Estrogen Use in Protection From Cognitive Decline - Tabular View

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Estrogen Use in Protection From Cognitive Decline

This study is ongoing, but not recruiting participants.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Estrogen Use in Protection From Cognitive Decline

Official Title ^†

Estrogen Use in Protection From Cognitive Decline

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 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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Primary Outcome Measure ^†

Changes in cognition and brain metabolism [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Condition ^†

Aging
Menopause

Intervention ^†

MEDLINE PMIDs

11472860, 11231099, 15511602

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

August 2003

Completion Date

December 2010

Eligibility Criteria ^†

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.)

Gender

Female

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00097058

Organization ID

IA0063

Secondary IDs ^††

SPO #29004, Grant #R01 AG022008

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

Investigators ^†

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

Information Provided By

National Institute on Aging (NIA)

Verification Date

May 2008

First Received Date ^†

November 17, 2004

Last Updated Date

May 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.