Preclinical Alzheimer's DiseasePhase 2ATPNCT07167966
Alzheimer's Tau Platform: Regimen A - AADvac1
A Phase 2 study testing AADvac1 and Donanemab in people with Preclinical Alzheimer's Disease and Prodromal Alzheimer's Disease, run by Paul S. Aisen at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer Disease
- What is being tested?
- AADvac1 and Donanemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Nov 2026to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).
Who cannot join
- No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol (NCT06957418).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Brigham and Women's Hospital, Center for Alzheimer's Research and Treatment
Boston, Massachusetts, 02115
University of Kentucky Sanders Brown Center on Aging
Lexington, Kentucky, 40504
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Butler Hospital Memory and Aging Program
Providence, Rhode Island, 02906
University of California, San Francisco (UCSF), Memory and Aging Center
San Francisco, California, 94158
Harborview Medical Center, University of Washington
Seattle, Washington, 98104
About this study
Official title: Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1
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.
Read the 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.
- Being tested
- AADvac1, Donanemab
- Keywords
- anti-amyloid mAb, monoclonal antibody (mAB), tau, amyloid
- Medical subject headings
- Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AADvac1Drug
Subcutaneous injection of AADvac1
DonanemabDrug
Also called Kisunla
Active comparator: intravenous infusion of donanemab
| Study group | Role | What they receive |
|---|---|---|
| AADvac1 monotherapy | Experimental | Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150) Receives: Drug: AADvac1 |
| 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) Receives: Drug: AADvac1; Drug: Donanemab |
| 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). Receives: Drug: Donanemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6, 18 and 30 months
Secondary outcomes (1)
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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start3 Nov 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preclinical Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul S. Aisen
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Sponsor-investigator, Paul S. Aisen, University of Southern California
- Investigators
- Adam Boxer, MD, PhD, Principal investigator, University of California, San Francisco (UCSF), Memory and Aging CenterKeith Johnson, MD, Principal investigator, Massachusetts General Hospital (MGH), Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167966
- Sponsor's protocol ID
- ATRI-014-A
- Other IDs
- R01AG078457
- Acronym
- ATP
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1
- ClinicalTrials.gov ID
- NCT07167966
- Acronym / sponsor ID
- ATP / ATRI-014-A
- Keywords
- anti-amyloid mAb, monoclonal antibody (mAB), tau, amyloid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Paul S. AisenUniversity, hospital or other
- Collaborators
- 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 start
- 3 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AADvac1 monotherapy | Experimental | Drug: AADvac1Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150) |
| Combination AADvac1 therapy with donanemab | Experimental | Drug: AADvac1, Drug: DonanemabIntravenous 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 | Drug: DonanemabIntravenous 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). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).
Key exclusion criteria (1 listed)
- No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol (NCT06957418).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AADvac1Subcutaneous injection of AADvac1 | Drug | AADvac1 monotherapy, Combination AADvac1 therapy with donanemab |
| DonanemabAlso: KisunlaActive comparator: intravenous infusion of donanemab | Drug | Combination AADvac1 therapy with donanemab, Donanemab active control |
Primary outcome
Reduction of brain tau deposition as measured by tau positron emission tomography (PET)
Time frame: 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.
1 secondary outcome
Disease progression as measured by plasma biomarkers
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Boxer, MD, PhD principal investigator
University of California, San Francisco (UCSF), Memory and Aging Center
Keith Johnson, MD principal investigator
Massachusetts General Hospital (MGH), Harvard Medical School
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AADvac1 and Donanemab in people with Preclinical Alzheimer's Disease and Prodromal Alzheimer's Disease, run by Paul S. Aisen at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of brain tau deposition as measured by tau positron emission tomography (PET) (time frame: 0, 6, 18 and 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.