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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
Must not have
Asthma or chronic obstructive pulmonary disease (COPD)
Hyperthyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two hours post drug administration
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have asthma or COPD.
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I have an overactive thyroid.
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I have a serious heart condition.
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I have an active stomach ulcer.
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I am not taking any medications that are not allowed in this study.
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I have epilepsy.
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I have been treated with chemotherapy for cancer.
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I have a thyroid condition that hasn't been treated.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
277 Previous Clinical Trials
3,743,994 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
901 Previous Clinical Trials
938,562 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
~0 spots leftby Nov 2024
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