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Ion Channel Blocker
Senicapoc for Alzheimer's Disease (Senicapoc Trial)
Phase 2
Recruiting
Led By John Olichney, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 55-85
Consensus clinical diagnosis of either amnestic Mild Cognitive Impairment (MCI) or mild AD dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 26, week 52
Awards & highlights
Senicapoc Trial Summary
This trial will test a new drug, Senicapoc, on patients with early Alzheimer's disease to see if it can improve cognitive function and slow brain atrophy.
Who is the study for?
This trial is for people aged 55-85 with early Alzheimer's or mild cognitive impairment, fluent in English/Spanish, and have a study partner. Women must use contraception if of childbearing potential. Exclusions include pregnancy, difficulty swallowing pills, recent high radiation exposure, inability to undergo MRI scans, unstable medical conditions like severe heart failure or renal insufficiency, psychiatric illness history including major depression within the last two years.Check my eligibility
What is being tested?
The trial tests Senicapoc against a placebo in patients with mild Alzheimer's over one year. It aims to see if Senicapoc can improve cognition and reduce neuroinflammation by measuring changes in ADAS-Cog scores and inflammatory markers in blood/CSF.See study design
What are the potential side effects?
While specific side effects are not listed here for Senicapoc as it is under investigation, common drug-related side effects could include gastrointestinal issues (nausea/vomiting), headaches, dizziness or allergic reactions.
Senicapoc Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 55 and 85 years old.
Select...
I have been diagnosed with early memory loss or mild Alzheimer's disease.
Senicapoc Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 26, week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 26, week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alzheimer's Disease
Cerebrospinal fluid shunts procedure
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
Secondary outcome measures
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.
+13 moreSenicapoc Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 10 mg daily SenicapocExperimental Treatment1 Intervention
10 mg daily Senicapoc for 52 weeks
Group II: Placebo GroupPlacebo Group1 Intervention
Placebo daily for 52 weeks
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,464 Total Patients Enrolled
John Olichney, MDPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a shunt or catheter implanted in your brain for draining fluid.I take daily medication to prevent blood clots.I have someone who sees me at least 6 hours a week and can provide information about me.Your test score on the Montreal Cognitive Assessment (MoCA) at the Screening visit needs to be between 15 and 28 after considering your level of education.You have struggled with alcohol or drug problems in the last 5 years.I have been on blood thinner medication within 2 weeks of a spinal tap.Your platelet count is lower than it should be.You don't have good veins for taking blood samples.Your blood clotting tests (INR/PT and aPTT) done within 14 days should be normal, with no signs of increased clotting risk.You don't have easy access to your veins for taking multiple blood samples.I regularly use medications for my brain or mood.People with probable Alzheimer's disease and a specific measurement of brain activity below a certain level.I am willing to possibly receive a placebo instead of the active drug.You are allergic to similar chemicals, like clotrimazole.I have had a serious brain infection or head injury that affects my thinking.I am fluent in English or Spanish.You have been diagnosed with mild or very mild dementia.You need to have at least 20/50 vision with or without glasses for seeing things far away.You have a history of ongoing mental health issues, recent major depression, or have had thoughts of harming yourself.I do not have severe heart issues, breathing problems, unstable blood conditions, or a life expectancy under 3 years.I am between 55 and 85 years old.I do not have unstable liver, kidney issues, or severely reduced kidney function.I have a history of bleeding disorders.I am not using any experimental Alzheimer's treatments.I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.I cannot swallow pills.I agree to use effective birth control until 78 weeks after the study ends.I have been diagnosed with early memory loss or mild Alzheimer's disease.I have been exposed to more than 2 rem of radiation in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: 10 mg daily Senicapoc
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I become a part of this research?
"This clinical trial is only for patients with Alzheimer's disease that are between the ages of 55 and 85. So far, around 55 people have been enrolled in the study."
Answered by AI
Are we still able to sign people up for this experiment?
"The trial is still open and recruiting patients, according to the listing on clinicaltrials.gov. This information was first posted on March 18th, 2022 and edited most recently on March 23rd of the same year."
Answered by AI
Does the research on Senicapoc date back far?
"Currently, there are two clinical trials underway for senicapoc. None of those trials are in phase 3. Most of the studies for this treatment are based in Boston, Massachusetts; however, there are three locations running these trials."
Answered by AI
Will this experiment be testing on elderly individuals?
"The target age range for participants in this clinical trial is those who are over 55 and under 85 years old."
Answered by AI
What are some of the more severe side effects associated with Senicapoc?
"While Phase 2 trials are not as reliable as Phase 3 trials, our team believes that Senicapoc is safe enough to warrant a score of 2."
Answered by AI
How many individuals are included in the research project?
"That is correct. The information available on clinicaltrials.gov indicates that this trial is actively searching for participants. This trial was first posted on 3/18/2022 and was last updated on 3/23/2022. Currently, the study is looking for 55 participants at 2 locations."
Answered by AI
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