A Phase 2 interventional study of AADvac1 and Donanemab in Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease and Alzheimer Disease, sponsored by Paul S. Aisen. Enrolling by invitation at 7 sites in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Paul S. Aisen · Phase 2, Interventional, and Treatment
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Among 15 studies testing donanemab in Alzheimer Disease — 7 open to participants now, 10 under way, 6 of them phase 3. donanemab · Alzheimer Disease.
Among the 15 studies testing donanemab in Alzheimer Disease, this one is the 5th largest by planned enrollment, is one of 7 that started in 2026, is one of 4 in phase 2, and was the 11th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →7 of the 15 studies testing donanemab in Alzheimer Disease are open now, in 8 countries. Recruiting first, the newest first:
Banner Health · Sites in Colombia
Ages 25–65 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Japan, Puerto Rico
Ages 55+
Eli Lilly and Company · Sites in United States, Japan, Korea, Republic of and 1 more country
Ages 55–85
Eli Lilly and Company · Sites in China
Ages 55–80
Eli Lilly and Company · Sites in India
Ages 60–85
By country, each count listing its studies:
donanemab: first FDA approval 2024 (KISUNLA), first EMA approval 2025. What it is approved for, and how studies give it, is on its page →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 50 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 7 · Phase 4 2
First in 2013; this study’s year is marked. 7 started in 2026.
This study's planned enrollment of 450 is above the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 240 across the 15 interventional studies. Of the 5 that completed or were terminated, 5 (100%) have results posted.
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12 of 15 have an industry lead sponsor. The 4 most frequent:
Paul S. Aisen is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Paul S. Aisen has 2 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
1 of the studies testing donanemab in Alzheimer Disease that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05026866Phase 3Eli Lilly and CompanyA Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) | 2027-11 |
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Among the 15 studies testing donanemab in Alzheimer Disease, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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Exclusion Criteria:
Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)
Drug: AADvac1
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)
Drug: AADvac1 · Drug: Donanemab
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).
Drug: Donanemab
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.
Time frame: 0, 6, 18 and 30 months
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.
Time frame: 30 months
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2028, 21 months later.
Of 127 non-industry phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 69. This study's planned 21 months is below that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drugs tested here: AADvac1 · Donanemab
Paul S. Aisen