This study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.

Condition
Aging Menopause

Further Study Details: 

Expected Total Enrollment:  71

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.

Subjects will undergo PET and MRI scans and neuropsychological assessments initially and at the end of the two-year follow-up period. These procedures will allow us to evaluate brain metabolism and cognitive performance at baseline and two years following continuation or discontinuation of estrogen therapy.

We hypothesize that women who discontinue estrogen will show more evidence of decline than those who continue estrogen. This project will expand current knowledge of effects of estrogen by 1) determining whether estrogen use among postmenopausal women at risk for cognitive decline is protective of brain metabolism, 2) identifying early predictors for cognitive decline, and 3) developing guidelines for estrogen use in postmenopausal women.

Ages Eligible for Study:  50 Years   -   65 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Women between the ages of 50 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 Criteria:

• 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.)

Toni Wroolie, PhD      650-724-9269    twroolie@stanford.edu
Heather Kenna      650-724-0521    hkenna@stanford.edu

California
      Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences, Stanford,  California,  94070-5723,  United States; Recruiting

Study chairs or principal investigators

Natalie Rasgon, MD, PhD,  Principal Investigator,  Stanford University School of Medicine, Dept of Psychiatry and Behavioral Sciences   
John Brooks, MD, PhD,  Principal Investigator,  University of California, Los Angeles   
Terence Ketter, MD,  Principal Investigator,  Stanford University   
Jerome Yesavage, MD,  Principal Investigator,  Stanford University   

Study ID Numbers:  IA0063; SPO #29004; Grant #R01 AG022008
Record last reviewed:  November 2004
Last Updated:  November 19, 2004
Record first received:  November 17, 2004
ClinicalTrials.gov Identifier:  NCT00097058
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08