Translational Research and Clinical Interventions Milestones
5.A-5.E, 6.A-6.J, 7.A-7.F, 8.A-8.E, 10.A-10.H, 12.A-12.L
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ID
Title
Status
5.A
Drug Development/Existing Targets: Phase 1 trials
Initiate first in human, Phase 1 drug trials for therapeutic agents against at least 6 existing therapeutic targets…
Status
In Progress
5.B
Drug Development/Existing Targets: Phase 2 trials
Initiate Phase 2 (proof of concept) drug trials for agents against 3-6 currently known therapeutic targets…
Status
In Progress
5.C
Drug Development/Existing Targets: Phase 3 trials
Initiate Phase 3 drug trials for agents against at least 3 currently known therapeutic targets…
Status
In Progress
5.D
LBD: Clinical trials
Prepare for and initiate clinical trials that aim to alleviate or slow the course of LBD symptoms, and delay or prevent the onset of disease.
Status
In Progress
5.E
Drug Development/Existing Targets: Develop disease-modifying interventions for LBD based on discovering biomarkers, molecular targets, and genetic and environmental modifiers that enhance, delay, or prevent the onset of disease
Develop disease-modifying interventions for LBD based on discovering biomarkers, molecular targets, and genetic and environmental modifiers that enhance, delay or prevent the onset of disease.
Status
In Progress
6.A
Drug Development/Novel Targets: Establish research database
Establish a searchable, open access research database that contains all clinical, biomarker, and epidemiological data, and related genotypes and phenotypes from existing genetic studies…
Status
Achieved
6.B
Drug Development/Novel Targets: Genomic efforts
Establish a consortium of genetics and genomics experts to develop and execute a large scale sequencing project to analyze the genomes of a large number of well characterized individuals…
Status
Achieved
6.C
Drug Development/Novel Targets: Target validation
Identify, characterize, and complete early validation for at least 6 novel therapeutic targets for AD and AD-related dementias…
Status
Achieved
6.D
Drug Development/Novel Targets: Novel therapeutic agents
Initiate drug discovery efforts to develop novel therapeutic agents against at least 6 novel therapeutic targets...
Status
In Progress
6.E
Drug Development/Novel Targets: Phase 1 trials
Initiate first in human, Phase 1 drug trials for therapeutic agents against at least 6 novel therapeutic targets...
Status
In Progress
6.F
Drug Development/Novel Targets: Phase 2 trials
Initiate Phase 2 (proof of concept) drug trials for agents against 3-6 novel therapeutic targets...
Status
In Progress
6.G
Drug Development/Novel Targets: Phase 3 trials
Initiate Phase 3 drug trials for agents against at least 3 novel therapeutic targets...
Status
To Be Initiated
6.H
Drug Development/Novel Targets: Mechanisms of non-pharmacological interventions
Initiate interdisciplinary research programs that integrate clinical, genomic and mechanistic research...
Status
In Progress
6.I
FTD: Genetics and epigenetics
Expand efforts to genotype patients with FTD and identify new genes and their functional relationship to FTLD pathogenesis.
Status
In Progress
6.J
Drug Development/Novel Targets: Resilience-based therapeutics
Support a diverse portfolio of candidate therapeutics including reversal or regenerative therapeutics for the treatment of advanced disease.
Status
To Be Initiated
7.A
Drug Repurposing: Multiscale models of disease
Expand existing and develop new systems biology and systems pharmacology research programs...
Status
Achieved
7.B
Drug Repurposing: Translational bioinformatics and network pharmacology
Initiate research programs for translational bioinformatics and network pharmacology...
Status
Achieved
7.C
Drug Repurposing: Data-driven drug repositioning and combination therapy
Continue to develop resources, capabilities and partnerships to advance data-driven drug repositioning and combination therapy...
Status
In Progress
7.D
Drug Repurposing: Early clinical development
Initiate early clinical development for at least 6 existing drugs or drug combinations for the treatment or prevention of AD and AD-related dementias.
Status
In Progress
7.E
Drug Repurposing: Phase 3 trials
Initiate at least three Phase 3 trials with repurposed drugs or drug combinations...
Status
In Progress
7.F
FTD: Treatments for FTD
Accelerate pre-clinical disease-modifying and symptomatic therapeutic development in FTD.
Status
In Progress
8.A
Non-Pharmacological Interventions: Research agenda development
Convene an advisory meeting to delineate an interdisciplinary research agenda focused on: advancing non-pharmacological interventions for the cognitive and behavioral symptoms...
Status
Achieved
8.B
Non-Pharmacological Interventions: Lifestyle interventions
Increase investment in clinical trials that robustly test a variety of lifestyle interventions...
Status
In Progress
8.C
Non-Pharmacological Interventions: Combined pharmacological and lifestyle interventions
Support studies that employ data-driven approaches to robustly test the efficacy of multi-modal interventions...
Status
To Be Initiated
8.D
Non-Pharmacological Interventions: Prevention trials
Initiate at least one clinical trial for primary prevention of AD and AD-related dementias among high risk individuals...
Status
In Progress
8.E
VCID Clinical Trials: Interventions to reduce vascular risk factors
Test for efficacy across the spectrum of VCID severity
Status
In Progress
10.A
Trial Design: Interpretation of trial data
Convene a meeting that brings together epidemiologists, clinical trialists, clinical practitioners, representatives from industry and patient advocates from diverse communities to formulate guidelines...
Status
In Progress
10.B
Trial Design: Standard outcome measures
Establish a working group to identify standard outcome measures necessary for data comparisons across secondary prevention trials...
Status
Achieved
10.C
Trial Design: Studies using common standard outcome measures
Initiate 3-4 clinical research studies using common standard outcome measures...
Status
Achieved
10.D
Trial Design: Precision medicine
Create new research programs to implement innovative trial designs with a precision medicine research paradigm.
Status
In Progress
10.E
Trial Design: Dissemination methodologies
Support research on the effectiveness of dissemination methodologies to facilitate the implementation of effective prevention strategies.
Status
To Be Initiated
10.F
Trial Design: Experimental medicine approach to primary prevention
Convene an advisory meeting to evaluate how assays and best practices developed in the context of the NIH Common Fund Science of Behavior Change...
Status
Achieved
10.G
Health Equity: Optimize vascular health trial design for diverse populations
Enrich the design of trials of vascular health interventions to improve their application to AD/ADRD among aging diverse populations.
Status
In Progress
10.H
Health Equity: Design culturally tailored interventions
Implement culturally tailored multimodal intervention trials and drug therapy trials reduce AD/ADRD burden
Status
Achieved
12.A
Recruitment: Diverse community partnerships
Provide funding for clinical research studies to build diverse community partnerships needed to increase research participation.
Status
In Progress
12.B
Recruitment: Federally funded synergies
Create synergies between federally funded programs such as PCORI and CTSAs to make community involvement less expensive...
Status
In Progress
12.C
Recruitment: Logistical barriers
Provide supplemental support for clinical research on AD and related dementias to overcome the major logistical barriers to participation...
Status
In Progress
12.D
Recruitment: Streamlining participant consent
Convene a meeting with key stakeholders and organizations including representatives from the NIH Precision Medicine Initiative ...
Status
To Be Initiated
12.E
Recruitment: Electronic consent pilot
Pilot the use of electronic consent which provides participants an option for broad sharing of de-identified data...
Status
In Progress
12.F
Recruitment: Citizen science
Develop and deploy citizen science methods to engage diverse and underrepresented populations...
Status
In Progress
12.G
Recruitment: Federal public education campaign
Establish a partnership among NIH and other federal agencies to develop a national public education campaign...
Status
In Progress
12.H
Recruitment: Share best practices
Collaborate with research scientists to identify, evaluate and increase knowledge about best practices for recruitment and retention of research participants.
Status
Achieved
12.I
Recruitment: Update central resources
Establish a working group including clinical trial recruitment experts to dynamically evaluate and update the materials and information provided in the central resource.
Status
Achieved
12.J
Recruitment: Awareness of registries
Collaborate with external organizations to increase awareness of large-scale registries that encompass the spectrum of the disease ...
Status
Achieved
12.K
Health Equity: Inclusion and retention of underrepresented populations in clinical research
Develop novel and identify existing community engagement and outreach methods to facilitate engagement, understanding and partnership with health disparities populations.
Status
Achieved
12.L
Health Equity: Inclusion of diverse communities in AD/ADRD research
Advance equity in AD/ADRD research via inclusion science to improve representative sampling and retention of diverse communities.
Status
In Progress