Senicapoc in Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Senicapoc
- Placebo Tablet
Treatment groups
55 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, Davis
Lead sponsor
Alzheimer's Drug Discovery Foundation
Collaborator
Alzheimer's Association
Collaborator
Biossil Inc.
Collaborator
Source ClinicalTrials.gov