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Senicapoc in Alzheimer's Disease

Study acronym: Senicapoc
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Jun 2026 → Dec 2027
See other at-risk trials from University of California, Davis

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 2026 to Dec 2027v16
  2. Primary completion date: Dec 2025 to Jun 2026v15
  3. Collaborators expanded, about 8 wordsv14
  4. Re-verified, no change to tracked fieldsv13
  5. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Jun 2025 to Jun 2026
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Eligibility criteria revisedv11
  2. Study description revisedv10
  3. Re-verified, no change to tracked fieldsv9
  4. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Dec 2022 to Dec 2024
    • Study sites: 0 to 2
    • Study completion date: Jun 2023 to Jun 2025
    • Start date changed from estimate of Mar 1, 2022 to Mar 18, 2022
  5. Start date: Jan 1, 2022 to Mar 1, 2022v7
  6. Start date: Nov 1, 2021 to Jan 1, 2022v6
  7. Start date: Sep 1, 2021 to Nov 1, 2021v5
  8. Start date: Jul 1, 2021 to Sep 1, 2021v4
  9. Study Status, Referencesv3
  10. Start date: May 2021 to Jul 1, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04804241
Lead Sponsor University of California, Davis
Collaborators: Alzheimer's Drug Discovery Foundation, Alzheimer's Association, Biossil Inc.
Conditions
(from sponsor)		 Mild Cognitive Impairment, Alzheimer Disease
Related terms Alzheimer Disease, Cognitive Dysfunction
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov