Veri-T: A Trial of Verdiperstat in Patients with svPPA Due to TDP-43 Pathology

  • Study Director: Peter Ljubenkov, MD
  • Collaborators: National Institutes of Health (NIH), Alzheimer's Association, National Institute on Aging (NIA)
  • Status: Not yet recruiting
  • Official Study Title: Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Oral Verdiperstat (BHV-3241) in Patients With Semantic Variant Primary Progressive Aphasia (svPPA) Due to TDP-43 Pathology
  • ClinicalTrials.gov Identifier: NCT05184569
  • Conditions Studied: Semantic variant primary progressive aphasia (svPPA)
  • Intervention: Verdiperstat
  • Phase: Phase 1
  • Duration of Participation: Up to 34 weeks including the screening period

Purpose of the Study

The purpose of the study is to test the safety and tolerability of twice-daily Verdiperstat in patients with semantic variant primary progressive aphasia (svPPA) due to frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP). Three-fourths of the participants will receive Verdiperstat and one-fourth will receive placebo during the 24-week treatment duration.

Eligibility

What to Expect

Testing: Neurological and physical examinations, MRIs, at least two lumbar punctures, cognitive testing and neuropsychiatric assessments, EKGs, telephone calls, blood and urine specimen collection, and vital signs

The Frequency of Visits: Every 4 weeks

Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a diagnosis of probable semantic variant primary progressive aphasia (svPPA) due to frontotemporal lobar degeneration with TDP-43 pathology (FTLD-TDP).

Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits.

Contact Information

Coordinator: Tayler Sulse[email protected], 415.514.5745
Clinical Trials Nurse: Mary Koestler, RN, PhD, CCRC[email protected], 415.476.0661