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AADvac1 / Alzheimer Disease / Preclinical Alzheimer's Disease · Phase 2 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 adaptive platform trial registration evaluating tau-directed monotherapies (AADvac1, Tau2) alone or combined with the anti-amyloid antibody donanemab in early Alzheimer's disease. The trial is designed to measure brain tau reduction by PET at 6, 18, and 30 months as the primary endpoint, with cognitive and biomarker secondary endpoints over 30 months of follow-up. No efficacy or safety results are currently reported in this registry record.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Preclinical Alzheimer's Disease, Alzheimer Disease, Prodromal Alzheimer's Disease; age from 50 Years; to 80 Years. Intervention: Regimen A: AADvac1; Regimine B: Tau2. Compared with: Donanemab monotherapy; placebo (for initial 6-month phase).. n = 900. 2 sites: United States.
This is a Phase 2 adaptive platform trial registration evaluating tau-directed monotherapies (AADvac1, Tau2) alone or combined with the anti-amyloid antibody donanemab in early Alzheimer's disease. The trial is designed to measure brain tau reduction by PET at 6, 18, and 30 months as the primary endpoint, with cognitive and biomarker secondary endpoints over 30 months of follow-up. No efficacy or safety results are currently reported in this registry record.
No efficacy, safety, or biomarker results reported in this registry record; study is still recruiting.
This registration describes a methodologically sound adaptive platform approach to Phase 2 tau-directed therapy testing. Clinicians and researchers should monitor for results; when published, primary tau PET endpoint results will inform the potential of tau-targeted interventions but will require Phase 3 confirmation before practice application, as Phase 2 surrogates do not establish clinical benefit.
This is a study registration for a Phase 2 platform trial that is actively recruiting with no results posted; it describes planned design and endpoints only.
As stated by the source record.
Quoted from the source exactly as published.
This registration describes a methodologically sound adaptive platform approach to Phase 2 tau-directed therapy testing. Clinicians and researchers should monitor for results; when published, primary tau PET endpoint results will inform the potential of tau-targeted interventions but will require Phase 3 confirmation before practice application, as Phase 2 surrogates do not establish clinical benefit.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06957418). This is a study registration, not published results. Lead sponsor: Paul S. Aisen. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 900 participants (ESTIMATED). Conditions: Preclinical Alzheimer's Disease, Alzheimer Disease, Prodromal Alzheimer's Disease. Interventions: DRUG: AADvac1; DRUG: Tau2. Primary outcome measures: Reduction of brain tau deposition as measured by tau positron emission tomography (PET) , 0, 6, 18 and 30 months. Brief summary: The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol. This means that multiple investigational products will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. The main questions the platform trial aims to answer are: * Does a tau-directed therapy, alone or in combination with donanemab, reduce tau buildup in the brain compared to donanemab alone? * Does a tau-directed therapy, alone or in combination with donanemab, slow disease progression based on brain imaging, fluid biomarkers, and measures of memory and thinking? Participants will: * Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time. * Receive donanemab or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with donanemab. * Undergo regular cognitive testing, brain scans (MRI/PET), and biomarker assessments over 30 months Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of donanemab and tau therapy, or (3) donanemab alone. New regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available. ATP will launch with one regimen: Regimen A: AADvac1. In the future, Regimen B ("Tau2") will launch with a second tau directed therapy.
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