Senicapoc in Alzheimer's Disease
Part of paid clinical trials in Sacramento, California.
- Sponsor
- University of California, Davis
- Study ID
- NCT04804241
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Mild Cognitive Impairment
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - 85 Years
- Healthy Volunteers
- Accepted
Interventions
- Senicapoc — DRUG10 mg oral tablet
- Placebo Tablet — OTHERPlacebo Oral Tablet
Study Details
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.
Key Dates
- Start date
- Mar 18, 2022
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 55 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: 10 mg daily Senicapoc10 mg daily Senicapoc for 52 weeks
- Placebo Comparator: Placebo GroupPlacebo daily for 52 weeks
Primary Outcome Measure
Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score [ Time Frame: Baseline, Week 26, Week 52 ]
Central Contacts
- Rita Venua(916) 734-1708
- Selene Leal Carrillo(925) 357-6914
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Davis Alzheimer's Disease Center | Sacramento | California | 95817 | |
| UC Davis Alzheimer's Disease Center East Bay | Walnut Creek | California | 94598 |
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