Cholinergic Health After Menopause (CHAMP)

Phase 1

Recruiting

• Conditions: Postmenopausal Symptoms; Aging; Alzheimer Disease

• Registration Number: NCT04129060
• Lead Sponsor: University of Vermont

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Oxygen Dependent (BOLD) functional magnetic resonance imaging (fMRI);Working Memory Performance;Basal Forebrain Cholinergic System Volume