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Senicapoc in Alzheimer's Disease

NCT04804241 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Senicapoc

10 mg oral tablet

OTHER

Placebo Tablet

Placebo Oral Tablet

Sponsors & Collaborators

  • Alzheimer's Drug Discovery Foundation

    collaborator OTHER

  • Alzheimer's Association

    collaborator OTHER

  • Biossil Inc.

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • John Olichney, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804241 on ClinicalTrials.gov