RecruitingPhase 2

Senicapoc in Alzheimer's Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks
  • Procedures mentioned: Heart tracing (ECG), Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The investigators will study up to 55 patients (8:3 active treatment with 10 mg/day maintenance dose: placebo) over 52 weeks in either the Sacramento or East Bay locations the University of California Davis Alzheimer's Disease Research Center (ADRC), with cognitive outcomes, blood, and CSF markers of neuroinflammation."
  • "Additional safety monitoring visits will occur at weeks 4, 12, and 36 including physical exams, measurement of blood pressure, vital signs, safety labs, electrocardiogram recordings, collection of Adverse Events and Concomitant Medications."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Senicapoc in people ages 55–85 with mild Alzheimer's disease or early memory problems linked to Alzheimer's. It will study up to 55 people for 52 weeks to see how the drug affects memory, thinking, and signs of swelling in the brain. People will be assigned by chance to take Senicapoc or a placebo, a pill with no active drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 55–85 years old and speak English or Spanish fluently.
  • Agree to take either 10 mg of Senicapoc or a placebo, chosen by chance. The chance of getting Senicapoc is 3 out of 4.
  • Have mild Alzheimer's dementia or mild memory loss confirmed by the study's clinical review.
  • Have a Clinical Dementia Rating of 0.5 or 1 and a MoCA thinking test score of 12–28, adjusted for education.
  • Have distance vision of 20/50 or better, with glasses or contacts if needed.
  • Have a study partner who spends at least 6 hours a week with you and can help answer questions.
  • If able to become pregnant, agree to use highly effective birth control through the week 78 follow-up visit.

Who can't join

  • Have certain serious or unstable illnesses, including liver, kidney, heart, lung, or blood problems; cancer; or an expected lifespan under 3 years.
  • Have a long-term mental illness, major depression in the past 2 years, a depression test score above 6, or recent suicidal thoughts or attempts. Stable bipolar disorder may be allowed after at least 3 years.
  • Have had a serious brain infection, a head injury with lasting thinking problems, or alcohol or drug abuse or dependence within the past 5 years.
  • Use experimental Alzheimer's treatments or regularly take certain sedatives, antipsychotics, strong pain medicines, or seizure medicines. Some low-dose exceptions are allowed. Stable doses of approved Alzheimer's medicines and antidepressants may be allowed.
  • Cannot have an MRI scan, have veins that make repeated blood draws impossible, cannot swallow tablets, or have an allergy to related drugs such as clotrimazole.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • For the spinal fluid sub-study: have certain implanted drainage tubes, bleeding problems, low blood platelets, abnormal blood-clotting tests, or recent use of certain blood thinners. Some medicine and platelet-count exceptions apply.
  • For the PET scan sub-study: cannot have repeated blood draws, had radiation exposure above 2 rem in the past 12 months, or have probable Alzheimer's dementia with a brain scan SUVr measurement below 1.08.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

CA