NCT04804241 · University of California, Davis
Senicapoc in Alzheimer's Disease
(Senicapoc)
What this study is about
Development of novel disease-modifying therapies for Alzheimer's disease (AD) remains of paramount importance. This study will be a Phase II randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Senicapoc
10 mg oral tablet
OTHER
Placebo Tablet
Placebo Oral Tablet
Primary outcome measures
Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score
Time frame: Baseline, Week 26, Week 52
ADAS-Cog 13 is a scale used to measure cognitive dysfunction in a number of neural domains. Total scores range from 0-70, with higher scores indicating greater cognitive impairment and a worse outcome.
Change from Baseline to Week 52 in levels of Cerebrospinal fluid (CSF) biomarkers: IL-1β, IL-6, TNF-α, MCP-1, and IL-10
Time frame: Baseline, Week 52
A lumbar puncture will be done and CSF collected at baseline prior to initiating study treatment and at Week 52 at the end of study treatment
Change from Baseline to Week 52 in levels of serum biomarkers: IL-6, TNF-α, MCP-1, and IL-10 and high sensitivity C-Reactive protein
Time frame: Baseline, Week 52
Blood draws will be done and serum processed at baseline prior to initiating study treatment and at Week 52 at the end of study treatment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 wi
Where
- Sacramento, California
- Walnut Creek, California
Collaborators
Alzheimer's Drug Discovery Foundation, Alzheimer's Association, Biossil Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations