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Initiate Phase 3 drug trials for agents against at least 3 currently known therapeutic targets. Of these, at least one trial will be asymptomatic, at-risk populations. These trials will incorporate a combination of biomarkers (fluid and imaging) and cognitive measures as outcomes and include collection of DNA and other bio-samples for interrogation of responsiveness.
2030 RFA-AG-13-015: Alzheimer's Disease Prevention Trials (R01) PAR-16-364: Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) PAR-18-028: Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01 Clinical Trial Required) PAR-18-878: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) 5.C In Progress Initiate Phase 3 drug trials for agents against at least 3 currently known therapeutic targets… 2012 AD Summit: 3A, 3B, 3F, and 5E Drug Development - Existing Targets NIA Ongoing Alzheimer’s and Related Clinical Trials and Studies Alzheimer’s Prevention Initiative (API) Anti-Amyloid Treatment In Asymptomatic Alzheimer’s Disease Study (A4 study) Dominantly Inherited Alzheimer's Network Trials Unit - Adaptive Prevention Trial (DIAN-TU) Alzheimer’s Clinical Trials Consortium Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Open-Label Extension Study Alzheimer's Prevention Initiative Apoe4 Trial (Generation 1 Study) DIAN-TU Primary Prevention Trial The A3 Study: Ante-Amyloid Prevention of Alzheimer's Disease Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study (ALZ-801) 2017
- Comprehensive success/failure analysis of data from at least three Phase 3 trials.
Summary of Key Accomplishments
Five Phase 3 trials testing four new drug candidates for amyloid-beta-related targets have been supported. These trials include biomarkers (fluid and/or imaging) and cognitive measures as outcomes and include collection of biosamples to evaluate responsiveness to treatment. Of these:
- one trial (DIAN-TU) testing two drug candidates has been completed. While the drug treatments did not result in cognitive benefit, positive biomarker changes were observed in a subset of trial participants for one of the tested drugs.
- four trials are ongoing, one of which (A4) is expected to be completed by the end of 2022.
The key accomplishments summary is current as of July 2022.