Progressive Supranuclear Palsy Trial of Oral Salsalate

  • Study Director: Adam Boxer, MD, PhD
  • Sponsor: Tau Consortium
  • Recruiting? Yes
  • Official Study Title: A 6-Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy
  • ClinicalTrials.gov Identifier: NCT02422485
  • Conditions Studied: Progressive supranuclear palsy (PSP)
  • Intervention: Salsalate will be administered orally twice daily for 6 months. Salsalate has been marketed for decades in the US as a prescription drug for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and related rheumatic disorders, but this is the first time salsalate will be studied in people with PSP.
  • Phase: Phase 1
  • Duration of Participation: Approximately 10 visits in 7½ months

Purpose of the Study

The purpose of this study is to determine the safety and tolerability of oral salsalate in people with PSP.

Eligibility

Inclusion Criteria: Subjects must be between 50–85 years of age (inclusive). Subjects must also have a Mini Mental State Examination (MMSE) score of 14–30 at the screening visit. Subjects must be willing and able to have three brain MRIs as well as two lumbar punctures performed. Subjects must have a reliable caregiver who has at least five hours of contact with them per week and is willing to accompany the subject to study visits. Subjects must have stable medications for two months prior to screening.

Exclusion Criteria: Subjects must not have any medical condition other than PSP that could account for cognitive deficits (such as Alzheimer’s disease, active seizure disorder, stroke or vascular dementia). Subjects must not have a prominent and sustained response to levodopa therapy. Subjects must not have a history of significant cardiovascular, hematologic, renal, or hepatic disease, major psychiatric illness or untreated depression. Subjects must not use non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates chronically (except 81 mg daily baby aspirin). Subjects must not be taking thiazides, loop diuretics, oral corticosteroids, or angiotensin-converting enzyme (ACE) inhibitors. Subjects must not have participated in another interventional clinical trial within 3 months of screening.

What to Expect

Testing: Three brain MRIs, two lumbar punctures, neurological and physical examinations, cognitive testing and neuropsychiatric assessments, ECGs, blood and urine specimen collection, vital signs, eye movement testing and actigraphy measurements (wearing a device around your wrist to monitor your movements)

The Frequency of Visits:

  • Screening phase: 2 visits and one week of actigraphy within 28 days of first dose
  • Dosing administration phase: Monthly visits for 6 months
  • Follow-up: One follow-up visit within one week of the last dose of salsalate followed by one week of actigraphy

Materials Needed Before Evaluation: Participants meet criteria for probable or possible PSP (based on the National Institute of Neurological Disorders & Stroke and The Society for Progressive Supranuclear Palsy).

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits, and subjects will be reimbursed $75 for each scheduled visit and $50 for additional MRI scanning and/or lumbar puncture visits to help defray any incidental expenses incurred in the course of participating in this study.

Contact Information

Coordinator: Megan Frank – Megan.Frank@ucsf.edu, 415.476.0671​
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC – Mary.Koestler@ucsf.edu, 415.476.0661