NCT07217665

The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Adam Boxer · Academic / Other
• Sex: All
• Age: 41 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of PSP. Regimen A will evaluate the safety and efficacy of a single study drug, AADvac1, in participants with PSP.

Detailed description

The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The PTP Master Protocol is registered as NCT07173803. Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance to be randomized to all regimens that are active at the time of screening. If a participant is randomized to Regimen A: AADvac1, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active AADvac1 or matching placebo. 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 PTP Master Protocol under NCT07173803.

Conditions

• PSP - Progressive Supranuclear Palsy

Interventions

Type	Name	Description
BIOLOGICAL	AADvac1	AADvac1 administration: subcutaneous injection.
BIOLOGICAL	Matching Placebo	Matching placebo administration: subcutaneous injection.

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-07-31
• Completion: 2029-07-31
• First posted: 2025-10-16
• Last updated: 2025-10-16

Regulatory

• FDA-regulated drug study