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
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.
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).
Please go to ClinicalTrials.gov for more information.