Alzheimer's Tau Platform: Regimen A - AADvac1

Part of paid clinical trials in San Francisco, California.

Sponsor
Paul S. Aisen
Study ID
NCT07167966
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AADvac1 — DRUG
    Subcutaneous injection of AADvac1
  • Donanemab — DRUG
    Active comparator: intravenous infusion of donanemab

Study Details

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.

Key Dates

First listed
Sep 11, 2025
Start date
Nov 3, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AADvac1 monotherapy
    Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)
  • Experimental: Combination AADvac1 therapy with donanemab
    Intravenous infusions of donanemab for 6 months, combination donanemab and subcutaneous injections of AADvac1 for 6 months, followed by 18 months of AADvac1 injections alone (n = 150)
  • Active Comparator: Donanemab active control
    Intravenous infusions of donanemab for 6 months, combination donanemab and AADvac1-matched placebo subcutaneous injections for 6 months, followed by 18 months of AADvac1-matched placebo injections alone (n = 150).

Primary Outcome Measure

Reduction of brain tau deposition as measured by tau positron emission tomography (PET) [ Time Frame: 0, 6, 18 and 30 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Francisco (UCSF), Memory and Aging CenterSan FranciscoCalifornia94158-

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By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of California, San Francisco (UCSF), Memory and Aging Center· San Francisco, CA

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