Actively Recruiting

Phase 2
Age: 55Years - 85Years
All Genders
Healthy Volunteers
NCT04804241

Senicapoc in Alzheimer's Disease

Led by University of California, Davis · Updated on 2026-01-29

55

Participants Needed

2

Research Sites

219 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

A

Alzheimer's Drug Discovery Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Senicapoc in Alzheimer's Disease

Who Can Participate

Age: 55Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 55 to 85 years
  • Fluent in English or Spanish
  • Willing to be randomly assigned to receive 10 mg Senicapoc or placebo
  • Clinical Dementia Rating (CDR) global score of 0.5 or 1
  • Montreal Cognitive Assessment (MoCA) score between 12 and 28 at screening
  • Diagnosed with amnestic mild cognitive impairment or mild Alzheimer's disease dementia
  • Vision of at least 20/50 with or without correction
  • Have a study partner who has at least 6 hours of contact per week
  • For females of childbearing potential: agree to use highly effective contraception throughout the study until week 78 follow-up visit
Not Eligible

You will not qualify if you...

  • Unstable medical conditions including liver or kidney insufficiency
  • Unstable ischemic cardiovascular disease, respiratory failure, moderate to severe heart failure, cancer, unstable blood disorders, or life expectancy less than 3 years
  • Use of experimental Alzheimer's disease treatments
  • Unable to have MRI scan (due to pacemaker, implants, or severe claustrophobia)
  • History of chronic psychiatric illness, recent major depression, suicidal thoughts or attempts
  • Serious brain infections or head trauma causing lasting cognitive deficits
  • Alcohol or drug abuse within past 5 years
  • Known allergy to related compounds like clotrimazole
  • Poor venous access preventing multiple blood draws
  • Regular use of certain central nervous system medications unless approved and stable
  • Pregnant or breastfeeding females or planning pregnancy during the trial
  • Unable to swallow oral tablets
  • For cerebrospinal fluid sub-study: implanted shunt or catheter, bleeding disorders, recent anticoagulant or antiplatelet therapy, abnormal clotting labs
  • For PET sub-study: poor venous access, high recent radiation exposure, or low amyloid PET scan values

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of California, Davis Alzheimer's Disease Center

Sacramento, California, United States, 95817

Actively Recruiting

2

UC Davis Alzheimer's Disease Center East Bay

Walnut Creek, California, United States, 94598

Actively Recruiting

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Research Team

R

Rita Venua

CONTACT

S

Selene Leal Carrillo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Senicapoc in Alzheimer's Disease | DecenTrialz