Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
71 participants
OBSERVATIONAL
2003-08-31
2014-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Continue current hormone therapy
No interventions assigned to this group
2
Taper off hormone therapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
45 Years
65 Years
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Stanford University
OTHER
Responsible Party
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Natalie Rasgon
Principal Investigator
Principal Investigators
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Natalie Rasgon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University School of Medicine, Dept of Psychiatry and Behavioral Sciences
Terence Ketter, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Jerome Yesavage, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Jennifer Hoblyn, MD
Role: PRINCIPAL_INVESTIGATOR
VA Palo Alto Health Care System
Locations
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Stanford University School of Medicine, Dept. of Psychiatry and Behavioral Sciences
Stanford, California, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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SPO #29004
Identifier Type: -
Identifier Source: secondary_id
Grant #R01 AG022008
Identifier Type: -
Identifier Source: secondary_id
IA0063
Identifier Type: -
Identifier Source: org_study_id
NCT00238589
Identifier Type: -
Identifier Source: nct_alias