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Cholinergic Antagonist for Postmenopausal Cognitive Decline (CHAMP Trial)

Phase < 1
Recruiting
Led By Paul A Newhouse, M.D.
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women aged 50-70 years
Postmenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two hours post drug administration
Awards & highlights

CHAMP Trial Summary

This trial will study how changes in hormones after menopause may interact with the cholinergic system (which is involved in memory and other cognitive functions) to influence a woman's risk for cognitive decline.

Who is the study for?
The CHAMP study is for women aged 50-70 who are postmenopausal, non-smokers, and in good physical health without serious psychiatric or cognitive disorders. Participants should not have cardiovascular disease (except mild hypertension), be off certain hormone therapies and medications for a year, and must have normal IQ and neuropsychological test results.Check my eligibility
What is being tested?
This trial investigates how hormonal changes after menopause might affect the risk of Alzheimer's Disease by studying the brain's cholinergic system. It involves testing memory performance, brain activation, and brain structure following administration of a cholinergic antagonist to assess cognitive resilience.See study design
What are the potential side effects?
While specific side effects are not listed here, cholinergic antagonists can generally cause dry mouth, blurred vision, constipation, urinary retention, confusion especially in older adults; however individual experiences may vary.

CHAMP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 50 and 70.
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I have gone through menopause.
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I only have mild high blood pressure, no other heart conditions.
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I haven't taken hormone therapy or related medications for a year.
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I am in good physical health.

CHAMP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two hours post drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and two hours post drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Basal Forebrain Cholinergic System Volume
Blood Oxygen Dependent (BOLD) functional magnetic resonance imaging (fMRI)
Working Memory Performance

CHAMP Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo ChallengeExperimental Treatment1 Intervention
One of the two study days will be the oral placebo.
Group II: Mecamylamine ChallengeExperimental Treatment1 Intervention
One of the two study days will be the oral mecamylamine.

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
265 Previous Clinical Trials
3,743,371 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
853 Previous Clinical Trials
670,926 Total Patients Enrolled
Paul A Newhouse, M.D.Principal InvestigatorVanderbilt University
2 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

Cholinergic antagonist Clinical Trial Eligibility Overview. Trial Name: NCT04129060 — Phase < 1
Alzheimer's Disease Research Study Groups: Placebo Challenge, Mecamylamine Challenge
Alzheimer's Disease Clinical Trial 2023: Cholinergic antagonist Highlights & Side Effects. Trial Name: NCT04129060 — Phase < 1
Cholinergic antagonist 2023 Treatment Timeline for Medical Study. Trial Name: NCT04129060 — Phase < 1

Frequently Asked Questions

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

Are individuals still able to participate in this experiment?

"The clinical trial, posted on March 15th 2020 and recently updated on the 23rd of March 2022, is currently recruiting participants."

Answered by AI

Could I potentially become a subject in this research project?

"This medical research is in search of 120 elderly patients (aged 50-70) with Alzheimer's disease. In addition to this, women must meet further criteria like post menopause, non smoking status, abstinence from certain medications for 1 year or more and normal IQ score & neuropsychological test performance. Furthermore they should not have any untreated physical/mental health issues at the time of enrollment."

Answered by AI

To what extent has enrollment in this investigation grown?

"Yes, the information hosted on clinicaltrials.gov reflects that this medical experiment is still welcoming participants. It was initially announced on March 15th of 2020 and its most recent update came about on March 23rd 2022. Presently, 120 patients must be recruited from two separate sites."

Answered by AI

Is eligibility for this study limited to people under the age of 25?

"According to the prerequisites for enrolment, patients must be between 50 and 70 years old in order to participate."

Answered by AI
~0 spots leftby Mar 2024