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Search / Trial NCT04129060

Cholinergic Health After Menopause (CHAMP)

Launched by UNIVERSITY OF VERMONT · Oct 14, 2019

Trial Information

Current as of June 01, 2025

Completed

Keywords

ClinConnect Summary

The CHAMP study is exploring how menopause affects brain function and the risk of Alzheimer's disease in women. Researchers want to understand why some women experience cognitive changes during menopause while others do not. They believe that changes in hormones during menopause may impact a brain system related to memory and learning, known as the cholinergic system. By studying these changes, the researchers aim to identify factors that could help predict which women might be at a higher risk for cognitive decline as they age.

To participate in this study, women aged 50 to 70 who are postmenopausal and in good health may be eligible. Participants should not be smokers or currently using certain medications, such as hormone therapy or antidepressants, and must have normal brain function as determined by specific tests. During the study, participants will undergo tests to measure their memory and brain activity, and their results will help researchers understand the connection between menopause and cognitive health. This research is significant because it could lead to personalized strategies to support brain health in women after menopause.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Women aged 50-70 years
  • Postmenopausal
  • Nonsmokers
  • Not taking hormone therapy, selective serotonin uptake inhibitors (SSRIs(, phytoestrogens, selective estrogen receptor modulators (SERMS), or antiestrogen medications and will be at least one year without such treatment
  • Physically healthy
  • No cardiovascular disease other than mild hypertension. Subjects will also not have current untreated or unremitted Axis I or II psychiatric or cognitive disorders (see screening below).
  • Intelligence quotient (IQ) in the normal range \>80
  • Normal neuropsychological test performance
  • Exclusion Criteria:
  • Mild Cognitive Impairment (MCI) or dementia - Montreal Cognitive Assessment \<26, Mattis Dementia Rating Scale \<130, and Global Deterioration Scale \>2
  • History of cancer treatment with cytotoxic and/or ongoing (current) maintenance targeted chemotherapy
  • Blood pressure \> 160/100 (untreated)
  • Untreated thyroid disease
  • Significant cardiovascular disease
  • Asthma or chronic obstructive pulmonary disease (COPD)
  • Active peptic ulcer
  • Hyperthyroidism
  • Epilepsy
  • Current untreated or unremitted Axis I psychiatric disorders
  • Use of medications that are on our prohibited medications list

About University Of Vermont

The University of Vermont (UVM) is a leading academic institution known for its commitment to advancing healthcare through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, UVM leverages its diverse expertise in medicine, public health, and biomedical sciences to conduct cutting-edge clinical studies. The university aims to translate scientific findings into effective treatments and interventions, ultimately improving patient outcomes and contributing to the broader medical community. UVM's research facilities and access to a wide patient population support its mission to foster a culture of inquiry and excellence in clinical research.

Locations

Burlington, Vermont, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Julie A Dumas, Ph.D.

Principal Investigator

University of Vermont

Paul A Newhouse, M.D.

Principal Investigator

Vanderbilt University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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