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Completed

NCT Number: NCT00097058

Estrogen Use in Protection From Cognitive Decline

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

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences

Stanford, California, 94070-5723, United States

About this study

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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.)

Treatment and study plan

Primary outcomes

  1. Changes in cognition and brain metabolism

    Time frame: Baseline and 24 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2004
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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