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New treatment option for Mild Cognitive Impairment
Official title Senicapoc in Alzheimer's Disease
ClinicalTrials.gov ID: NCT04804241
What this study is testing
What is Senicapoc?
Senicapoc is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mild cognitive impairment.
Also referred to as TRAM-34.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Age 55-85
- Fluent in either English or Spanish
- Willing to be assigned by chance 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.
You likely can't join if
- Unstable medical illnesses including hepatic insufficiency (elevated ALT, AST, or GGT; or low albumin attributable to liver disease), renal...
- Unstable ischemic cardiovascular disease, respiratory failure, moderate or severe congestive heart failure - New York Heart Association class III or...
- 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...
- History of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis), head trauma resulting in any...
See the full eligibility criteria
- Age 55-85
- Fluent in either English or Spanish
- Willing to be assigned by chance 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Female people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Walnut Creek, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Walnut Creek, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.