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AADvac1 / Donanemab / Alzheimer Disease · Phase 2 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 platform trial registration evaluating AADvac1, alone or combined with donanemab, in preclinical and early prodromal Alzheimer's disease. No results are reported in this registry record; the study is currently enrolling by invitation.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease; age from 50 Years; to 80 Years. Intervention: AADvac1 monotherapy; Combination AADvac1 therapy with donanemab. Compared with: Donanemab active control — Active Comparator. n = 450. 3 sites: United States.
This is a Phase 2 platform trial registration evaluating AADvac1, alone or combined with donanemab, in preclinical and early prodromal Alzheimer's disease. No results are reported in this registry record; the study is currently enrolling by invitation.
No data on safety, efficacy, or comparative effectiveness are reported.
This trial is not yet reporting outcomes. Clinicians should await publication of results to assess whether AADvac1 and donanemab combinations affect tau burden in early-stage disease and whether biomarker changes translate to clinical benefit.
This is a Phase 2 platform trial registration with no results reported; it describes a planned interventional study in early-stage disease with a surrogate endpoint (tau PET), appropriate for preliminary classification.
As stated by the source record.
Quoted from the source exactly as published.
This trial is not yet reporting outcomes. Clinicians should await publication of results to assess whether AADvac1 and donanemab combinations affect tau burden in early-stage disease and whether biomarker changes translate to 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 (NCT07167966). This is a study registration, not published results. Lead sponsor: Paul S. Aisen. Recruitment status: ENROLLING_BY_INVITATION. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 450 participants (ESTIMATED). Conditions: Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease. Interventions: DRUG: AADvac1; DRUG: Donanemab. 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 Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. Regimen A will evaluate the safety and efficacy of AADvac1, alone or in combination with donanemab.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.