We are recruiting patients for the PTP ATRI-015 study
The PSP Clinical Trial Platform (PTP) study is a multicenter, multi-regimen, Phase 2, randomized, double-blind, placebo-controlled, perpetual platform clinical trial, designed to evaluate the safety and efficacy of multiple investigational products simultaneously or sequentially in mild-to moderate Progressive Supranuclear Palsy (PSP).
The primary objective of this study is to evaluate the efficacy of multiple investigational products on PSP disease progression and determine whether the investigational products are safe and well-tolerated in participants with mild-to-moderate PSP. The primary endpoint is the change from baseline on the mPSPRS-15 over 52 weeks.
Investigational products will be tested in regimens. Each regimen will consist of an investigational product and a placebo. Approximately 440 participants will be enrolled across approximately 50 clinical sites in North America.
Who is eligible?
We are looking for people who are 41-86 and have:
- Clinical diagnosis of possible or probable PSP Richardson’s Syndrome phenotype defined by the 2017 MDS criteria with presence of PSP symptoms less than 5 years onset.
- MMSE score of 25 or less.
- A reliable study partner who spends sufficient time with the participant, and is willing and able to attend study visits and answer questions.
And those who have not have:
- Blood transfusion within 4 weeks of screening.
- Prior or current treatment with either anti-tau or anti-amyloid agents
- History of immunodeficiency disorders and autoimmune diseases that may require immunomodulatory medications.
What is involved?
- Three different treatment groups. All participants are randomized into a possible treatment or placebo group.
- Approximately 52-week double-blinded treatment period with an optional 52-week Open Label Extension.
- In-clinic visits every 4 weeks.
For more information, please contact the PSP Study Team:
Study Coordinator: Bailey Wolf, 253-266-5505 or bwolf3@uw.edu
Principal Investigator: Michael Rosenbloom
