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CompletedNCT00097058Updated Nov 19, 2014

Estrogen Use in Protection From Cognitive Decline

An observational study in Aging and Menopause, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-19.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
71
Ages
45 Years to 65 Years
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Aging
  • Menopause

Keywords

  • Aging
  • Menopause
  • Estrogen Replacement Therapy
  • Cognitive Decline
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 71 is below the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
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

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.)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
71 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Continue current hormone therapy

  • 2

    Taper off hormone therapy

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What researchers measure

Primary outcomes

  1. Changes in cognition and brain metabolism

    Time frame: Baseline and 24 months

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Study locations

1 site
  • Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences
    Stanford, California 94070-5723, United States
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References and documents

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. doi: 10.1016/s0925-4927(01)00084-1. PubMed 11472860 ↗
  • 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. doi: 10.1016/s0925-4927(00)00085-8. PubMed 11231099 ↗
  • 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. doi: 10.1016/j.psyneuen.2004.09.002. PubMed 15511602 ↗
  • Rasgon NL, Geist CL, Kenna HA, Wroolie TE, Williams KE, Silverman DH. Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia. PLoS One. 2014 Mar 12;9(3):e89095. doi: 10.1371/journal.pone.0089095. eCollection 2014. PubMed 24622517 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00097058
Lead sponsor
Stanford University
Collaborators
National Institute on Aging (NIA)
Responsible party
Natalie Rasgon (Principal Investigator, Stanford University) — Principal investigator
First posted
Nov 18, 2004
Start date
Aug 2003
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Nov 19, 2014

Study contacts

Natalie Rasgon, MD, PhD
principal investigator · Stanford University School of Medicine, Dept of Psychiatry and Behavioral Sciences
Terence Ketter, MD
principal investigator · Stanford University
Jerome Yesavage, MD
principal investigator · Stanford University
Jennifer Hoblyn, MD
principal investigator · VA Palo Alto Health Care System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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