Senicapoc for Mild Cognitive Impairment (MCI)

1
Effectiveness
2
Safety
UC Davis Alzheimer's Disease Center East Bay, Walnut Creek, CA
+2 More
Senicapoc - Drug
Eligibility
18+
All Sexes
Eligible conditions
Mild Cognitive Impairment (MCI)

Study Summary

Senicapoc in Alzheimer's Disease

See full description

Eligible Conditions

  • Alzheimer Disease
  • Cognitive Decline
  • Mild Cognitive Impairment (MCI)
  • Cognitive Dysfunction

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Senicapoc will improve 3 primary outcomes and 16 secondary outcomes in patients with Mild Cognitive Impairment (MCI). Measurement will happen over the course of Baseline, Week 52.

Week 52
Change from Baseline in Bushcke Cued Selective Reminding Task (CSRT) score
Change from Baseline in Cognitive Event Related Potential (ERP) measures of P600 word repetition.
Change from Baseline in Cognitive Event Related Potential (ERP) measures of alpha suppression effect.
Change from Baseline in Cognitive Event Related Potential (ERP) measures of anti-coupling between early theta and late alpha/beta activity.
Change from Baseline in Trails B score
Change from Baseline in Verbal fluency (letter) score
Change from Baseline in Verbal fluency (semantic) score
Change from Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog 13) score
Change from Baseline in the Everyday Cognition (ECog) score
Baseline, Week 52
Change from Baseline to Week 52 in Brain MRI measures of total brain volume.
Change from Baseline to Week 52 in Brain MRI measures of total grey matter.
Change from Baseline to Week 52 in Brain MRI measures of white matter hyperintensities.
Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) executive composite score
Change from Baseline to Week 52 in Spanish English Neuropsychological Assessment Scales (SENAS) memory score
Change from Baseline to Week 52 in levels of Cerebrospinal fluid (CSF) biomarkers: IL-1β, IL-6, TNF-α, MCP-1, and IL-10
Change from Baseline to Week 52 in levels of serum biomarkers: IL-6, TNF-α, MCP-1, and IL-10 and high sensitivity C-Reactive protein
Change from Baseline to Week 52 in total grey matter florbetaben binding on amyloid Positron Emission Tomography (PET)
Week 52
Change from Screening in Montreal Cognitive Assessment (MoCA) score
Change from Screening in the Clinical Dementia Rating (CDR) sum of boxes score

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Placebo Group
10 mg daily Senicapoc
Placebo group

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Senicapoc is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

10 mg daily Senicapoc
Drug
10 mg daily Senicapoc for 52 weeks
Placebo Group
Other
Placebo daily for 52 weeks

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 26, week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, week 26, week 52 for reporting.

Closest Location

UC Davis Alzheimer's Disease Center East Bay - Walnut Creek, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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 15-28 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.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get mild cognitive impairment (mci) a year in the United States?

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While the American Psychological Association no longer considers MCI to be a form of dementia, the mci prevalence is comparable to or higher than the prevalence of MCI-I in the general population. While the American Psychological Association no longer considers MCI to be a form of dementia, the mci prevalence is comparable to or higher than the prevalence of MCI-I in the general population. While the American Psychological Association no longer considers MCI to be a form of dementia, the mci prevalence is comparable to or higher than the prevalence of MCI-I and MCI-H in the general population.

Unverified Answer

Can mild cognitive impairment (mci) be cured?

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The current studies suggest that mci is not a permanent or even long term condition that cannot be cured. Better understanding of the heterogeneity of MCI will contribute to a more specific characterization, better treatment, and improved health-related outcomes.

Unverified Answer

What are the signs of mild cognitive impairment (mci)?

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Some signs of mild cognitive impairment (mci) include confusion, disorientation, and not remembering how to do things. Other signs include memory and attention problems. Other signs of mci could include trouble sleeping, restless legs, and trouble controlling the eyes. If symptoms are serious, a doctor or family doctor can administer a dementia screening test.\n

Unverified Answer

What is mild cognitive impairment (mci)?

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mci has distinct clinical, neuropsychological and neuroimaging characteristics from MCI. mci is associated with more rapid and sustained neuropsychological decline than MCI. The development of MTS is an independent factor of dementia. The diagnostic utility of MTS should be further investigated especially for early detection of dementia/MCI.

Unverified Answer

What causes mild cognitive impairment (mci)?

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It is difficult to say the exact cause of MCI and it can't necessarily be found by screening. Some factors that increases the risk of getting MCI include obesity, alcohol/tobacco/drug use, viral infections causing acute inflammatory brain damage, immunological defects, brain damage from stroke or traumatic brain injury, some autoimmune, neurodegenerative, inflammatory/inflammatory neurodegenerative and neurovascular disorders. However, some of these possible causes may have common causal factors such as viral infections or immune system dysfunction.

Unverified Answer

What are common treatments for mild cognitive impairment (mci)?

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For older adults, cognitively intact people, treatments that help maintain and even improve cognition are critical. Some commonly used treatments have been shown to have the strongest evidence for their benefits, while others have strong benefit but weaker evidence. In the absence of good evidence, this review will highlight a range of treatments, based on the type of treatment and the individual patient. The focus of this review is on drugs and therapies with proven benefit, and only as a general guide; there is still a need for high quality clinical research that could help clarify the most effective treatment for older people with mci.

Unverified Answer

What is the primary cause of mild cognitive impairment (mci)?

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Findings from a recent study suggest that deficits in executive functions make a large contribution to early stage mci patients. Cognitively normal individuals with mild mci are also more likely to suffer from severe impairments in executive functions than healthy controls. Reduced executive functioning in mci correlates with age, schooling, and employment history. Findings from a recent study of the correlation analyses between patient and control groups show that executive deficiencies increase the risk of developing cognitive deficits. Executive defects in mci correlate with increased executive difficulties and increased severity of the executive deficits, such as reduced efficiency in the inhibition of inappropriate responses.

Unverified Answer

Is senicapoc safe for people?

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Results from a recent paper, of people with mild to moderately severe cognitive impairment and age >75, the medication did not result in a clinically important increase in deaths or hospitalisations. Senicapoc does not have an increased risk of dementia or agitation.

Unverified Answer

How serious can mild cognitive impairment (mci) be?

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Mild cognitive impairment (mci) is associated with an increase of disability and an impact on patients' social life of daily living, as well as an increase in the need for a caregiver.

Unverified Answer

What are the common side effects of senicapoc?

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About 60% of patients experienced [sudden hearing loss] side effects. Because patients with [older] age or [more] severe medical conditions were more likely to experience such [side effects], clinicians should more often consider a [hearing test] when [observing a patient].

Unverified Answer

Does mild cognitive impairment (mci) run in families?

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In families with an mci diagnosis, the risk of having a diagnosis of Alzheimer's disease is approximately three times increased per affected level. In families with an affected spouse, the risk for an affected child is approximately one and a half times increased. Thus, if there is an mci diagnosis in an affected family member, it may be prudent to consider a family history of Alzheimer's disease for that affected person and, if indicated, arrange clinical testing.

Unverified Answer

How does senicapoc work?

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Findings from a recent study indicate that senicapoc's effectiveness and tolerability in treating AD is similar to that observed with placebo. Findings from a recent study do not indicate any specific reason why senicapoc treatment is ineffective or safe in AD patients.

Unverified Answer
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