Veri-T: A Trial of Verdiperstat in Patients With svPPA Due to TDP-43 Pathology
Trial Parameters
Brief Summary
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 Criteria
Inclusion Criteria: 1. Between 18 and 85 years of age (inclusive) at the initial screening visit; 2. Meets 2011 consensus criteria for svPPA (Gorno-Tempini et al. 2011); 3. MRI at screening is consistent with the underlying svPPA with no large strokes or severe white matter disease (Fazekas Grade ≤2; Fazekas et al. 1987); 4. CDR® plus NACC FTLD (Miyagawa et al. 2020) global score at screening ≤1; 5. The following medications are allowed, but must be stable for 2 months prior to the initial screening visit: 1. Food and Drug Administration (FDA)-approved Alzheimer's disease (AD) medications; 2. FDA-approved psychotropic medications; 6. Other medications (except those listed under exclusion criteria) are allowed as long as the dose is stable for 30 days prior to the initial screening visit; 7. Has a reliable study partner who agrees to accompany the participant to visits, and spends at least 5 hours per week with the participant; 8. Agrees to 2 LPs; 9. Signed and dated written informed co