NCT04804241 Senicapoc in Alzheimer's Disease
| NCT ID | NCT04804241 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Davis |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2022-03-18 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2022-03-18 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
John Olichney, MD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT04804241 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 85 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04804241 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04804241 currently recruiting?
Yes, NCT04804241 is actively recruiting participants. Contact the research team at rmvenua@ucdavis.edu for enrollment information.
Where is the NCT04804241 trial being conducted?
This trial is being conducted at Sacramento, United States, Walnut Creek, United States.
Who is sponsoring the NCT04804241 clinical trial?
NCT04804241 is sponsored by University of California, Davis. The principal investigator is John Olichney, MD at University of California, Davis. The trial plans to enroll 55 participants.