Status:
COMPLETED
Estrogen Use in Protection From Cognitive Decline
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Aging
Menopause
Eligibility:
FEMALE
45-65 years
Brief Summary
This study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.
Detailed Description
A total of 71 postmenopausal women ages 50-65 on estrogen therapy will be randomized to continue or discontinue use of estrogen and will be followed for two years. Participants will undergo PET and M...
Eligibility Criteria
Inclusion
- Women between the ages of 45 and 65
- Currently on hormone replacement
- One year or more post complete cessation of menses
- Willing to sign the Human Subject Protection Consent form prior to enrollment in the study
- Willing to be randomized to continue or discontinue estrogen therapy
- Adequately visually and auditorially acute to allow neuropsychological testing
- Beyond 8 years of educational achievement to allow adequate neuropsychological testing
- Willing to undergo brain imaging
- At risk for cognitive decline, as defined by one or more of the following: Personal or family history of mood disorder, Hypothyroidism, Diabetes, Family history of Alzheimer's, APOE-4 allele
Exclusion
- Diagnosis of possible or probable Alzheimer's disease or dementia
- Cerebrovascular disease or uncontrolled hypertension (systolic BP \>170 or diastolic BP \>100)
- History of myocardial infarction within previous year or unstable heart disease
- History of significant liver disease, pulmonary disease, or current cancer
- Contraindication for MRI (metal in body, claustrophobia, etc.)
Key Trial Info
Start Date :
August 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00097058
Start Date
August 1 2003
End Date
November 1 2014
Last Update
November 19 2014
Active Locations (1)
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1
Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences
Stanford, California, United States, 94070-5723