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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 below
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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a primary neurological disorder like stroke or epilepsy.
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I cannot take certain medications due to health risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after administration of second drug challenge, approximately 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and after administration of second drug challenge, approximately 72 hours for reporting.

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

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
908 Previous Clinical Trials
934,507 Total Patients Enrolled
Paul Newhouse, MDStudy DirectorVanderbilt University Medical Center
4 Previous Clinical Trials
669 Total Patients Enrolled

Media Library

Mecamylamine Challenge Clinical Trial Eligibility Overview. Trial Name: NCT04756232 — Phase < 1
Mild Cognitive Impairment Research Study Groups: Anticholinergic Challenge, Placebo Challenge
Mild Cognitive Impairment Clinical Trial 2023: Mecamylamine Challenge Highlights & Side Effects. Trial Name: NCT04756232 — Phase < 1
Mecamylamine Challenge 2023 Treatment Timeline for Medical Study. Trial Name: NCT04756232 — Phase < 1
~11 spots leftby May 2025