Proof of Mechanism Study of Senicapoc in Mild or Prodromal Alzheimer's Disease
University of California, Davis
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.
Description
The investigators will study up to 55 patients (8:3 active treatment with 10 mg/day maintenance dose: placebo) over 52 weeks in either the Sacramento or East Bay locations the University of California Davis Alzheimer's Disease Research Center (ADRC), with cognitive outcomes, blood, and CSF markers of neuroinflammation. This pilot study will provide an estimate of treatment effect size on cognitive trajectory, daily function, and brain atrophy. The trial will last 1 year (52 weeks on 10 mg/day of active drug or placebo) with primary efficacy measures at baseline, week 26, and week 52. Additiona…
Eligibility
- Age range
- 55–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 55-85 * Fluent in either English or Spanish * Willing to be randomized to active drug (10 mg Senicapoc) vs. placebo (3:1 ratio) * Clinical Dementia Rating (CDR) global score of 1 or 0.5 * Education adjusted scores between 12-28 on the Montreal Cognitive Assessment (MoCA) at the Screening visit. * A consensus clinical diagnosis of either amnestic Mild Cognitive Impairment (MCI) or mild AD dementia. Diagnoses are made by a comprehensive case conference review for all participants in the ADRC longitudinal cohort and all CADC referrals, resulting in a consensus diagnosis…
Interventions
- DrugSenicapoc
10 mg oral tablet
- OtherPlacebo Tablet
Placebo Oral Tablet
Locations (2)
- University of California, Davis Alzheimer's Disease CenterSacramento, California
- UC Davis Alzheimer's Disease Center East BayWalnut Creek, California