Status:
RECRUITING
Choline Dose Ranging in Postmenopausal Women
Lead Sponsor:
Julie Dumas
Conditions:
Menopause
Eligibility:
FEMALE
50-65 years
Phase:
NA
Brief Summary
This study will use a randomized placebo-controlled trial to examine smaller doses of choline and whether a signal in the brain is detectable using fMRI. This study will examine if an even smaller dos...
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. Clinical and preclinical studies...
Eligibility Criteria
Inclusion
- Women aged 50-65 years
- Postmenopausal: Women who are postmenopausal will have not had a period in the last 12 months, have FSH\>30 IU/L, and estradiol (E2) \<50 pg/ml.
- Nonsmokers
- Not taking hormone therapy, SSRIs, phytoestrogens, 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).
- IQ in the normal range \>80
- Normal neuropsychological test performance
Exclusion
- 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 COPD
- Active peptic ulcer
- Hyperthyroidism
- Epilepsy
- Current untreated or unremitted Axis I psychiatric disorders Use of medications on the Prohibited medications (see list)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06924541
Start Date
September 1 2024
End Date
March 1 2026
Last Update
September 11 2025
Active Locations (1)
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1
University of Vermont
Burlington, Vermont, United States, 05405