Alzheimer's Tau Platform: Regimen A - AADvac1

Not Applicable

Not yet recruiting

• Conditions: Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Alzheimer Disease
• Interventions: Drug: AADvac1; Drug: Anti-amyloid Monoclonal Antibody (mAb)

• Registration Number: NCT07167966
• Lead Sponsor: Paul S. Aisen

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.

Study Timeline

• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-04
• Study First Posted: 2025-09-11
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-26
• Study Start: 2025-11-01
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 375

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AADvac1 monotherapy	AADvac1	Intravenous infusions of anti-amyloid mAb-matched placebo for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)
Anti-amyloid monoclonal antibody (mAb) active control	Anti-amyloid Monoclonal Antibody (mAb)	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).
Combination AADvac1 therapy with anti-amyloid monoclonal antibody (mAb)	AADvac1	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)
Combination AADvac1 therapy with anti-amyloid monoclonal antibody (mAb)	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)

Primary Outcome Measures

Name	Time	Method
Reduction of brain tau deposition as measured by tau positron emission tomography (PET)	0, 6, 18 and 30 months	To determine whether at least one tau therapy, either alone or in combination with an anti-amyloid mAb, will produce a greater reduction in brain tau deposition as measured by 18F-MK-6240 PET compared to anti-amyloid mAb alone.

Secondary Outcome Measures

Name	Time	Method
Disease progression as measured by plasma biomarkers	30 months	To assess whether at least one tau therapy, either alone or in combination with an anti-amyloid mAb slows disease progression as measured by plasma biomarkers.