Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG078457 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Axon Neuroscience SE | INDUSTRY |
| University of California, San Francisco | OTHER |
| Massachusetts General Hospital | OTHER |
| Alzheimer's Therapeutic Research Institute |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AADvac1 monotherapy | Experimental | Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150) |
|
| Combination AADvac1 therapy with donanemab | Experimental | Intravenous infusions of donanemab for 6 months, combination donanemab and subcutaneous injections of AADvac1 for 6 months, followed by 18 months of AADvac1 injections alone (n = 150) |
|
| Donanemab active control | Active Comparator | Intravenous infusions of donanemab for 6 months, combination donanemab and AADvac1-matched placebo subcutaneous injections for 6 months, followed by 18 months of AADvac1-matched placebo injections alone (n = 150). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AADvac1 | Drug | Subcutaneous injection of AADvac1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of brain tau deposition as measured by tau positron emission tomography (PET) | 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. | 0, 6, 18 and 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression as measured by plasma biomarkers | To assess whether at least one tau therapy, either alone or in combination with donanemab, slows disease progression as measured by plasma biomarkers. | 30 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Boxer, MD, PhD | University of California, San Francisco (UCSF), Memory and Aging Center | Principal Investigator |
| Keith Johnson, MD | Massachusetts General Hospital (MGH), Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco (UCSF), Memory and Aging Center | San Francisco | California | 94158 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D020774 | Pick Disease of the Brain |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709631 | AADvac1 |
| C000729112 | donanemab |
Not provided
Not provided
Not provided
| OTHER |
| Alzheimer's Clinical Trials Consortium | OTHER |
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
| Donanemab | Drug | Active comparator: intravenous infusion of donanemab |
|
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D057180 | Frontotemporal Dementia |
| D057174 | Frontotemporal Lobar Degeneration |