Estrogen Use in Protection From Cognitive Decline

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by National Institute on Aging (NIA). Recruitment status was Active, not recruiting

First Received on November 17, 2004. Last Updated on August 27, 2009 History of Changes

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00097058

Purpose

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

Condition
Aging Menopause

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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

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

Biospecimen Retention: Samples With DNA

whole blood serum urine

Estimated Enrollment:	71
Study Start Date:	August 2003
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Continue current hormone therapy
2 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.

Eligibility

Ages Eligible for Study:	45 Years to 65 Years
Genders 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.

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097058

Locations

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

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

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:

Rasgon NL, Small GW, Siddarth P, Miller K, Ercoli LM, Bookheimer SY, Lavretsky H, Huang SC, Barrio JR, Phelps ME. Estrogen use and brain metabolic change in older adults. A preliminary report. Psychiatry Res. 2001 Jul 1;107(1):11-8.

Rasgon NL, Thomas MA, Guze BH, Fairbanks LA, Yue K, Curran JG, Rapkin AJ. Menstrual cycle-related brain metabolite changes using 1H magnetic resonance spectroscopy in premenopausal women: a pilot study. Psychiatry Res. 2001 Feb 28;106(1):47-57.

Dunkin J, Rasgon N, Wagner-Steh K, David S, Altshuler L, Rapkin A. Reproductive events modify the effects of estrogen replacement therapy on cognition in healthy postmenopausal women. Psychoneuroendocrinology. 2005 Apr;30(3):284-96.

Responsible Party:	Natalie Rasgon, MD, PhD, Stanford University
ClinicalTrials.gov Identifier:	NCT00097058 History of Changes
Obsolete Identifiers:	NCT00238589
Other Study ID Numbers:	IA0063, SPO #29004, Grant #R01 AG022008
Study First Received:	November 17, 2004
Last Updated:	August 27, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Aging
Menopause
Estrogen Replacement Therapy
Cognitive Decline

Additional relevant MeSH terms:

Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Estrogens

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012