drugset / Trial / NCT04804241
Senicapoc in Alzheimer's Disease
Phase 2
Recruiting
55 enrolled
University of California, Davis
Alzheimer's Association · collabAlzheimer's Drug Discovery Foundation · collabBiossil Inc. · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
Development of novel disease-modifying therapies for Alzheimer's disease (AD) remains of paramount importance. This study will be a Phase II randomized clinical trial testing Senicapoc in patients with mild or prodromal AD. This will be a small Proof of Mechanism study to prove biological activity and target engagement in humans with early AD. The investigators will study up to 55 patients over 52 weeks, with primary outcomes being Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) scores and blood and cerebrospinal fluid (CSF) markers of neuroinflammation. This pilot study will provide an estimate of treatment effect size on cognitive trajectory, daily function, and brain atrophy.
Timeline
- Start
- 2022-03-18
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Senicapoc | Small molecule | 10 mg | Oral |