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Estrogen Use in Protection From Cognitive Decline

This study has been completed.
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University Identifier:
First received: November 17, 2004
Last updated: November 17, 2014
Last verified: November 2014
This study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estrogen Use in Protection From Cognitive Decline

Further study details as provided by Natalie Rasgon, Stanford University:

Primary Outcome Measures:
  • Changes in cognition and brain metabolism [ Time Frame: Baseline and 24 months ]

Biospecimen Retention:   Samples With DNA
whole blood serum urine

Estimated Enrollment: 71
Study Start Date: August 2003
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Continue current hormone therapy
Taper off hormone therapy

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 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:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women between the ages of 45 and 65 years of age, currently on estrogen therapy for 1 year prior to enrollment in study, and at risk for cognitive decline.

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.)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00097058

United States, California
Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences
Stanford, California, United States, 94070-5723
Sponsors and Collaborators
Stanford University
National Institute on Aging (NIA)
Principal Investigator: Natalie Rasgon, MD, PhD Stanford University School of Medicine, Dept of Psychiatry and Behavioral Sciences
Principal Investigator: Terence Ketter, MD Stanford University
Principal Investigator: Jerome Yesavage, MD Stanford University
Principal Investigator: Jennifer Hoblyn, MD VA Palo Alto Health Care System
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Natalie Rasgon, Principal Investigator, Stanford University Identifier: NCT00097058     History of Changes
Obsolete Identifiers: NCT00238589
Other Study ID Numbers: IA0063
R01AG022008 ( US NIH Grant/Contract Award Number )
SPO #29004
Grant #R01 AG022008
Study First Received: November 17, 2004
Last Updated: November 17, 2014

Keywords provided by Natalie Rasgon, Stanford University:
Estrogen Replacement Therapy
Cognitive Decline

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017