Alzheimer's Tau Platform: Regimen A - AADvac1 (ATP)

Paul S. Aisen

Status and phase: Not yet enrolling; Phase 2

Conditions: Alzheimer Disease; Prodromal Alzheimer's Disease; Preclinical Alzheimer's Disease

Treatments: Drug: Anti-amyloid Monoclonal Antibody (mAb); Drug: AADvac1

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07167966

R01AG078457 (U.S. NIH Grant/Contract)

ATRI-014-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 3 patient groups

AADvac1 monotherapy

Experimental group

Description:

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

Treatment:

Drug: AADvac1

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

Experimental group

Description:

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)

Treatment:

Drug: AADvac1

Drug: Anti-amyloid Monoclonal Antibody (mAb)

Anti-amyloid monoclonal antibody (mAb) active control

Active Comparator group

Description:

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).

Treatment:

Drug: Anti-amyloid Monoclonal Antibody (mAb)