Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06957418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alzheimer's Tau Platform: Master Protocol
Sponsor:
Paul S. Aisen
Organization:
Study Overview
Official Title:
The Alzheimer's Disease Tau Platform Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATP
Brief Summary:
The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with an anti-amyloid monoclonal antibody (mAb), 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 main questions the platform trial aims to answer are:
* Does any tau-directed therapy, alone or in combination with an anti-amyloid mAb, reduce brain tau deposition more than an anti-amyloid mAb, alone?
* Does any tau-directed therapy, alone or in combination with an anti-amyloid mAb, slow disease progression based on fluid biomarkers, imaging, or clinical measures?
Participants will:
* Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time.
* Receive an anti-amyloid mAb or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with an anti-amyloid mAb.
* Undergo regular cognitive testing, brain scans (MRI/PET), and biomarker assessments over 30 months
Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of an anti-amyloid mAb and tau therapy, or (3) an anti-amyloid mAb alone.
New regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available.
ATP is expected to launch with two regimens:
* Regimen A: AADvac1
* Regimen B: Tau2
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 main questions the platform trial aims to answer are:
* Does any tau-directed therapy, alone or in combination with an anti-amyloid mAb, reduce brain tau deposition more than an anti-amyloid mAb, alone?
* Does any tau-directed therapy, alone or in combination with an anti-amyloid mAb, slow disease progression based on fluid biomarkers, imaging, or clinical measures?
Participants will:
* Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time.
* Receive an anti-amyloid mAb or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with an anti-amyloid mAb.
* Undergo regular cognitive testing, brain scans (MRI/PET), and biomarker assessments over 30 months
Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of an anti-amyloid mAb and tau therapy, or (3) an anti-amyloid mAb alone.
New regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available.
ATP is expected to launch with two regimens:
* Regimen A: AADvac1
* Regimen B: Tau2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AG078457 | NIH | None | https://reporter.nih.gov/quic… | View |