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Milestone 5.B

Initiate phase II (proof of concept) drug trials for agents against 3-6 currently known therapeutic targets. Of these at least 2 will be for targets involved in at-risk asymptomatic individuals (e.g. FAD or ApoE4 carriers, Down syndrome, amyloid positive, type II diabetes etc.)  These trials will be designed to provide or confirm proof of mechanism and/or evidence of target engagement for the therapeutic agent being tested. 

Success Criteria

Completion of 3-6 phase II drug trials for agents against currently known targets, providing conclusive evidence of therapeutic mechanism/target engagement.

Time Required

2015 to 2023

Research Implementation Area

Drug Development - Existing Targets

CADRO Category

C. Translational Research and Clinical Intervention

Activities, Funding Initiatives, and Resources

NIH Accelerating Medicines Partnership-AD Biomarkers Consortium
NIH ​PAR-16-365: Pilot Clinical Trials for the Spectrum of Alzheimer's Disease …
PAR-14-089: Alzheimer’s Disease Pilot Clinical Trials (R01)
NIH RFA-AG-13-015: Alzheimer’s Disease Prevention Trials (R01)
NIH RFA-AG-13-001: Alzheimer’s Disease Cooperative Study (U19)
NIH PA-16-091: Small Business Alzheimer's Disease Research (R43/R44)
NIH PA-16-092: Small Business Alzheimer's Disease Research (R41/R42)
NIH PAR-18-183: T1 Translational Research on Aging: Small Business Innovation A…
NIH PAR-18-175: Pilot Clinical Trials for the Spectrum of Alzheimer’s Disease a…
NIH PAR-18-513: Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (…
NIH PAS-18-188: Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-…

Relevant Recommendation(s)

2012 AD Summit Recommendations: 3A, 3B, 3F, and 5E