Alzheimer Disease / Mild Cognitive Impairment / Senicapoc · Phase 2 Trial

Senicapoc in Alzheimer's Disease

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 proof-of-mechanism trial registration (not yet reporting results) of senicapoc in mild cognitive impairment and prodromal Alzheimer disease. The study aims to establish biological activity and target engagement through inflammatory biomarkers and cognitive decline measures over 52 weeks in approximately 55 participants. Results are not yet available in this registry entry.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Other purpose. Mild Cognitive Impairment, Alzheimer Disease; age from 55 Years; to 85 Years; accepts healthy volunteers. Intervention: 10 mg daily Senicapoc. Compared with: Placebo Group — Placebo Comparator. n = 55. 2 sites: United States.

Key findings

Safety

This is a registry record with no results reported; all claims about efficacy, safety, or effect size are premature.

Who this may help

This trial is at an early stage and designed to establish whether senicapoc engages its target and shows biological activity in early AD. Clinical utility cannot be assessed until results are published and demonstrate cognitive or functional benefit beyond inflammatory biomarker changes.

Plain-language summary

A Phase 2 proof-of-mechanism trial in early-stage Alzheimer disease with surrogate inflammatory and cognitive endpoints; results not yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score (assessed at Baseline, Week 26, Week 52); Change from Baseline to Week 52 in levels of Cerebrospinal fluid (CSF) biomarkers: IL-1β, IL-6, TNF-α, MCP-1, and IL-10 (assessed at Baseline, Week 52); 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 (assessed at Baseline, Week 52)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Other purpose

PopulationMild Cognitive Impairment, Alzheimer Disease; age from 55 Years; to 85 Years; accepts healthy volunteers

Sample size55

Intervention10 mg daily Senicapoc

ComparatorPlacebo Group — Placebo Comparator

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size55

Study phasePhase 2

Primary outcome: cognitive endpointADAS-Cog 13 score change from baseline to Week 26 and Week 52

Primary outcome: CSF biomarkersIL-1β, IL-6, TNF-α, MCP-1, IL-10 change from baseline to Week 52

Primary outcome: serum biomarkersIL-6, TNF-α, MCP-1, IL-10, high sensitivity C-Reactive protein change from baseline to Week 52

Follow-up duration52 weeks

Clinical bottom line

Caveats

This is a registry record with no results reported; all claims about efficacy, safety, or effect size are premature.
Study is explicitly described as 'small' and a 'pilot'; powered for proof-of-mechanism, not for definitive efficacy claims.
Primary outcomes include surrogate biomarkers (CSF and serum inflammatory markers); cognitive decline (ADAS-Cog) is also measured but results are unknown.
No sample size justification, effect size estimates, or interim analyses are reported in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 randomized controlled trial with placebo comparator, but small and proof-of-mechanism focused.

Directness

moderate

Cognitive and biomarker endpoints; cognitive outcomes directly relevant but biomarkers are surrogate.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

moderate

Randomized and placebo-controlled design, but small sample limits generalizability of findings.

Sample adequacy

limited

Estimated enrollment 55 participants total; explicitly a small pilot proof-of-mechanism study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04804241). This is a study registration, not published results. Lead sponsor: University of California, Davis. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 55 participants (ESTIMATED). Conditions: Mild Cognitive Impairment, Alzheimer Disease. Interventions: DRUG: Senicapoc; OTHER: Placebo Tablet. Primary outcome measures: Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score , Baseline, Week 26, Week 52; Change from Baseline to Week 52 in levels of Cerebrospinal fluid (CSF) biomarkers: IL-1β, IL-6, TNF-α, MCP-1, and IL-10 , Baseline, Week 52; 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 , Baseline, Week 52. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alzheimer DiseaseUniversity of California, DavisNCT04804241Mild Cognitive ImpairmentSenicapoc