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Cholinergic Blocker for Cognitive Impairment
Phase < 1
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
age ≥ 55
Be older than 18 years old
Must not have
primary neurological disorder (such as stroke, epilepsy, etc.)
medical contraindications to the drug challenge
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after administration of second drug challenge, approximately 72 hours
Summary
This trial will use a medicine that blocks a chemical called "acetylcholine" to study how it affects attention in people with Sickle Cell Disease. They think that people with SCD have to work harder to pay attention, and disrupting this process with the medicine will make it harder to pay attention.
Who is the study for?
This trial is for non-smoking adults aged 55 or older who have mild cognitive issues but are generally in good health. They should score above 25 on the MoCA test, indicating only slight memory concerns, and have a GDS rating below 3, showing minimal daily life impact.
What is being tested?
The study tests how an anticholinergic drug called Mecamylamine affects attention in aging individuals with slight cognitive decline. Participants will be compared to those taking a placebo while their brain activity and attention performance are monitored using EEG and specific tests.
What are the potential side effects?
Mecamylamine may cause side effects like dizziness, nausea, dry mouth, constipation, blurred vision or confusion. These symptoms result from its action on the nervous system but vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a primary neurological disorder like stroke or epilepsy.
Select...
I cannot take certain medications due to health risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after administration of second drug challenge, approximately 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after administration of second drug challenge, approximately 72 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants who complete EEG
Proportion of participants who complete study visits with drug challenge
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anticholinergic ChallengeExperimental Treatment1 Intervention
All participants will receive oral mecamylamine or IV scopolamine for 1 day
Group II: Placebo ChallengePlacebo Group1 Intervention
All participants will receive oral placebo for 1 day
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
901 Previous Clinical Trials
939,546 Total Patients Enrolled
Paul Newhouse, MDStudy DirectorVanderbilt University Medical Center
4 Previous Clinical Trials
669 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a primary neurological disorder like stroke or epilepsy.You do not smoke cigarettes or tobacco products.You have a good score on a test called Montreal Cognitive Assessment (MoCA), which measures your memory and thinking skills, and your Global Deterioration Scale (GDS) rating shows that you have mild or no cognitive impairment.I cannot take certain medications due to health risks.I am 55 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Anticholinergic Challenge
- Group 2: Placebo Challenge
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.
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