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Initiate Phase 3 drug trials for agents against at least 3 novel therapeutic targets. These trials will incorporate a combination of biomarkers (fluid and imaging) and cognitive measures as outcomes and include the collection of DNA and other bio-samples for the interrogation of responsiveness.
2035 PAR-18-878: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) PAR-18-513: Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01) 6.G In Progress Initiate Phase 3 drug trials for agents against at least 3 novel therapeutic targets... 2012 AD Summit: 3A, 3B, 3F, and 5E Drug Development - Novel Targets NIA Ongoing Alzheimer’s and Related Clinical Trials and Studies A Phase 3 Pivotal Trial of AGB101 to Slow Progression in MCI due to Alzheimer’s Disease: HOPE4MCI Trial Metformin in Alzheimer's dementia Prevention (MAP) NIA-AA Symposium: Enabling Precision Medicine for Alzheimer's Disease Through Open Science 2022
Comprehensive success/failure analysis of data from at least three Phase 3 trials.
Summary of Key Accomplishments
In 2025, Annovis Bio initiated a Phase 3 randomized, placebo-controlled trial of the investigational drug buntanetap (Posiphen) to treat early Alzheimer’s disease in adults aged 55-85 years. Buntanetap targets production of several disease relevant proteins, including both amyloid and tau. Outcome measures will include cognitive and functional assessment as well as imaging biomarkers. While this is an industry-sponsored trial, the molecule was designed and developed in the NIA Intramural Research Program, and NIA funded preclinical development, safety testing, and early clinical trials. Investigators estimate that the trial will be completed in 2028.
The key accomplishments summary is current as of September 2025.