Who is eligible for clinical trial NCT04804241?

Participants must meet the protocol's inclusion criteria for Mild Cognitive Impairment. The stated age range is 55 Years to 85 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04804241 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-14

Senicapoc in Alzheimer's Disease (NCT04804241)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of California, Davis

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (23 items).

Location: University of California, Davis Alzheimer's Disease Center — Sacramento, California

Age range: 55 Years to 85 Years

🧪 Interventions in This Study

Senicapoc (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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 made according to current research criteria. For patients referred from other clinics, the case will be reviewed by a study physician and neuropsychologist and only patients who satisfy criteria for probable AD (McKhann et al 1984) or amnestic MCI (Petersen et al 2004) will be eligible for enrollment.
Vision (with or without correction) of at least 20/50 for distant vision
All participants will need a study partner informant who has at least 6 hours of contact per week with the participant. The study partners are used to help answer questions on the subject's behalf, since many of them will be impaired and may need assistance with providing accurate information. The study partners are not asked to provide any opinions or judgements about the subjects.
For Females of childbearing potential: Must agree to practice a highly effective method of contraception throughout the study until completion of the Week 78 follow up visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of less than 1% per year when used correctly and consistently.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Unstable medical illnesses including hepatic insufficiency (elevated ALT, AST, or GGT; or low albumin attributable to liver disease), renal insufficiency (CK-EPI stage 4 or higher, or estimated GFR \<30)
Unstable ischemic cardiovascular disease, respiratory failure, moderate or severe congestive heart failure - New York Heart Association class III or IV, cancer, unstable hematologic disease or a life expectancy of \<3 years
Use of experimental AD treatments
Unable to undergo MRI scanning (e.g. pacemaker, metallic implants, severe claustrophobia)
History of chronic psychiatric illness (e.g. schizophrenia), any episode of major depression within last 2 years, or current Geriatric Depression Scale (GDS) \> 6, any recent suicide attempts or suicidal ideation. Subjects with a diagnosis of bipolar disorder may be included if they have been clinically stable for a minimum of 3 years prior to the Screening visit. Clinical stability to be determined by the Principal Investigator.
History of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis), head trauma resulting in any persistent cognitive deficit
History of alcohol or drug abuse/dependence within the past 5 years
Known allergy to chemically related compounds (e.g. clotrimazole)
Lack of good venous access, such that multiple blood draws would be precluded
Regular use of any of these CNS active medications: benzodiazepines, antipsychotics, narcotics, or anti-epileptic drugs. Exceptions may be allowed by the Principal Investigator for regular use of low doses of CNS active medications. Subjects using any of these treatments will be instructed to hold their dose on the evening prior and the day of the efficacy visits (Baseline, Week 26 and Week 52). Stable doses (\> 6 weeks) of cholinesterase inhibitors or memantine will be allowed, as will stable doses of anti-depressants.
Female subjects who are pregnant or breastfeeding or who plan to become pregnant during participation in this trial

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

University of California, Davis Alzheimer's Disease Center — Sacramento, California
UC Davis Alzheimer's Disease Center East Bay — Walnut Creek, California

📞 Contact the Study Coordinator

Phone: (916) 734-1708

Email: rmvenua@ucdavis.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses — Phoenix, Arizona
Remote Game-based Exercise Program for Cognitive and Motor Function Improvement — Los Angeles, California
IHT for Mild Cognitive Impairment — Fort Worth, Texas

Explore by condition: All Mild Cognitive Impairment clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗