Trial record 1 of 1 for:    Estrogen Use in Protection from Cognitive Decline
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Estrogen Use in Protection From Cognitive Decline

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University
ClinicalTrials.gov Identifier:
NCT00097058
First received: November 17, 2004
Last updated: May 14, 2014
Last verified: June 2012

November 17, 2004
May 14, 2014
August 2003
December 2014   (final data collection date for primary outcome measure)
Changes in cognition and brain metabolism [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00097058 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Estrogen Use in Protection From Cognitive Decline
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood serum urine

Non-Probability Sample

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.

  • Aging
  • Menopause
Not Provided
  • 1
    Continue current hormone therapy
  • 2
    Taper off hormone therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
71
December 2014
December 2014   (final data collection date for primary outcome measure)

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.)
Female
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00097058
IA0063, R01AG022008, SPO #29004, Grant #R01 AG022008
Yes
Natalie Rasgon, Stanford University
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
Stanford University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP