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

Status:	Completed
Conditions:	Cognitive Studies, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases, Psychiatry / Psychology
Healthy:	No
Age Range:	40 - 60
Updated:	7/25/2018
Start Date:	September 8, 2014
End Date:	September 15, 2017

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.

Inclusion Criteria:

1. Volunteers will be healthy women aged 40 to 60 years

2. Are enrolled in the parent FAME study (NCT01712230).

The Investigators 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

We found this trial at

sites

University of Colorado Anschutz Medical Campus

13001 E 17th Pl
Aurora, Colorado 80045

(303) 724-5000