Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease
Conditions
Keywords
anti-amyloid mAb, monoclonal antibody (mAB), tau, amyloid
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 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.
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 donanemab, 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 1:1:1 ratio to either AADvac1 alone, combination AADvac1 therapy with donanemab, or donanemab alone (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.
Interventions
Sponsors
Paul S. Aisen
Axon Neuroscience SE
University of California, San Francisco
Massachusetts General Hospital
Alzheimer's Therapeutic Research Institute
Alzheimer's Clinical Trials Consortium
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).
Exclusion criteria
* No additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 donanemab, will produce a greater reduction in brain tau deposition as measured by 18F-MK-6240 PET compared to donanemab alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression as measured by plasma biomarkers | 30 months | To assess whether at least one tau therapy, either alone or in combination with donanemab, slows disease progression as measured by plasma biomarkers. |
Contacts
CONTACTATP Recruitment and Retention (RER) Team
PRINCIPAL_INVESTIGATORAdam Boxer, MD, PhD
University of California, San Francisco (UCSF), Memory and Aging Center
PRINCIPAL_INVESTIGATORKeith Johnson, MD
Massachusetts General Hospital (MGH), Harvard Medical School
Outcome results
None listed