The Progressive Supranuclear Palsy Clinical Trial Platform
Adam Boxer
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.
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. In this trial, multiple investigational products for PSP will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen. The additional details that govern the testing of each investigational product will be s…
Eligibility
- Age range
- 41–86 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Clinical diagnosis of possible or probable PSP Richardson's Syndrome as defined by the 2017 Movement Disorder Society (MDS) criteria. 2. Presence of PSP symptoms for ≤5 years at screening (based on the best judgment of the site PI). 3. Mini-Mental State Examination (MMSE) score at screening of ≥25. 4. Able to walk at least 10 steps with minimal assistance (e.g., one arm for safety, but not postural support). 5. Stable doses of permitted medications as described per protocol for 30 days prior to screening. 6. Resides at home or in the community (assisted living is accept…
Interventions
- BiologicalAADvac1
Active immunotherapy
- DrugLM11A-31
Small molecule
Location
- University of California, San FranciscoSan Francisco, California