Status:
COMPLETED
Cholinergic Health After Menopause (CHAMP)
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
Vanderbilt University Medical Center
Conditions:
Postmenopausal Symptoms
Aging
Eligibility:
FEMALE
50-70 years
Phase:
EARLY_PHASE1
Brief 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 cognitio...
Detailed Description
The brain is a major target for circulating gonadal steroids and the change in hormone levels after menopause is likely to have implications for cognitive functioning. A number of clinical and preclin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04129060
Start Date
March 15 2020
End Date
December 16 2024
Last Update
December 16 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
2
University of Vermont
Burlington, Vermont, United States, 05401