NCT00097058

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2004

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

11.3 years

First QC Date

November 17, 2004

Last Update Submit

November 17, 2014

Conditions

AgingMenopause

Keywords

AgingMenopauseEstrogen Replacement TherapyCognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Changes in cognition and brain metabolism

    Baseline and 24 months

Study Arms (2)

1

Continue current hormone therapy

2

Taper off hormone therapy

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences

Stanford, California, 94070-5723, United States

Location

Related Publications (4)

  • 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.

    PMID: 11472860BACKGROUND

  • 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.

    PMID: 11231099BACKGROUND

  • 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.

    PMID: 15511602BACKGROUND

  • 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.

    PMID: 24622517DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood serum urine

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2004

First Posted

November 18, 2004

Study Start

August 1, 2003

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

US(1)