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Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cognitive Impairment; Executive Dysfunction; Endothelial Dysfunction; Cardiovascular Disease

Intervention: Leuprolide acetate (Drug); Estradiol (Drug); Medroxyprogesterone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Colorado, Denver

Official(s) and/or principal investigator(s):
Kerry L Hildreth, MD, Principal Investigator, Affiliation: University of Colorado, Denver

Overall contact:
Kerry L Hildreth, MD, Phone: 303-724-1927, Email: kerry.hildreth@ucdenver.edu


Complaints about memory and thinking are common in women as they go through menopause and estrogen levels fall. The ovarian hormone estrogen is important for supporting normal cognitive function, and changes in brain activity and function occur when estrogen levels are decreased. Estrogen is also important for maintaining healthy blood vessels which also support normal cognitive function. In Alzheimer's disease and other types of dementia, there is significant damage to the blood vessels in the brain. This study will test whether changes in brain activity and function with the loss of estrogen are related to changes in vascular function. We will measure vascular function using ultrasound, and brain activity using MRI scans in women who are enrolled in the Females, Aging, Metabolism and Exercise (FAME) study (NCT01712230). In the FAME study, healthy premenopausal women either take a medication to decrease their estrogen levels, or a placebo. This sub-study may provide new information about how estrogen affects vascular function and cognitive function, and lead to new ways to prevent or delay cognitive impairment or dementia.

Clinical Details

Official title: Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Prefrontal cortex brain activation

Secondary outcome:

Endothelial function

Carotid artery compliance

Executive cognitive function


Minimum age: 40 Years. Maximum age: 60 Years. Gender(s): Female.


Inclusion Criteria: Volunteers will be healthy women aged 40 to 60 years who are enrolled in the parent FAME study (NCT01712230). We will consent up to 80 subjects with the aim of enrolling 17 in each of the 2 groups (placebo, GnRH agonist). Exclusion Criteria: 1. mini-mental state examination (MMSE) score 27 or less 2. history of neurologic disease or major psychiatric illness 3. major depressive episode within the past 12 months 4. history of learning disability 5. less than high-school education 6. current smoking 7. use of psychoactive medications in the past 3 months (stable use of anti- depressant medication is allowed) 8. contraindications to MRI scanning

Locations and Contacts

Kerry L Hildreth, MD, Phone: 303-724-1927, Email: kerry.hildreth@ucdenver.edu

University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045, United States; Recruiting
Kerry L Hildreth, MD, Phone: 303-724-1927, Email: kerry.hildreth@ucdenver.edu
Kerrie L Moreau, PhD, Sub-Investigator
Jim Grigsby, PhD, Sub-Investigator
Robert S Schwartz, MD, Sub-Investigator
Wendy M Kohrt, PhD, Sub-Investigator
Kerry L Hildreth, MD, Principal Investigator

University of Colorado Boulder Intermountain Neuroimaging Consortium, Boulder, Colorado 80309, United States; Recruiting
Marie T Banich, PhD, Phone: 303-492-6655, Email: marie.banich@colorado.edu
Marie T Banich, PhD, Sub-Investigator

Additional Information

Starting date: June 2014
Last updated: June 8, 2015

Page last updated: August 23, 2015

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