Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04129060 · ClinicalTrials.gov registry record · Early Phase 1
Cholinergic Health After Menopause (CHAMP)
A Early Phase 1 study, sponsored by University of Vermont.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 98
- Enrollment target
NCT04129060 is a Early Phase 1 study that has completed, run by University of Vermont. The registered enrollment target is 98 participants.
The verdict
NCT04129060, a Early Phase 1 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
Women are at increased risk for Alzheimer's disease (AD). Notably at menopause, some women experience a change in cognition. However, not all women experience negative effects of menopause on cognition. The cognitive changes that occur at menopause have not yet been connected to late life risk for pathological aging including AD. Thus, understanding the neurobiological factors related to individual differences in cognition at menopause is critical for understanding normal cognitive aging and for determining risk for pathological aging. The challenge in understanding the role of estrogen loss on the risk for AD is the long lag time between the hormonal changes at menopause and the clinical manifestations of AD. Thus, identifying how the hormone changes after menopause are related to AD risk will alter the risk calculus for postmenopausal women in the future. The novel study proposed here will examine an established AD-related neurotransmitter-based mechanism that may also underlie cognitive changes after menopause. The investigators propose that the change in the hormonal milieu at menopause interacts with the cholinergic system and other brain pathologies to influence a woman's risk for cognitive decline. Preclinical studies have shown that estrogen is necessary for normal cholinergic functioning and its withdrawal leads to cholinergic dysfunction and cognitive impairment. It is important to determine whether menopause-related cognitive changes correlate with both cholinergic functional integrity and established AD biomarkers that portend increased risk for late-life cognitive impairment or dementia. This study will examine brain functioning following cholinergic blockade to separate individuals into those who are able to compensate for the hormone change after menopause and those who are not. The investigators hypothesize women with poor compensation have increased sensitivity to cholinergic blockade by showing poor performance on a cognitive task, altered brain a
Interventions
- DRUG Cholinergic antagonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2020-03-15 |
| Est. Completion | 2024-12-16 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04129060
The ClinicalTrials.gov registry entry for NCT04129060 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cholinergic antagonist is the first listed.
NCT04129060 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04129060 about?
NCT04129060 is a clinical study titled "Cholinergic Health After Menopause (CHAMP)". Women are at increased risk for Alzheimer's disease (AD). Notably at menopause, some women experience a change in cognition. However, not all women experience negative effects of menopause on cognition. The cognitive changes that occur at menopause have not yet been connected to late life risk for p...
What is the current status of trial NCT04129060?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 98 participants. The study started on 2020-03-15. Estimated completion is 2024-12-16.
What interventions are being tested in trial NCT04129060?
The interventions under investigation include: Cholinergic antagonist (DRUG).
Who is sponsoring clinical trial NCT04129060?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.