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

Summary

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. The investigators 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.

Conditions

• Cognitive Impairment
• Executive Dysfunction
• Endothelial Dysfunction
• Cardiovascular Disease

Interventions

DRUG

Leuprolide acetate

Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.

DRUG

Estradiol

Climara transdermal patch 0.075mg/day applied weekly months 6-9

DRUG

Medroxyprogesterone

Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.

DRUG

Placebo

placebo

Sponsors & Collaborators

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Kerry L Hildreth, MD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-09-08

Primary Completion

2017-05-30

Completion

2017-09-15

Countries

• United States

Study Locations