RecruitingPhase 2NCT04804241

Senicapoc in Alzheimer's Disease

Proof of Mechanism Study of Senicapoc in Mild or Prodromal Alzheimer's Disease

Sponsor

University of California, Davis

Enrollment

55 participants

Start Date

Mar 18, 2022

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Mild Cognitive Impairment

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.

Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called senicapoc in people with mild to moderate Alzheimer's disease, to see if it can slow memory loss and cognitive decline. Senicapoc works by affecting certain channels in brain cells that may play a role in the inflammation seen in Alzheimer's. **You may be eligible if...** - You are between 55 and 85 years old - You are fluent in English or Spanish - You have mild cognitive impairment or early Alzheimer's disease (based on standard memory tests) - You are willing to take either the drug or a placebo **You may NOT be eligible if...** - You have moderate to severe dementia - You are taking medications that would interact with senicapoc - You have significant other medical or psychiatric conditions - You are outside the specified age range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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