NCT07167966

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
22mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 3, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

August 27, 2025

Last Update Submit

July 7, 2026

Conditions

Preclinical Alzheimer's DiseaseProdromal Alzheimer's DiseaseAlzheimer Disease

Keywords

anti-amyloid mAbmonoclonal antibody (mAB)tauamyloid

Outcome Measures

Primary Outcomes (1)

  • Reduction of brain tau deposition as measured by tau positron emission tomography (PET)

    To determine whether at least one tau therapy, either alone or in combination with donanemab, will produce a greater reduction in brain tau deposition as measured by 18F-MK-6240 PET compared to donanemab alone.

    0, 6, 18 and 30 months

Secondary Outcomes (1)

  • Disease progression as measured by plasma biomarkers

    30 months

Study Arms (3)

AADvac1 monotherapy

EXPERIMENTAL

Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)

Drug: AADvac1

Combination AADvac1 therapy with donanemab

EXPERIMENTAL

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)

Drug: AADvac1Drug: Donanemab

Donanemab active control

ACTIVE COMPARATOR

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).

Drug: Donanemab

Interventions

AADvac1DRUG

Subcutaneous injection of AADvac1

AADvac1 monotherapyCombination AADvac1 therapy with donanemab
DonanemabDRUG

Active comparator: intravenous infusion of donanemab

Also known as: Kisunla
Combination AADvac1 therapy with donanemabDonanemab active control

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco (UCSF), Memory and Aging Center

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Alzheimer DiseasePick Disease of the Brain

Interventions

AADvac1donanemab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersFrontotemporal DementiaFrontotemporal Lobar Degeneration

Study Officials

  • Adam Boxer, MD, PhD

    University of California, San Francisco (UCSF), Memory and Aging Center

    PRINCIPAL INVESTIGATOR

  • Keith Johnson, MD

    Massachusetts General Hospital (MGH), Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, ATRI

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 11, 2025

Study Start (Estimated)

November 3, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Locations

US(1)