Alzheimer's Tau Platform: Regimen A - AADvac1

NCT ID: NCT07167966

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-08-31

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 an anti-amyloid monoclonal antibody (mAb), 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 an anti-amyloid mAb.

Detailed Description

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 an anti-amyloid mAb, 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 ATP Master Protocol is registered as NCT06957418.

Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into a currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

Participants randomized to Regimen A - AADvac1 will be randomized in a 2:2:1 ratio to either AADvac1 alone, combination AADvac1 therapy with an anti-amyloid mAb, or an anti-amyloid mAb active control. The allocation ratio may be change based on the number of concurrent active regimens to ensure appropriate number of individuals randomized to the control arm across all active regimes.

Regimen A will enroll by invitation, as participants may not choose to enroll in a given regimen. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen A.

For a list of enrolling sites, please see the ATP Master Protocol under NCT06957418.

Conditions

Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AADvac1 monotherapy

Intravenous infusions of anti-amyloid mAb-matched placebo for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)

Group Type: EXPERIMENTAL

AADvac1

Intervention Type: DRUG

Subcutaneous injection of AADvac1

Combination AADvac1 therapy with anti-amyloid monoclonal antibody (mAb)

Intravenous infusions of an anti-amyloid mAb for 6 months, combination anti-amyloid mAb and subcutaneous injections of AADvac1 for 6 months, followed by 18 months of AADvac1 injections alone (n = 150)

Group Type: EXPERIMENTAL

AADvac1

Intervention Type: DRUG

Subcutaneous injection of AADvac1

Anti-amyloid Monoclonal Antibody (mAb)

Intervention Type: DRUG

Active comparator: intravenous infusion of an anti-amyloid mAb

Anti-amyloid monoclonal antibody (mAb) active control

Intravenous infusions of an anti-amyloid mAb for 6 months, combination anti-amyloid mAb and AADvac1-matched placebo subcutaneous injections for 6 months, followed by 18 months of AADvac1-matched placebo injections alone (n = 75).

Group Type: ACTIVE_COMPARATOR

Anti-amyloid Monoclonal Antibody (mAb)

Intervention Type: DRUG

Active comparator: intravenous infusion of an anti-amyloid mAb

Interventions

AADvac1

Subcutaneous injection of AADvac1

Intervention Type: DRUG

Anti-amyloid Monoclonal Antibody (mAb)

Active comparator: intravenous infusion of an anti-amyloid mAb

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).

Exclusion Criteria:

• No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol (NCT06957418).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axon Neuroscience SE

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Alzheimer's Therapeutic Research Institute

OTHER

Sponsor Role: collaborator

Alzheimer's Clinical Trials Consortium

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Paul S. Aisen

OTHER

Sponsor Role: lead

Responsible Party

Paul S. Aisen

Director, ATRI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Adam Boxer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Keith Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital (MGH), Harvard Medical School

Central Contacts

ATP Recruitment and Retention (RER) Team

Role: CONTACT

adtau-participate@usc.edu

213-821-0569

Other Identifiers

R01AG078457

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ATRI-014-A

Identifier Type: -

Identifier Source: org_study_id