Alzheimer's Tau Platform: Regimen A - AADvac1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AADvac1, Donanemab.
- Who it may be relevant to
- Registry conditions: Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1
Overview
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
- Drug AADvac1
Subcutaneous injection of AADvac1 - Drug Donanemab
Active comparator: intravenous infusion of donanemab
Primary outcome measures
- Reduction of brain tau deposition as measured by tau positron emission tomography (PET) [Time frame: 0, 6, 18 and 30 months]
Secondary outcome measures (1)
- Disease progression as measured by plasma biomarkers [Time frame: 30 months]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco (UCSF), Memory and Aging Center — San Francisco
Identifiers
NCT: NCT07167966 · ATRI-014-A · R01AG078457