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Alzheimer's Tau Platform: Regimen A - AADvac1

NCT07167966 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Preclinical Alzheimer's Disease
  • Prodromal Alzheimer's Disease
  • Alzheimer Disease

Interventions

DRUG

AADvac1

Subcutaneous injection of AADvac1

DRUG

Donanemab

Active comparator: intravenous infusion of donanemab

Sponsors & Collaborators

  • Axon Neuroscience SE

    collaborator INDUSTRY

  • University of California, San Francisco

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Alzheimer's Therapeutic Research Institute

    collaborator OTHER

  • Alzheimer's Clinical Trials Consortium

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Paul S. Aisen

    lead OTHER

Principal Investigators

  • Adam Boxer, MD, PhD · University of California, San Francisco (UCSF), Memory and Aging Center

  • Keith Johnson, MD · Massachusetts General Hospital (MGH), Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07167966 on ClinicalTrials.gov