On Monday, July 30, I presented, on behalf of NIH Director Dr. Francis Collins, the Fiscal Year 2020 NIH Professional Judgment Budget for Alzheimer’s Disease and Related Dementias at the meeting of the HHS Secretary’s Advisory Council on Alzheimer’s Research, Care, and Services. The estimate—commonly referred to as a Bypass Budget—is based on scientific opportunities that NIH could pursue to achieve the research goal of the National Plan to Address Alzheimer’s Disease—to prevent and effectively treat Alzheimer’s disease by 2025.
NIH estimates we will need a total of $2.393 billion in FY 2020 to keep us moving toward the 2025 goal. In FY 2018, funding for this research was an estimated (enacted) $1.9 billion. This latest Professional Judgment Budget estimates $876.7 million in additional funds needed relative to the FY 2019 President’s budget proposal—comprising $399 million to compensate for proposed reduced funding in FY 2019 and $477.7 million in additional investment.
Developing infrastructures and partnerships
This year, we discuss progress in building a national research infrastructure. We have new tools, technologies, and approaches—from supporting the ideas of individual investigators to the collection and analyses of vast amounts of data from populations worldwide. These advances are largely a result of unprecedented partnerships among government, advocacy groups, foundations, thought leaders, and pharma, biotech, and technology companies.
This report describes our progress to date, new initiatives underway, and the type and cost of additional research in FY 2020 that will help move us toward the goal of effectively treating or preventing Alzheimer’s and related dementias (AD/ADRD) by 2025. Our efforts are broad and far-reaching. We are:
- Enabling precision medicine research through advances in genomic sciences and deep molecular phenotyping of existing cohorts and the launch of new diverse cohorts
- Using the open science research model of the Accelerating Medicines Partnership for Alzheimer’s Disease to hasten the discovery of the next generation of therapeutic targets and biomarkers
- Creating new translational infrastructure programs to enable rapid sharing of data and research models and enhance research rigor and reproducibility
- Developing emerging therapeutics in academic centers and in the small business community
- Making advances in disease monitoring, assessment and care, powered by the revolution in mobile technology, which are helping us bring in people living with AD/ADRD, and their caregivers, as direct partners in research
Several efforts focus on “open science,” a participatory approach to research in which progress is accelerated by making research data, methods, and tools available to all qualified investigators. NIA has been taking a leadership role in promoting the broad availability of research data for quite some time. It’s particularly important that we continue to do so at a time when the rise of big data and new analytical approaches help us to better understand human wellness and disease in a person-specific manner.
We cannot succeed in these efforts unless we engage the public and secure the commitment of people from all walks of life to participate in clinical research. With facilitation by the Alzheimer’s Association, in collaboration with private, academic and industry stakeholders, the broad strategy is to find ways to step up recruitment to clinical studies as a way to accelerate treatments for this devastating disorder. We are looking forward to launching this multi-pronged strategy by the end of the summer.
Expanding funding opportunities
We’re also looking forward to supporting more AD/ADRD research projects in the months ahead. In the meantime, remember that you can see our current AD/ADRD funding opportunities now. We are seeking innovative, high-quality proposals in a wide range of areas. I’d also like to remind you that we’re posting information on concepts for new FOAs very soon after they’ve been cleared by our National Advisory Council on Aging. While these concepts are not yet FOAs, they do give you an idea of our research priorities.
We also expanded our existing supplement program to invite existing grants not focused on Alzheimer’s to add an aim on Alzheimer’s to their awards. This year we invited all NIH Institutes to take part in the program. Nearly all of them did and we have received a very robust response to this effort. We hope it turns into new avenues to solve the challenging problem of Alzheimer’s disease and its related dementias.
Expanding the Alzheimer’s research community
With the recent increases in funding, NIH has been monitoring the capacity of the scientific community to offer even more high-quality research proposals to match. As part of this analysis, NIA has found that in FY 2015-2017, more than one-quarter of NIA’s Alzheimer’s and related dementias awardees were either new or early stage investigators and one-third were established investigators who were new to the field of AD/ADRD.
Together, we make the difference
Alzheimer’s disease and related dementias affect millions of people and their families. Advances in science and technology, along with increased financial support, have helped researchers better understand these diseases and identify potential ways to prevent and delay them. Thanks to the renewed commitment from the American public, the dedication of study volunteers and their families, and the relentless work of researchers and clinicians, NIH-supported researchers, and the AD/ADRD community at large, we have identified promising pathways to effective therapies. Together, we can make the difference.Alzheimer's Disease Budget Research Richard HODES
NIA staff are gearing up for the annual Alzheimer’s Association International Conference (AAIC) 2018, taking place this year in Chicago, July 22-26. AAIC is dedicated to advancing dementia science, and we’re looking forward to attending alongside thousands from the Alzheimer’s community.
AAIC is an opportunity for dementia researchers, clinicians, advocates, and health care providers from around the world to share research discoveries, learn about emerging technologies and new approaches, and advance our shared goals of discovering effective treatments and preventions for Alzheimer’s disease and related dementias. Many of the discussions and presentations will center on projects and collaborations supported by NIH.
Where can you find NIA staff?
NIA leadership and staff are participating in several sessions, so keep an eye out for us if you want to touch base. If you’re interested in NIH projects and/or support, here are a few sessions you may want to catch:
- Tuesday, July 24, 10:30 – 11:00 a.m.
The Winds of Change: Transformative Data Resources for Alzheimer’s Research
In this plenary session, NIA Director Dr. Richard Hodes will talk about innovative ways to conduct research, share data, and translate findings into practice. Cutting-edge research conducted and supported by NIA and other NIH institutes has helped to revolutionize the way we think about Alzheimer’s disease and related dementias.
- Monday, July 23, 4:15 – 5:45 p.m.
New NIH Policies on Inclusion – Implications for Alzheimer’s Clinical Study Recruitment and Tools to Help
NIA Deputy Director Dr. Marie Bernard and I will chair this session, which will provide an overview of recent NIH initiatives to support increasing recruitment and retention into clinical studies for Alzheimer’s disease. NIA staff will present results of a trans-NIH portfolio analysis of inclusion showing a need for increased recruitment of a broad spectrum of people; progress on a national strategy for Alzheimer’s disease clinical study recruitment; and a new funding opportunity to enhance the science of recruitment.
- Monday, July 23, 2:00 – 3:30 p.m.
NIA Health Disparities Research Network: Novel Approaches for Addressing Alzheimer’s Disease and Related Dementias
Dr. Carl Hill, director of NIA’s Office of Special Populations, and Dr. Cerise Elliott, senior scientific program analyst in our Division of Neuroscience, will serve as co-moderators of this session, which will highlight currently funded research focusing on health disparities in Alzheimer’s disease. Eight presentations and accompanying discussions will provide important research approaches for addressing health disparities over the life course and in late life.
- Wednesday, July 25, 2:00 – 3:30 p.m.
Operationalizing the NIA-AA AD Research Framework
The new National Institute on Aging-Alzheimer’s Association research framework outlines a biological approach for defining Alzheimer’s disease designed to facilitate better understanding of the disease process and result in a faster approach to testing interventions. This symposium will provide an overview of the framework and include a discussion on criteria for its future evaluation.
In a pre-conference workshop on Saturday, July 21 from 2:00 to 5:00 p.m., Sage Bionetworks will launch a tool to help researchers leverage analyses from the NIA-funded Accelerating Medicines Partnership – Alzheimer’s Disease (AMP-AD) program. The interactive, web-based Agora platform will include a list of potential Alzheimer’s disease drug targets nominated by the AMP-AD teams, allowing researchers outside the consortium to get involved in target evaluation.
I hope you’ll take the time to stop and chat with NIA and NIH staff you see at the various presentations, poster sessions, and gatherings. It’s a great time to connect with colleagues, students, mentors, and everyone interested in Alzheimer’s research. See you in Chicago!Alzheimer's Disease Meetings Research Eliezer MASLIAH
If we roll back the clock 12 months, we’ll see that, back then, NIA issued a call for administrative supplements for existing NIA grantees to add an aim on Alzheimer’s disease (and its related dementias) to a grant that was not already studying Alzheimer’s or its related dementias. This year, we decided to open the field up a little and include other NIH institutes. We reckoned that one or two other NIH institutes would have grantees interested enough in Alzheimer’s (or its related dementias) to submit applications, too. You can imagine the ones we had in mind—NINDS, NIMH, maybe NIBIB. (NIBIB did participate last year.)
Twenty-three institutes, centers, and offices answered our call. Yes, 23! And NICHD recently made it 24 by joining with a late Notice of their Participation. (In fact, so many Institutes signed up for the Notice that we overloaded the NIH software designed to handle these collaborative announcements – clearly it was not designed to handle quite this much collaboration!)
Why the widespread interest?
What happened? It is easy to be a little cynical and say that everyone is simply chasing the money NIA received in our most recent appropriation. Something more is going on, though. Interest in Alzheimer’s has spread throughout the NIH community. Recognition of the current problem and anticipation of the much larger problem if no solution is found is now widespread. That recognition is not only in the public’s eye, it’s caught the imagination of scientists across a wide variety of fields.
Of course, with so many institutes participating it is easy for confusion to reign. We’ve heard comments like “I heard a rumor that this opportunity was only for the other Institutes, not for NIA grantees.” Good grief! It is absolutely for NIA grantees! In fact, we expect more applications from NIA than from all other institutes combined. If your field is aging, then you already have a pathway that can identify a connection to Alzheimer’s.
To make sure that there’s no confusion, here are the details:
- The announcement is NOT-AG-008.
- You apply using the parent administrative supplement FOA.
- The deadline for submission is June 8.
- We allow up to $250,000 in direct costs for one year only.
- NIA grants really, really, really are eligible!
- These funds are applicable to a grant that is not already studying Alzheimer’s or related dementias.
Read the announcement to help you understand what kind of research is likely to be appropriate. I recommend also that you contact your program officer to discuss whether what you are proposing is within scope of the award.
On another note: Funding lines
Some of you have been asking about whether we will have increased funding lines this year given the generous appropriation. If I were you, I’d wonder that, too. Inside NIH though, we must follow a protocol. We wait for that dance to end. Then we can post funding lines. So, stay tuned!Alzheimer's Disease Dementia Funding Opportunities Robin BARR
If you run a small business, are thinking of starting a small business, or have an idea focused on Alzheimer's disease and Alzheimer’s-related dementias (AD/ADRD) that has a commercial side, then this blog is for you! Whether your focus is therapeutic drug development, systems of care, effects on families, or something else, there are opportunities for you through our small business research and development (R&D) programs – known as SBIR (Small Business Innovation Research) and STTR (Small Business Technology Transfer Research).
NIA’s SBIR and STTR grant mechanisms fund eligible small businesses to conduct aging- and health-focused R&D leading to the development of innovative products and services to improve the health and well-being of older Americans. In fiscal year 2018 (which ends on September 30, 2018), we expect to provide more than $70 million in funding for small business innovation in R&D on aging-related conditions and concerns, including and especially Alzheimer's disease (AD) and AD-related dementias (ADRD).
NIA is the lead federal agency sponsoring research on AD/ADRD and has been granted an unprecedented budget to address and develop interventions and therapeutics that prevent, treat, or even cure AD/ADRD.
Consequently, we have a unique opportunity to expand and enrich our small business R&D programs that focus on commercialization—including drug development—of AD/ADRD-focused products and/or services. These products include, but are not limited to:
- Mobile technology to monitor and assess daily functions of people with AD/ADRD
- Testing compounds shown to extend life span or health span in AD/ADRD animal models
- Translation of clinical guidelines into new and effective tools for clinical care and management of AD, ADRD, and associated comorbidities.
- New tools and methodologies to prevent, diagnose, treat, and care for people with AD/ADRD.
- Socially assistive robots to help people with AD/ADRD and their caregivers
Truly, we have not seen a better time for applicants with new and different ideas and approaches. We’re supporting awards in areas unrelated to AD/ADRD, as well. We are looking to attract small businesses that have never before considered or participated in these programs. If you’re completely new to the process, a good place to start is the NIH SBIR/STTR site.
The next application deadline—April 5th—is just around the corner. If you can’t make that deadline, please consider preparing an application for September. There are three annual application deadlines: January 5, April 5, and September 5.
For more information, including contact information, learn more about NIA’s small business programs. We look forward to connecting with you about your ideas and innovations!Alzheimer's Disease Small Business Funding Michael-David KERNS
March Madness—a time for bracket busting and bragging rights, Cinderella stories and unexpected outcomes.
And, so it goes in NIA-supported research, too! We in the Division of Behavioral and Social Research (BSR) know that many researchers think of us as the “demography division,” but there’s much more to us than that. We’ve been developing our game in new directions—funding more research in Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) and fostering cross-disciplinary research, at multiple levels from genetics to cross-national comparative research, and at stages from basic through translational research in AD/ADRD. The research spans a wide range of interests including dementia care and caregiving across a variety of settings, epidemiology and demography, pathways to AD/ADRD and its prevention, early psychosocial changes, and health disparities.
It’s exciting to see some of the results so far. For instance, we’ve supported research showing that while higher educational attainment appears to protect against the risk for dementia with the degree of risk varying as a function of race and ethnicity, the underlying psychosocial pathways remain unknown (Langa et al., 2017). Another recent BSR-supported study showed that an individualized music program is associated with improved outcomes for U.S. nursing home residents with dementia (Thomas et al., 2017). And, still other research has shown that poor caregiver mental health was associated with increased patient mortality, even after controlling for sex, age, dementia severity, and patient mental health (Lwi et al., 2017).
We also team up with other extramural divisions within NIA (and other NIH Institutes) to sponsor a range of AD/ADRD activities including workshops, summits, and other scientific activities. For example, together with colleagues in the Division of Neuroscience, we sponsored a recent workshop on Cost-Effective Early Detection of Cognitive Decline. Another prime-time matchup last October was the National Research Summit on Care, Services and Supports for Persons with Dementia and Their Caregivers. That team effort involved a host of stakeholders and generated a large number of recommendations, several of which fed directly into two current initiatives: “Disparities in Quality and Access to Dementia Care” and “Improving the Lives of Persons with Dementia (PWD): Impacts on PWD, Families and Communities,” both of which are described in the recent Notice to Specify High-Priority Research Topics for PAR-18-596.
Get in the game!
The upshot is, we think it is important and have the additional resources to grow research that targets behavioral and social studies in AD/ADRD. Research in the social sciences is crucial to getting a full picture of how AD/ADRD is going to affect the U.S. in the next several decades. We hope that our work to support behavioral science, epidemiology, dementia care and caregiving, and health services research will make a difference in the lives of people affected by the disease. To that end, we’ve issued several new funding opportunity announcements (FOAs) that exemplify the range of AD/ADRD research supported in our division:
- Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings – Contact: Dr. Partha Bhattacharyya
- Dementia Care and Caregiver Support Interventions – Contact: Dr. Lisa Onken
- Towards Implementing Novel Training Methods to Enhance Cognition in Aging – Contact: Dr. Jonathan King
We also support small business research in AD/ADRD, from socially assistive robots for people with dementia and their caregivers to virtual reality for assessing functional performance, including this currently active small-business FOA:
- Assistive Technology for Persons with Alzheimer's Disease and Related Dementias and Their Caregivers – Contact: Dr. Dana Plude
Please take a look at the FOAs relevant to BSR’s AD/ADRD research mission. Almost all of them are open at least until this fall; many will remain open for two to three years. You can also see a full list of NIA-wide FOAs and NIA-wide AD/ADRD FOAs.
You gotta be in it to win it!
As difficult as it is to have a winning bracket in the NCAA basketball tournament, it’s at least that hard to predict which application will succeed in advancing our understanding of behavioral and social factors related to AD/ADRD and its challenges. Nevertheless, we encourage you to prepare and submit applications and contact us with questions about the research we support and the FOAs we sponsor.Alzheimer's Disease Applications Funding Opportunities Small Business Funding Dana PLUDE
It’s hard to recruit people for clinical research these days. And that is doubly true if the topic is Alzheimer’s disease and its related dementias. Recruiting volunteer participants is a primary, persistent bottleneck that poses unique challenges to clinical trials researchers. Among these challenges are strict eligibility requirements for participation of study partners, sometimes invasive and time-consuming procedures, and barriers for underrepresented communities. A newer aspect is the engagement of pre-symptomatic or healthy volunteers as we try to intervene as early as possible in the disease process.
Developing a national strategy
To address increasing concerns about difficulties in reaching study recruitment goals, the NIA, with co-facilitation from the Alzheimer’s Association and other organizations, is asking a wide range of stakeholders, particularly those underrepresented in research, to help develop a comprehensive National Strategy for Alzheimer’s Disease Clinical Research Recruitment and Participation. We very much want to hear ideas and views from the academic and pharma research communities, patients and families, clinicians and other health care providers, businesses and employers, advocates, government and community leaders, communications experts, research funders, and more. In short, we need you—to help formulate that Strategy and join in its implementation.
Join the conversation!
We are currently seeking public comment for feedback on the ideas generated by the working groups. We’re also soliciting new ideas, aiming to fill gaps. For this outreach, we are trying something new to NIA, but which has been used across NIH and HHS recently for just this sort of conversation—a crowdsourcing platform called IdeaScale. Different than a traditional Request for Information, this online platform will allow us to hear from and engage with diverse stakeholders, creating a dialogue among participants.
How does this crowdsourcing thing work?
To comment, please visit and join our IdeaScale community, to browse ideas that have already been submitted, comment, cast a non-binding vote for your favorites, and submit your own ideas. It is vital that participation and comment reflect a diverse array of perspectives and priorities. So, please, invite others—colleagues, relatives, or friends who might have a good idea about what works and what doesn’t in encouraging study participation—to be part of the discussion as well. We’re seeking ideas in key topic areas such as:
- Optimizing recruitment by building trusting relationships in local communities,
- Raising national awareness about participation in studies,
- Enhancing the capacity of study sites,
- Tracking our progress, and
- Cultivating a science of recruitment.
The public comment period is planned to run through April 15.
What’s happened so far to develop a strategy?
Over the past year, an initial group of dedicated volunteer experts has worked to draft initial recommendations. To name just a few, we want to thank our co-facilitators at the Alzheimer’s Association, members of a Strategy steering committee, and tireless working groups led by:
- Dr. Jason Karlawish, Outreach, Recruitment, and Education core leader, University of Pennsylvania School of Medicine Alzheimer’s Disease Research Center, who chaired the working group focusing on national approaches
- Dr. Pierre Tariot, director, Banner Alzheimer's Institute and co-director, Alzheimer's Prevention Initiative, who chaired the working group on capacity building
- Dr. Laura Baker, associate director, Wake Forest Alzheimer’s Disease Core Center, who chaired the working group focusing on local and diverse efforts.
They looked at recruitment and retention from the national and local perspectives, and what actions are needed to enhance messaging, partnering, building study site capacity and more. Their dedication, diligence, and thoughtfulness are the foundation for the wider discussion we invite today.
What happens next?
After receiving your ideas, we’ll be analyzing and organizing them, with the working groups and others, to view and evaluate the input we’ve received. We’ll finalize the national recruitment strategy document over the next few months.
But that is only the beginning. The Strategy can only succeed when we all take part in real action to move forward. We’re eager to continue the conversation and with your help, to implement the components of the Strategy to optimize participation in Alzheimer’s and related dementias research.Alzheimer's Disease Clinical Research Eliezer MASLIAH
The NIA-supported Alzheimer’s Disease Centers (ADCs) have long been a crucial part of NIA’s overall Alzheimer’s disease program and have many accomplishments to their credit. During this time of expanding interest and support for Alzheimer’s research, NIA is introducing important changes to this Centers program. We hope these changes will equip the Centers to respond effectively to the greater demands upon them as the pace of research intensifies and to continue in their leadership role in Alzheimer’s research.
A new Funding Opportunity Announcement includes some of these changes. These new grants will offer centers more flexibility, expanded cores, and reflect an increase in funding to help foster the best science possible.
New flexibility, increased funding
Integrating transformative recommendations from an expert panel, the strategically revised ADC program can better facilitate achieving National Plan to Address Alzheimer’s Disease objectives. The new ADCs will increase flexibility and collaboration by leveraging resources, capabilities, and research participants across the network of centers.
Starting with this FOA, future ADCs all will be funded through the P30 mechanism. In the past, the P50 awards included funding for up to three projects and all centers had two pilot projects per year. In the new P30 FOA, all centers have “developmental projects” with a flexible duration, allowing multiple projects throughout the five years of the award rather than being limited to three fixed projects as in the P50 model. Similarly, the new FOA allows variable time-frames for projects and more resources for each project, especially compared to the one-year pilot grants.
NIA intends to commit $16 million in FY 2019 to fund an estimated five to seven centers in response to the new FOA.
New and optional cores
ADCs are now required to include six (rather than five) cores and a new research education component. They are also expected to add optional cores reflecting the theme(s) and expertise at each institution.
A required biomarker core is a new element of the current funding opportunity to help ADCs facilitate cutting-edge research. Although the core is required, the choice of biomarkers is flexible. They may be familiar or novel. They may be fluid or image biomarkers, or a different type altogether: wearable or in-home, mobile and/or vehicle—provided that they contribute to improved understanding and diagnostics for Alzheimer’s disease.
With the additional center funding, we’re also expecting to see some unique new cores across the network of centers, as well as others that are able to work collaboratively with similar cores at different centers.
Clearly identifying centers and their contributions
NIA-funded ADCs have contributed significantly to Alzheimer’s research for more than 30 years and are central to achieving NIH’s Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) research goals. Alzheimer’s Centers are at the nexus of fundamental, mechanistic research, clinical trials, population health research, and health services research. They are major sources of discovery into the nature of AD/ADRDs and the development of more effective approaches to prevention, diagnosis, care and therapy. The ADCs’ infrastructure and resources support grants and research locally, nationally, and internationally.
ADCs have contributed to numerous large genetic studies, developed amyloid imaging, furthered our understanding of heterogeneity, and have helped set standards and develop tools for clinical care. Additionally, they provided and continue to provide researchers with valuable resources, such as biological specimens and tissue from well-characterized subjects, including those who have had a neuropathological evaluation—something that is unique globally in terms of numbers and diversity of tissue and other samples, as well as level of expertise for analysis of those biospecimens.
The Centers are the anchors of this stepped-up federal research effort and a key public investment. To reflect this commitment, we’re introducing a new acronym and look. This next generation of Centers will be identified as “NIA-designated Alzheimer’s Disease Research Centers,” or ADRCs for short, and will be marked by a new “badge” that will help identify them. NIA-funded ADRCs can use it exclusively on their websites, as well as on outreach and informational materials from those centers, with permission from NIA.
We are very excited to move into this next generation of Alzheimer’s Disease Research Centers in many communities. We invite the full research community to connect and collaborate with the ADRCs in new ways as we work together toward better treatments and prevention.Alzheimer's Disease Applications Funding Opportunities Richard HODES Nina SILVERBERG