This study is not yet accepting patients

Alzheimer's Tau Platform: Regimen A - AADvac1

a study on Alzheimer's Disease

Summary

Eligibility
for people ages 50-80 (full criteria)
Dates
study started
study ends around
Principal Investigator
by Adam Boxer, MD, PhD (ucsf)
Headshot of Adam Boxer
Adam Boxer

Description

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.

Official Title

Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1

Details

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.

Keywords

Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease, anti-amyloid mAb, monoclonal antibody (mAB), tau, amyloid, Pick Disease of the Brain, AADvac1, Anti-amyloid Monoclonal Antibody (mAb), AADvac1 monotherapy

Eligibility

You can join if…

Open to people ages 50-80

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

You CAN'T join if...

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

Lead Scientist at University of California Health

  • Adam Boxer, MD, PhD (ucsf)
    Adam L. Boxer, MD, PhD is the Endowed Professor in Memory and Aging in the Department of Neurology, Weill Institute of Neuroscience, University of California, San Francisco (UCSF). He received his MD and PhD from the New York University Medical Center Medical Scientist Training Program, completed a Neurology Residency at Stanford and a Neurobehavior Fellowship at UCSF.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Paul S. Aisen
ID
NCT07167966
Phase
Phase 2 Alzheimer's Disease Research Study
Study Type
Interventional
Participants
Expecting 375 study participants
Last Updated