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Recruiting Phase 2 Interventional

Alzheimer's Tau Platform: Master Protocol

ClinicalTrials.gov ID: NCT06957418

Public ClinicalTrials.gov record NCT06957418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 12:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Alzheimer's Disease Tau Platform Clinical Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06957418
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Paul S. Aisen
Other
Enrollment
900 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 6, 2026 (Actual)
Primary completion
Aug 31, 2028 (Estimated)
Completion
Aug 31, 2028 (Estimated)
Last update posted
Oct 26, 2026

2026 – 2028

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Banner Alzheimer's Institute Phoenix Arizona 85006 Recruiting
University of California, San Francisco San Francisco California 94158 Recruiting
University of Kentucky Sanders Brown Center on Aging Lexington Kentucky 40504 Recruiting
Brigham and Women's Hospital Center for Alzheimer Research and Treatment Boston Massachusetts 02115 Recruiting
Butler Hospital Memory and Aging Program Providence Rhode Island 02906 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37212 Recruiting
Harborview Medical Center, University of Washington Seattle Washington 98104 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06957418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 26, 2026 · Synced Oct 28, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT06957418 live on ClinicalTrials.gov.

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