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Incorporate imaging and/or fluid biomarkers into Phase 3 (pivotal) drug trials to select subjects and/or provide evidence of target engagement as trials for 3- 6 existing and 3-6 novel therapeutic targets are initiated.
2024 RFA-AG-13-015: Alzheimer's Disease Prevention Trials (R01) PAR-16-364: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) PAR-18-028: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) PAR-18-878: Late Stage Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) 9.E Achieved Incorporate imaging and/or fluid biomarkers into Phase 3 (pivotal) drug trials to select subjects and/or provide evidence of target engagement... DN 2012 AD Summit: 1E Biomarkers A4 Trial Anti-Amyloid treatment in Asymptomatic Alzheimer's Disease Generation Study: Alzheimer's Prevention Initiative Apolipoprotein E4 Trial Dominantly Inherited Alzheimer's Network Trials Unit – Adaptive Prevention Trial The A3 Study: Ante-Amyloid Prevention of Alzheimer's disease DIAN-TU Primary Prevention Trial A Phase 3 Pivotal Trial of AGB101 to Slow Progression in MCI due to Alzheimer’s Disease Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study (ALZ-801) 2019
Initiation of three Phase 3 (pivotal) drug trials using imaging and/or fluid biomarkers to select at risk subjects and/or for proof of target engagement.
Summary of Key Accomplishments
Eight AD Phase 3 trials for treatment/prevention have been enriched with imaging and/or fluid biomarkers. These biomarkers are used for selecting trial participants and to evaluate target engagement and treatment response. Across the eight trials, six new drug candidates (anti-amyloid) and two repurposed drugs (targeting metabolic and synaptic disfunction) are being tested/have been tested.
Per NIA’s requirements, the data and biosamples from these trials will be made available to qualified investigators from the wider research community. This is key for enabling a comprehensive success/failure analysis and evaluating responsiveness to the treatment.
The A4 trial is the first ongoing study to make the screening data and the biosamples available; one analysis of the screening data (genetic and brain imaging) revealed that non-Hispanic Blacks have lower levels of amyloid in the brain compared to non-Hispanic Whites.
The key accomplishments summary is current as of March 2022.