← Trials/Trial dossier/NCT04804241

Senicapoc

RecruitingPhase 2

Senicapoc in Alzheimer's Disease

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

Lead sponsor

University of California, Davis

Asset

Senicapoc

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•mild AD dementia•CDR global 1•MoCA 12-28

Primary endpoints

•ADAS-Cog•Levels of Cerebrospinal fluid (CSF) biomarkers•Levels of serum biomarkers

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID945869

NCT IDNCT04804241

Timeline

Milestones

Study first posted2021-03-18actual

Study start2022-03-18actual

Last update posted2026-01-29actual

Primary completion2026-06estimated (month precision)

Study completion2026-06estimated (month precision)

Assets

Drug assets

Senicapoc

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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

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

•Inability to swallow oral tablets

Exclusions for Cerebrospinal Fluid (CSF) Sub-study:

•Presence of an implanted shunt for the drainage of CSF or an implanted CNS catheter

•History of bleeding diathesis or coagulopathy,

•On anticoagulant therapy (within 14 days of lumbar puncture (LP), including but not limited to warfarin, heparin, dabigatran, rivaroxaban, and apixaban,

•Requires daily antiplatelet therapy, including but not limited to aspirin (unless < 81mg/day), clopidogrel, dipyridamole, and ticlopiidinegrel. However, the investigators will not exclude those who can safely hold antiplatelet therapy for 7 days prior to LP. Safety will be determined by the participant's Primary Care Provider and study PI.

•For those who take antiplatelet therapy intermittently (e.g. aspirin as needed for pain), the investigators will exclude any doses within 48 hours of the LP or more than two dosses within 7 days of LP.

•platelet count less than the lower limit of normal (platelet counts between 100,000 and 150,000 mm3 are permissible as long as the investigator confirms there is no evidence of current bleeding diathesis or coagulopathy)

•The investigators will require INR/PT and aPTT labs to be done within 14 days of LP and will exclude those with INR > 1.30 or abnormally elevated aPTT.

Exclusions for PET Sub-Study:

•Does not have good venous access, such that multiple blood draws would be precluded

•Prior radiation exposure of > 2 rem total within last 12 months.

•Probable AD dementia patients with a global cortical SUVr < 1.08.

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Executive function / language

Neuroimaging

Memory

Amyloid biomarkers

Fluid / digital biomarkers

Global cognition

3 endpoints

Primary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

Change from Screening in the Clinical Dementia Rating (CDR) sum of boxes score

Time frame:Screening, Week 26, Week 52

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/protocol endpoint

Change from Screening in Montreal Cognitive Assessment (MoCA) score

Time frame:Screening, Week 26, Week 52

Montreal Cognitive Assessment (MoCA)

descriptive

Memory

2 endpoints

Secondary/protocol endpoint

Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) memory score

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Bushcke Cued Selective Reminding Task (CSRT) score

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Executive function / language

3 endpoints

Secondary/protocol endpoint

Change from Baseline in Trails B score

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Verbal fluency (semantic) score

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Verbal fluency (letter) score

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Change from Baseline to Week 52 in total grey matter florbetaben binding on amyloid Positron Emission Tomography (PET)

Time frame:Baseline, Week 52

change from baseline, improvement

Neuroimaging

3 endpoints

Secondary/protocol endpoint

Change from Baseline to Week 52 in Brain MRI measures of total grey matter.

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Brain MRI measures of total brain volume.

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 52 in Brain MRI measures of white matter hyperintensities.

Time frame:Baseline, Week 52

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Primary/protocol endpoint

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

change from baseline, improvement

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in the Everyday Cognition (ECog) score

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) executive composite score

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Cognitive Event Related Potential (ERP) measures of P600 word repetition.

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Cognitive Event Related Potential (ERP) measures of alpha suppression effect.

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Cognitive Event Related Potential (ERP) measures of anti-coupling between early theta and late alpha/beta activity.

Time frame:Baseline, Week 26, Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.