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

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Senicapoc — DRUG
    10 mg oral tablet
  • Placebo Tablet — OTHER
    Placebo 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 Senicapoc
    10 mg daily Senicapoc for 52 weeks
  • Placebo Comparator: Placebo Group
    Placebo 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

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, Davis Alzheimer's Disease CenterSacramentoCalifornia95817
Martha Forloines, PhD
916-734-5223
UC Davis Alzheimer's Disease Center East BayWalnut CreekCalifornia94598
Martha Forloines, PhD
916-734-5223

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