Aging and Estrogen on Cortical Function
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Memory Loss, Cognitive Changes, Postmenopausal Symptoms
In brief
This study will focus on how estrogen affects parts of the brain associated with memory and how the effect of estrogen is altered with aging in postmenopausal women.
Key facts
- Study ID
- NCT01268046
- Run by
- Massachusetts General Hospital
- People needed
- 38
- Starts
- 2009-11-01
- Expected to finish
- 2013-12-02
- Last updated by the study team
- 2018-08-22
Who can join
Age: 45 and older, up to 80. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- young postmenopausal (age 45-55) or older (age 65-80) postmenopausal women
- otherwise healthy, non-obese women with normal blood pressure and a history of normal menopause, defined by the absence of menses for at least 12 months
- prescription hormone replacement treatment discontinued at least 3 months before study
- Normal or corrected normal vision
- Intelligence quotient (IQ) > 70 on the Wechsler Adult Reading Test (WTAR)*
- Absence of Mild Cognitive Impairment (MCI) and depression on the Mini Mental State Examination (MMSE)** and Beck Depression Inventory II (BDI-II).***
- Normal mammogram or breast MRI within the past 2 years
You may not qualify if…
- On gonadal hormone replacement medication, herbal supplements and/or over the counter menopause treatment within three months of study
- History of radiotherapy or chemotherapy.
- Absolute contraindications to the use of physiologic replacement doses of estrogen and/or history of coronary artery disease
- History of breast cancer, blood clot, pulmonary embolus, hypercoagulability and stroke.
- On centrally acting medications
- History of head trauma and/or neurologic disorder
- Contraindication to MRI (eg. metal implants) or PET imaging (eg. PET imaging studies in the previous 12 months)
- Concurrent participation in research studies involving medications and/or PET scans.
- Left handedness.
- Current breast lump(s) or family/genetic history of breast cancer in younger women (< 40 years old).
- Current smoking
Where it is running
- Reproductive Endocrine Unit, Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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