Alzheimer's Tau Platform: Master Protocol (NCT06957418) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
900 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range50 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Documentation of the participant's informed consent to study procedures (including APOE genotyping).
✓. Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum CDR-SB \<1.5
✓. Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB \<1.5).
✓. MMSE score at screening of 20-30 (inclusive) with educational adjustments:
✓. If \<12 years of education, MMSE required to be \>20.
✓. If 13 to 15 years (inclusive) of education, MMSE required to be \>22.
✓. If \>16 years of education, MMSE required to be \>24.
✓. Plasma biomarker result at screening that demonstrate the presence of amyloid pathology, consistent with preclinical-prodromal AD.
Exclusion criteria
✕
What they're measuring
1
Reduction of brain tau deposition as measured by tau positron emission tomography (PET)
. Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.
✕. Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to use highly effective method of contraception for the duration of their participation in the study. Males who are sexually active with a female of childbearing potential and do not agree to use barrier methods of contraception (condoms with spermicide) during the trial and for 6 months after the last dose of study drug unless the female is using a highly effective method of contraception.
✕. Lacks good venous access such that multiple blood draws would be precluded.
✕. Weighs less than 40kg, or more than 136kg at screening.
✕. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available regimen.
✕. Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received placebo in the previous study.
✕. Prior or current treatment with a prohibited medication as described per protocol.
✕. Enrollment in another investigational study as described per protocol. Participants enrolled in an observational study may be permitted with Medical Monitor review and approval.