, in general. Acceptance or qualification of new biomarkers by the FDA requires both Analytical Validation and Clinical Validation within a well-defined Context of Use (COU) in medical product development, and/or in clinical practice. The goal of this concept is to advance strong AD/ADRD biomarkers for specific COUs by supporting development of already identified biomarkers or biomarker signatures and enabling their rigorous analytical and clinical validation within a (pre)specified COU. Applicants are encouraged to leverage existing NIA research resources and supported initiatives. Development plans should be consistent with FDA guidance. Further, applicants are also encouraged to create a path toward approval from the FDA, such as the Biomarker Qualification Program or other regulatory pathways. The funding mechanism for this concept will be a cooperative agreement, which will include substantive programmatic involvement in milestone development and project implementation.

Activities suitable for this concept include, but are not limited to:

  • Determine the biomarker’s predictive value and suitability for use to enrich for enrollment of a subgroup of AD patients more likely to respond to a novel therapeutic in Phase 2/3 clinical trials
  • Investigate the longitudinal trajectory of a biomarker to determine its clinical value for predicting conversion, as well as responses to treatment/prevention.
  • Establish reliable safety biomarkers for the detection of adverse effects
  • Validate reliable biomarkers for the determination of risk, disease detection and assessment of response to intervention, in diverse/underrepresented populations
  • Evaluate the diagnostic value of biomarkers for differentiating AD from other dementias such as vascular dementia, Lewy body dementia, frontotemporal disorders, and limbic-predominant age-related TDP-43 encephalopathy (LATE).

Scientific/Research Contacts

Yuan Luo, Ph.D.
Division of Neuroscience
Email Yuan Luo

Nadezda Radoja, Ph.D.
Division of Neuroscience
Email Nadezda Radoja

John Hsiao, M.D.
Division of Neuroscience
Email John Hsiao

Alessandra Rovescalli, Ph.D.
Division of Neuroscience
Email Alessandra Rovescalli

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Artificial Intelligence in Pre-Clinical Drug Development for AD/ADRD

Over the past 15 years, NIA’s Alzheimer’s translational research program has supported the discovery and development of new drug candidates targeting different aspects of the complex biology of Alzheimer’s disease and related dementias. Despite notable successes, such as creating a robust portfolio of new preclinical and clinical drug candidates for a diverse set of therapeutic targets, there remains a need for de-risking and accelerating key steps of the drug discovery and preclinical drug development process. Driven by the rapid growth of big biomedical data, increase in computing power, and continuous optimization of computing algorithms, artificial intelligence (AI) and machine learning (ML) methods are providing opportunities to increase the efficiency for the discovery and development of safe and effective drugs.

This is a concept for a new funding initiative that will take advantage of the rapid expansion of AI methods and their application to some of the most challenging, labor-intensive and costly aspects of drug discovery and preclinical drug development. The central goal of this initiative is to develop a robust research program that will focus on developing and using AI/ML methods to accelerate rational drug design for novel AD/ADRD targets. This program will also create advanced open-source analytical tools that will be made available to researchers in academia and biotech/pharma. Research supported through this initiative will build on NIA’s investment in the discovery of novel candidate targets and will complement the goals of the NIA-supported TREAT-AD centers whose mission is to advance novel targets into drug discovery by developing open-source target enabling research tools.

Research activities of interest include:

  1. Using AI methods to accelerate and optimize the design and synthesis of in-vivo chemical probes for novel targets identified by the Accelerating Medicines Partnership for Alzheimer’s Disease (AMP AD) and other NIA-supported target discovery programs.
  2. AI/ML-guided blood-brain barrier permeability prediction and implementation into therapeutic discovery for Alzheimer’s disease.
  3. Virtual screening for novel compounds with desired drug target binding activity, hit/lead generation and optimization, drug response, and synergy prediction.
  4. ML models for new drug design, including combinatorial libraries and predicting ‘drug-likeness’.
  5. Integration of AI/ML with 3D protein structure information for docking simulations and enhancing synthesizability of designed molecules.
  6. Modeling protein interactions and drug-target interactions using structural data.

Development of phenotype-based virtual-screening, through utilization of a variety of data types to gain insights for the mechanism of action.

Scientific/Research Contacts

Suzana Petanceska, Ph.D.
Division of Neuroscience
Email Suzana Petanceska

Nandini Arunkumar, Ph.D.
Division of Neuroscience
Email Nandini Arunkumar

Paul Grothaus, Ph.D.
Division of Neuroscience
Email Paul Grothaus

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Behavioral and Social Research on the Role of Immigration on Life Course Health and Aging, Including AD/ADRD

This concept will call for innovative minority health and health disparities research that goes beyond describing the differences observed among racial and ethnic minority communities as compared to White communities to explore how structural, community, and interpersonal mechanisms shape health outcomes and disparities among Latino, Black, Asian, and other immigrant groups in the U.S. and result in health disparities among various populations. Immigration from different countries in Latin America, Africa, Asia, and other countries to the U.S. has been increasing. Immigrants from different countries typically have lower morbidity and mortality than their U.S.-born counterparts, which is referred to as the healthy immigrant effect. The health of immigrants can, however, deteriorate the longer they stay in the U.S. The literature is mixed when it comes to the healthy immigrant effect because of variation in sending-country economic, political, and sociocultural contextual characteristics that have implications for immigrant health and aging after arrival in the destination country. Further, the experience of immigration itself can be traumatic and can affect families for generations. It is unclear what accounts for these differences.

The previous research on immigration and health has typically not employed a life course approach and has included limited measures of pre- and post-immigration which may help provide causal explanations for differences in health outcomes among immigrant groups. For example, characteristics of individuals before they immigrate, including education, health, income, political refugees, and sex could provide causal insights. Similarly, post-immigration drivers of health differences include documentation (legal status) and acculturation. For example, the lack of data on language preference and barriers, documentation, institutional policies, access to healthcare, and acculturation, makes it difficult to estimate how much the healthy immigrant effect accounts for improved life expectancy.

There are data limitations in existing studies among Latinos, Blacks, Asians, and other immigrant groups (e.g., cross-sectional rather than longitudinal data; inadequate measures of acculturation/integration in existing studies; insufficient cross-national data to address selectivity and tackle other methodological issues). Therefore, this concept includes calls for better measures of immigrant acculturation/integration, data that follow migrants across sending- and receiving-country contexts, and longitudinal data to facilitate research that takes a life course approach. These data approaches include use of existing data from the U.S. and cross-national comparisons, as well as primary data collection from the community and mixed methods for measurement development. This concept seeks to extend the literature on immigration and health and deepen NIA’s investments in research on underrepresented populations. The goal is to:

  • Expand the field of minority health in aging research by identifying factors that drive the health of racial and ethnic minority communities over time as they settle in the US,
  • Expand the field of health disparities research among racial and ethnic communities as compared to white communities and,
  • Expand the understanding of health disparities within specific racial or ethnic groups.

Scientific/Research Contact

Frank Bandiera, Ph.D.
Division of Behavioral and Social Research
Email Frank Bandiera

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Building Neuroscience Research Infrastructure for AD/ADRD in Africa

Alzheimer’s disease and related dementias (AD/ADRD) represent a substantial global health issue, especially for low- and middle-income countries (LMICs), where approximately 71% of the global cases will reside. In particular, the sub-Saharan Africa (SSA) region is expected to undergo a significant increase in the number of new cases due to the increase in the size of the older adult population.

Data on the incidence and prevalence of dementia in Africa is sparse, and related investments for AD/ADRD research in the region have been limited and persistently lacking relative to its population size. But the region’s wide variety of dietary, lifestyle and environmental exposures, as well as genetic variation, can provide valuable insights on factors that contribute to AD/ADRD. Studies of AD/ADRD in Africa will present significant research opportunities that will increase knowledge about the etiology of this family of diseases and accelerate the pace of scientific discovery. These studies can also inform intervention or prevention strategies through reciprocal innovative approaches (the bi-directional and iterative exchange of a technology, methodology, or process between two countries) for AD/ADRD mitigation within US populations.

This concept will serve as a catalytic opportunity to develop or enhance AD/ADRD research infrastructure across Africa, while supporting collaborations between US and African scientists via pilot or exploratory studies that will inform the scale up of future research. It is envisioned that this initiative will lead to the development of a consortium of AD/ADRD studies within Africa, and which can inform preventative, therapeutic and intervention strategies for US populations.

Scientific/Research Contacts

Damali Martin, Ph.D., MPH
Division of Neuroscience
Email Damali Martin

Minki Chatterji, Ph.D.
Division of Behavioral and Social Research
Email Minki Chatterji

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Chimeric Antigen Receptor (CAR) Approaches to AD/ADRD

This concept provides a proof-of-principal for a novel strategy for AD/ADRD immunotherapies and explore whether novel immunotherapeutic approaches for cancer could be repurposed as potential therapies for Alzheimer’s disease and related dementias. The approach, which combines the functions of chimeric antigen receptor (CAR) proteins and immune cells (typically T cells) into CAR-T, a promising cancer immunotherapy, has yielded unprecedented response rates against different types of blood cancers but has had limited success against solid tumors. Another type of CAR therapy, CAR-M (CAR on macrophages) has shown potential to address the shortcomings of CAR-T for a multi-faceted anti-tumor response.

The concept will examine if CAR-T and/or CAR-M technologies could be customized as treatments for AD using two approaches. The first will test if CAR-T can effectively eliminate specific types of harmful senescent cells which contribute to Alzheimer’s disease pathology in the brain, without removing beneficial senescent cell functions such as wound healing. Another path will attempt to use CARs to boost macrophages’ natural ability to degrade and eliminate harmful protein aggregates like amyloid-beta, a signature pathology of AD in the brain.

Scientific/Research Contacts

Miroslaw Mackiewicz
Division of Neuroscience
Email Miroslaw Mackiewicz

Amanda DiBattista, Ph.D.
Division of Neuroscience
Email Amanda DiBattista

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Clonal Hematopoiesis in Aging Humans: Detection, Risk Factors, Relationships to Aging-Related Pathophysiology and Conditions, and Clinical Utility in Screening and Prognosis

Clonal hematopoiesis (CH) is a condition related to aging wherein clonal expansion of cells driven by somatic mutations increases markedly with age in humans. CH is known to be associated with health risks, such as hematopoietic malignancies or increased incidence of cardiovascular disease and other age-related diseases. The term “clonal hematopoiesis of hematopoietic indeterminate potential” (CHIP) has been applied to a subset of hematopoietic clones in which cancer driver genes are found without clinical signs of hematological neoplasm and absence of cytopenia. Recent advances in genome sequencing and analysis now make it much easier to identify CH in existing longitudinal and clinical studies’ biosamples and data, with the goal of clarifying their impacts on healthy aging, disease, and longevity. Much of the underlying genetics and biological mechanisms relating to varied aging phenotypes and specifically exceptional longevity are largely undefined and under explored. Understanding the dynamics of CH in conjunction with multi-omic data in relation to physiological factors, environmental exposures, germline genetic risk factors, and gender specific effects could unravel how CH, biologically impact multiple aging phenotypes such as exceptional longevity, higher risk of age-related diseases and all-cause mortality.

This concept provides an opportunity to elucidate additional cell types of CH beyond the currently known driver genes and variants observed in CHIP. Importantly, the deleterious or protective effect of most CH mutations as a function of age remains to be established and further studies are warranted to determine if CH could potentially be a maladaptive attempt to correct aging related decline in the stem cell compartment. Possible topics for this concept include but are not limited to:

  • Prevalence and progression of CH mutations at differing ages in men and women, and in different racial/ethnic populations
  • Effects of specific CH clones and variants on health span and age-related diseases, including Alzheimer’s disease
  • Differential effects of CH in differing blood cell subpopulations on aging pathophysiology and disease risks, such as inflammatory function in immune cells and inflammatory responses in various tissues
  • Relationships of human germline variants to risk of CH, and possible mechanisms mediating such relationships. Studies on germline variants related to longevity or health span are of particular interest.
  • Environmental and other modifiable risk factors connections to CH risk and progression
  • Potential for CH screening as part of clinical blood-based tests for risk prediction and prognosis for age-related diseases

Scientific/Research Contact

Nalini Raghavachari
Division of Geriatrics and Clinical Gerontology
Email Nalini Raghavachari

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Consortium for Payment, Utilization, and Access for Dementia Care

Alzheimer's disease is the most common cause of dementia. Given that current treatments for Alzheimer’s have limited effectiveness, this concept aims to increase understanding of how health policy and interventions can be used to improve prevention and treatment of this disease. There is an opportunity to improve access, equity, efficiency and outcomes with a better understanding of policy levers that drive health system results.

To achieve these goals, this concept will support a consortium of researchers focused on economic research related to program design, payment models, utilization, incentives for drug development, and access to health services for people living with dementia (PLWD) and their caregivers. Additionally, the consortium will support cross-national comparisons to provide insights on how differences in system design can improve care for PLWD. The objective is to engage researchers on a range of related topics and use a coordinating function to build collaborations nd partnerships as well as attract new researchers and studies to the field.

The consortium will consist of one coordinating center and multiple research projects designed to provide an evidence base for policymaking. These research projects will focus on understanding how federal policies, payment models, and institutional settings affect care for PLWD; how payment mechanisms affect utilization of services and access to care; and how incentives can be optimized for Alzheimer’s care. By supporting research that determines how incentives can be optimized for Alzheimer’s care, we can reduce inefficiencies while increasing access and quality of care. The coordinating center will plan meetings, engage with stakeholders, facilitate use of common data elements, develop training programs to support a diverse research workforce, translate findings to practice, and solicit funding via national competitions for studies that directly address the NIH AD/ADRD Research Implementation Milestones.

Scientific/Research Contacts

Partha Bhattacharyya, Ph.D.
Division of Behavioral and Social Research
Email Partha Bhattacharyya

John W. R. Phillips, Ph.D.
Division of Behavioral and Social Research
Email John Phillips

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Dementia Care Coordination Research Center

There is an urgent need to better understand what works in terms of dementia care coordination and care transitions in community settings across the United States. People living with dementia (PLWD) need care that maintains their safety, promotes human dignity and autonomy, is free from medical error, is free of unnecessary care transitions, and that can be delivered in a fiscally responsible manner. All available evidence suggests that lack of care coordination and integration is frustrating, costly, and reduces safety and quality for PLWD. Community-level care integration offers the promise of helping people with AD/ADRD access the services and supports they need in the setting of their choice. However, there is wide variation in state payment and policies that support care coordination and integration, with racial and ethnic minorities and rural PLWD less likely to have access to well-integrated care.

This concept will support a Dementia Care Integration Research Center to integrate state level program data with Medicare/Medicaid data to understand dementia care access, cost of care, and variation and quality of care as PLWD go through various transitions of care in the community. A state or regional approach should include inputs from multiple stakeholders that can provide much needed insights on what works in terms of dementia care in more specific and bounded contexts. The engagement of healthcare systems and social service systems and their providers will be critical to the success of the Center. A goal of this Center will be to integrate data that is already available from in-patient and long-term care settings with data from home, community, and office-based settings so that assessment of care integration across settings can be made. Given national variation in payment and services, the vision is to incentivize research at the state level to enable research on dementia care integration. The Center will support pilot projects to understand programmatic structures in participating states, with the goal of capturing replicable state program components that are linked to higher access and quality or lower costs. The Partnership & Engagement core will build partnerships within states to capture program data and support growing partnerships to facilitate the sharing of within state program data, building on successes found in the pilot core. Hence, the cores will work together.

Scientific/Research Contacts

Elena Fazio, Ph.D.
Division of Behavioral and Social Research
E-mail Elena Fazio

Priscilla Novak, Ph.D.
Division of Behavioral and Social Research
Email Priscilla Novak

Theresa Kim, Ph.D.
Division of Behavioral and Social Research
Email Theresa Kim

John W. R. Phillips, Ph.D.
Division of Behavioral and Social Research
Email John Phillips

Emerald Nguyen, Ph.D.
Division of Behavioral and Social Research
E-mail Emerald Nguyen

Partha Bhattacharyya, Ph.D.
Division of Behavioral and Social Research
Email Partha Bhattacharyya

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Development and Validation of Harmonized Methodologies to Measure NAD+ and Related Metabolite Levels in Clinical Trials

Nicotinamide adenine dinucleotide (NAD+) is found in all cells and regulates energy metabolism, cellular repair, and circadian rhythms. Levels of cellular NAD+ have been shown to decline with age in many tissues in animal models and limited human data suggest declines with age in some tissues, with considerable variability among individuals. There is also evidence suggesting that declines in NAD+ and related factors interact with a variety of mechanisms influencing aging, including mitochondrial function, genomic integrity, epigenetic changes, and cell senescence. There has been considerable interest in the potential benefits of raising NAD+ levels to prevent or treat aging-related conditions, particularly through administration of NAD metabolites that are converted to NAD intracellularly. Collectively, these and similar interventions, supplements, and strategies are often termed “NAD+ boosters.” Studies of NAD+ boosters in old mice have reported improvements in glucose metabolism, blood flow, physical function, responses to kidney injury, and decreases in inflammatory cytokines. Not all findings are consistent across studies, with some studies showing that long-term use increased life span. NAD+ booster studies in mouse models of Alzheimer’s disease, heart failure, and stroke have also reported favorable effects. Much more limited human studies have found supplementation to be tolerable with no severe adverse events.

Further research in this area is impeded by the lack of standardized validated protocols for measuring NAD+ and related metabolites’ levels in humans. A standardized sample collection and storage protocol and common reference standards to harmonize NAD+ measurement techniques and assays are also needed. Until these tasks are accomplished, clinical trials on the effects of NAD+ boosting will continue producing uncertain results. The concept proposes funding up to three studies to develop and validate standardized protocols for measuring NAD+ and related metabolite levels in humans, including sample collection and storage, assay calibration, standardization of measurements across different types of samples, and validation of these protocols. Research teams with expertise in geriatrics, pharmacology, biochemistry, laboratory medicine, and translational aging research are encouraged. The proposed studies would be funded by the individual awards, but the awardees would be required to interact in a network consortium to exchange information, discuss their progress, pitfalls and issues arising during studies’ implementation. Specimens from the studies will be maintained after the end of the projects by the NIA’s AgingResearchBiobank or another facility for use in designing future NAD+ trials.

Scientific/Research Contact

Irina Sazonova, Ph.D.
Division of Geriatrics and Clinical Gerontology
Email Irina Sazonova

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Elucidating Variability of Physiologic and Functional Responses to Exercise Training in Older Adults

Exercise and physical activity have become increasingly recognized as an essential component of healthy aging. Despite broad evidence of their beneficial effects on health and prevention of disease, numerous investigations have shown a high degree of variability in outcomes among individuals’ response to exercise. These differences exist even under well-controlled experimental conditions, despite high adherence to structured exercise interventions across a variety of subject populations, training protocols, and outcomes. The mechanisms underlying such large variability are poorly understood, and exercise training interventions continue to be challenged by these variations, particularly in older adults.

This concept will support human studies to better understand the interrelated mechanisms and factors underlying exercise response variability in older adults. Planned study designs should assess multiple metabolic, physiologic and/or functional outcomes (for example, glucose metabolism and blood pressure, or gait speed and endothelial function, etc.). Important study considerations include, but are not limited to:

  • Dose or type of exercise
  • Exercise-drug interactions
  • Mechanisms underlying sex and age differences
  • Mechanisms underpinning the link between peripheral “muscle clocks”, energy sensing pathways, and exercise timing
  • Molecular signals and drivers of inter-organ crosstalk
  • Epigenomic, proteomic, and metabolomic mediators of responses to exercise
  • Other confounders such as pain, sleep, microbiome, behavioral and environmental factors.

Scientific/Research Contact

Lyndon Joseph, Ph.D
Division of Geriatrics and Clinical Gerontology
Email Lyndon Joseph

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Enhancing Use of Harmonized Cognitive Assessment Protocol (HCAP) Data

Global aging research aimed at strengthening our understanding of cognitive and dementia epidemiology can further non-pharmacological Alzheimer’s disease prevention and treatment intervention research at the population level to benefit vulnerable populations, both in the United States and around the world. Much can be done by examining how contextual differences across countries lead to different outcomes. Findings from these studies can help inform interventions, policy, and practice to benefit the aging population in the United States as well as globally. Rich longitudinal data capturing the social, economic, institutional, policy, cultural, and environmental circumstances people age in coupled with comparable assessments of dementia can facilitate such research. The Harmonized Cognitive Assessment Protocol (HCAP) is a sub-study within the Health and Retirement Study (HRS) in the US and within some of the studies in the HRS International Family of Studies. The HCAP seeks to measure and understand dementia risk by collecting a carefully selected set of established cognitive and neuropsychological assessments and informant reports to better characterize cognitive function among older people. Together, HCAP and HRS provide a powerful resource for cross-national research on dementia.

Prior analyses of the HRS and HCAP data demonstrate the promise of this international research. For example, HRS studies in India, Mexico, and China found that using polluting cooking fuels was associated with poorer cognitive function. Another study found that diabetes was associated with lower cognition and memory test scores in multiple countries. However, cross-national analyses of HCAP data have been relatively limited thus far and require a large investment of time and resources to use multiple datasets from different countries in varying contexts. While the harmonization of the HCAP data across countries makes this process easier, it does not eliminate these challenges. In addition, several communities of scholars that could benefit from this data are unfamiliar with the HCAP. This concept seeks to aggressively advertise and incentivize the use of HCAP and related resources to contribute to scientific advances and expand international or cross-national analyses of HCAP data. This research will help further our understanding of how different social, cultural, and institutional factors affect the trajectory of AD/ADRD in different contexts to move the field forward.

Scientific/Research Contacts

Minki Chatterji, Ph.D.
Division of Behavioral and Social Research
Email Minki Chatterji

John W. R. Phillips, Ph.D.
Division of Behavioral and Social Research
Email John Phillips

Jonathan W. King, Ph.D.
Division of Behavioral and Social Research
Email Jonathan King

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Leveraging Social Networks to Promote Widespread Individual Behavior Change

Estimates suggest that nearly 40% of all deaths in the United States are due to diseases or injuries that could have been prevented by changing health behaviors. Initiating and maintaining behavior change is difficult but may be critical for preventing or slowing the progression of diseases of aging, including AD/ADRD. A robust body of literature suggests that the behaviors of spouses, friends, family members, peers, and similar social networks have a powerful impact our own health behaviors and outcomes. However, surprisingly few interventions take advantage of social relationships to promote health behavior change, and even fewer leverage broader social networks to promote health behavior change at scale among individuals, communities, organizations, or populations, especially in mid-to-late life.

This concept capitalizes on NIA’s existing investments in the Science of Behavior Change program and the NIH Stage Model for Behavioral Intervention Development and builds off a 2022 workshop “Social Network Interventions for Diffusion of Individual Behavior Change.” It proposes a two-pronged approach to catalyze the development of future social network interventions to promote health behavior change in mid-to-late life. The first approach will solicit basic science projects that identify intrapersonal and interpersonal mechanisms of individual behavior change and test how those processes interact with social network characteristics and processes. The second will solicit planning projects to lay the foundation for future social network interventions. This two-pronged approach will prime the field to purposefully use social networks or social network data to promote widespread individual health behavior change.

Scientific/Research Contacts

Liz Necka, Ph.D.
Division of Behavioral and Social Research
E-mail Liz Necka

Laura Major, Dr.PH
Division of Behavioral and Social Research
Email Laura Major

Emerald Nguyen, Ph.D.
Division of Behavioral and Social Research
E-mail Emerald Nguyen

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Measures of Financial Hardship Among People and Families Living With AD/ADRD

Unlike other disease diagnoses, the diagnosis of Alzheimer’s disease and related dementias (AD/ADRD) does not trigger special financial protections in the US. Measures of financial hardship are not well tested among people, dyads, and families coping with AD/ADRD. Individuals with AD/ADRD progressively lose the ability to manage their own financial affairs, and over time caregivers and families often take on financial responsibilities for paying for AD/ADRD care and managing household finances. Current measures of financial strain, financial stress, and financial toxicity often fail to measure financial hardship in a way that is meaningful for people living with AD/ADRD, their caregivers, or their families. In order to accurately measure financial hardship among people and families living with AD/ADRD, validated screeners are needed. This concept will support the development of improved ways to measure financial burden and hardship for caregivers, partners, and families of persons living with AD/ADRD.

Scientific/Research Contacts

Priscilla Novak, Ph.D.
Division of Behavioral and Social Research
Email Priscilla Novak

Partha Bhattacharyya, Ph.D.
Division of Behavioral and Social Research
Email Partha Bhattacharyya

John W. R. Phillips, Ph.D.
Division of Behavioral and Social Research
Email John Phillips

Janine Simmons, M.D., Ph.D.
Division of Behavioral and Social Research
Email Janine Simmons

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National Health and Aging Trends and National Study of Caregiving Joint Renewal

The National Health and Aging Trends Study (NHATS) is a nationally representative sample of about 8,000 Medicare beneficiaries ages 65 and older that receive annual in-person interviews to collect detailed information on disability trends and individual trajectories. Additional sampling of Black and Hispanic Americans supports studies of racial/ethnic disparities in disability. Initiated in 2011 with 10 rounds of data available for public use, the study content focuses on physical and cognitive capacity distinct from the environment in which activities take place to capture both function and the potential for accommodation. To better understand the informal caregiving of NHATS participants, the companion National Study of Caregiving (NSOC) collects data from a sample of up to five caregivers providing care to NHATS participants in 2011, 2015, and 2017. The NHATS and NSOC data provide a rich understanding of disability trends, the disablement process, and its influence on wellbeing and the combination of individual data on cognition and function coupled with formal and informal care data have made the NHATS/NSOC ideal studies to examine AD/ADRD and related care.

Following the guidance of the NHATS Data Monitoring Committee (DMC), this concept proposes to renew and enhance NHATS/NSOC to support research on dementia and dementia care. Unifying the individual applications supporting elements of the study (i.e., core NHATS, NSOC, supplements for add-on samples, etc.) that have been funded under separate awards would provide a better basis for scientific review assessment of the complete study and allow the investigators to focus on the conduct of aims as opposed to producing multiple applications over the grant period. Second, an application that continued the core elements of NHATS/NSOC and expanded content to include new data elements recommended by the DMC such as enhanced cognitive/dementia measures, new sensory measures, richer dementia care measures, life course measures to capture sources of health disparities, improved residential care data, and an expanded accelerometry sample can facilitate new AD/ADRD research addressing related NIH AD/ADRD Research Implementation Milestones.

Scientific/Research Contact

John W. R. Phillips, Ph.D.
Division of Behavioral and Social Research
Email John Phillips

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Networks to Develop Behavioral and Social Science Research in Aging and AD/ADRD

While typical research grants support research and data production for many areas of behavioral and social science in aging, some high priority research areas require more nimble resources to flourish. NIA has successfully fostered emerging, high priority, transdisciplinary research areas through the development of research “networks,” flexible programs intended to support the creation of innovative research and research resources. This concept will support seven renewing research networks, each designed to broadly engage the research community and support the growth of a specific area of aging-relevant behavioral and social science:

  1. Stress Measurement: Advancing the science of psychosocial stress measurement to enhance behavioral and social surveys of aging and strengthen lab-survey linkages in the study of stress, health, and disease over the lifespan.
  2. Life Course Health and Disparities at Older Ages: Advancing interdisciplinary research to address questions about how state and local contexts shape trends and disparities in health and longevity at older ages along socioeconomic, geographic, and racial/ethnic dimensions.
  3. Aging Research on Criminal Justice and Health Disparities: Advancing behavioral and social research on aging and on health disparities and drivers of health inequities in the growing population of criminal justice-involved older adults and older adults with a history of involvement with the criminal justice system.
  4. Rural Aging: Advancing research on factors affecting the health and well-being of older people living in rural areas in the United States, and on new approaches to programs, policies, environmental modifications, and care to improve well-being, health, and function.
  5. Genomics and Omics of Behavioral and Social Sciences: Facilitating coordination of genetic association studies for social science outcomes and the introduction of multiple omics into relevant studies, including: developing platforms for interdisciplinary collaboration, supporting the development of new methods for data analysis, and the development and public dissemination of materials that will assist non-technical audiences in understanding the strengths and limitations of social genomics.
  6. Behavioral and Social Research on Aging in Animals: Advancing behavioral and social research on aging in animals to deepen the understanding of social and behavioral phenomena and processes and their links to human health and aging.
  7. Alzheimer’s and Related Dementias Data Harmonization in the HCAP Network: Supporting harmonization and collaboration across international studies conducting the Harmonized Cognitive Assessment Protocol (HCAP), a sub-study of the Health and Retirement Study, which provides new and rich data to study the prevalence, predictors, outcomes and future trends in cognitive functioning and dementia, as well as cross-national comparisons.

Research networks may support activities such as small and large meetings to develop program areas and infrastructure; small scale pilots to develop data, theoretical frameworks, empirical methods, etc.; dissemination and outreach activities; education exchange, such as intensive summer institutes, workshops, advanced seminars, or short-term residential opportunities.

Scientific/Research Contact

Lis Nielsen, Ph.D.
Division of Behavioral and Social Research
Email Lis Nielsen

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Neuronal and Non-neuronal Mechanisms Underlying Gait as a Preclinical Marker for AD/ADRD

Walking is a complex task that depends on the interplay between multiple systems (e.g., sensory, motor, cardiovascular) but also requires cognitive resources. Previous studies have found that slowing gait is associated with cognitive decline, elevated brain amyloid, and a greater risk of developing Alzheimer’s disease. However, the interaction between the shared systems that influence moving and thinking have been studied in isolation. There is also very limited information available about the cognitive resources required for motor planning and/or gait initiation in humans. The goal of this concept is to improve our understanding of the mechanisms underlying the association between gait and cognition in aging and Alzheimer’s disease and related dementias. Successful research teams will require expertise across various disciplines (e.g., gerontology, neurology, neuropsychology, neurophysiology, neuroscience, neuroimaging, exercise physiology, and physical therapy).

This concept seeks investigations in, but not limited to, the following areas:

  • Omics approaches to understand the mechanisms underlying gait, cognition, and diagnosis or progression of Alzheimer’s and related dementias
  • Neuroimaging approaches to investigate connectivity in brain networks critical for gait and cognition
  • Systems biology approaches to interrogate resilience in motor tissues within and outside the brain
  • Muscle/brain crosstalk that could affect the interaction between cognition and mobility
  • The influence of vascular dysfunction on mechanisms linking cognition and mobility
  • The influence of racial/ethnic and sex differences on the association between gait and cognition in Alzheimer’s and related dementias
  • Exploration of whether specific gait changes and cognitive decline trajectories might help distinguish between Alzheimer’s disease and other related dementias

Scientific/Research Contact

Coryse St. Hillaire-Clarke, Ph.D.
Division of Neuroscience
Email Coryse St. Hillaire-Clarke

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Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel Therapeutic Agents for AD/ADRD

To advance our shared goal of preventing and treating AD/ADRD, it is critical that we have efficient mechanisms to fund clinical trials pursuing a wide diversity of therapeutic targets and approaches to prevent, delay, and treat Alzheimer’s and related dementias. A limiting factor to the timely progression of promising pharmacological therapeutic candidates from phase 1 to phase 1b/2a clinical studies is the significant delay between the conclusion of successful phase 1 safety and tolerability studies and the start of 1b/proof-of-concept phase 2a studies. These extended timelines are in large part due to lack of funds and the timing inherent to application/funding cycles.

The phased awards generated through this concept will accelerate early-stage clinical drug development by inviting applications that bundle independent proposals for phase 1 first-in-human studies with phase 1b/phase 2a studies in relevant populations with the requirement that the studies meet prespecified, NIA approved, peer reviewed go/no-go safety and tolerability milestones to advance from phase 1. This approach will provide needed support and significantly reduce the delay between the conclusion of successful phase 1a studies and the commencement of subsequent phase 1b/2a studies. Candidate interventions evaluated through this program, which can include small molecules, biologics, or vaccines for example, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. Diversity within trial cohorts, and timely, broad access to trial data and associated biosamples will also be required.

Scientific/Research Contacts

Laurie Ryan, Ph.D.
Division of Neuroscience
Email Laurie Ryan

Akanni Clarke, Ph.D.
Division of Neuroscience
Email Akanni Clarke

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Small Research Grant Program for the Next Generation of Researchers in AD/ADRD Research

More scientists are needed to conduct the wide variety of interdisciplinary projects, including clinical, translational, prevention, and treatment research, needed to accelerate the development of innovative AD/ADRD treatments or diagnostics. This concept will support a reissuance of the “Small Research Grant Program for the Next Generation of Researchers in AD/ADRD Research” program” to build a career pipeline to encourage and support the next generation of AD/ADRD researchers and support important and innovative AD/ADRD research in a wide variety of areas where scientific investigation is needed. The overall goal of this NOFO is to support important and innovative research in areas in which more scientific investigation is needed to improve the prevention, diagnosis, treatment, and care for AD/ADRD.

This concept is especially aimed at early career investigators who have expertise in a variety of research, health, and other professional fields but have not yet had a major NIH award in AD/ADRD.

Scientific/Research Contact

Luci Roberts, Ph.D.
Division of Neuroscience
Email Luci Roberts

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Approved contract concepts for January 2023

NIA Clinical Research Support Services

NIA’s budget has substantially increased in recognition of growing public interest and urgency surrounding research on aging, including Alzheimer's disease and related dementias. As a result, NIA staff workload and responsibilities associated with managing and overseeing research grants have also increased significantly. Specific institute needs related to managing extramural clinical studies were identified and summarized in a knowledge acquisition report in 2021 which found broad support for centralized clinical research management across the NIA. To meet these needs, this concept proposes contract support in areas including patient safety, data integrity, regulatory compliance, biostatistics, clinical trial recruitment/retention, and training. This contract will reduce administrative burden on NIA staff, providing them with greater flexibility and support, and allowng them more time to focus on their scientific portfolios. It will also streamline and ensure consistencies with clinical research management processes and regulatory compliance across the institute.

Note: All applicant questions should be directed to the contracting officer.

Contracting Officer

Iris Merscher
Office of Acquisitions, NIDA/NIH
Email Iris Merscher

Scientific/Research Contacts

Holly Massett, Ph.D.
Division of Extramural Activities
Email Holly Massett

Jui Shah, Ph.D.
Division of Extramural Activities
Email Jui Shah

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NIA Information Resource Centers

To support NIA’s mission to disseminate information about health and research advances related to aging and Alzheimer’s disease, this contract will provide public inquiry response; website design, development, and hosting; publications development, printing, and warehousing; editorial and science writing support; graphic design and video production; database development and information management; communications research; conference and event support; and other communications support services. The contract includes two information resource centers: the Congressionally mandated ADEAR (Alzheimer’s and related Dementias Education and Referral) Center and the NIA Information Resource Center.

Note: All applicant questions should be directed to the contracting officer.

Contracting Officer

Karen Mahon
Office of Acquisitions, NIDA/NIA
Email Karen Mahon

Program Contact

Jessica Harper
Office of Communications and Public Liaison
Email Jessica Harper

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