Clinical trial NCT02122198: Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
Official title: Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Executive Dysfunction
Endothelial Dysfunction
Cardiovascular Disease
Keywords: Cognitive impairment
Executive function
Arterial stiffness
Endothelial function
Menopause
Women's health
Hormone therapy
functional MRI
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 17
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Prefrontal Cortex Brain Activation at 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Prefrontal Cortex Brain Activation at 9 Months
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Changes in Endothelial Function at 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Endothelial Function at 9 Months
timeFrame: Baseline, 9 months
measure: Changes in Artery Compliance at 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Artery Compliance at 9 Months
timeFrame: Baseline, 9 months
measure: Changes in Executive Cognitive Function: Trails A, 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Executive Cognitive Function: Trails A, 9 Months
timeFrame: Baseline, 9 months
measure: Changes in Executive Cognitive Function: RAVLT, 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Executive Cognitive Function: RAVLT, 9 Months
timeFrame: Baseline, 9 months
measure: Changes in Executive Cognitive Function: Trails B, 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Executive Cognitive Function: Trails B, 9 Months
timeFrame: Baseline, 9 months
measure: Changes in Executive Cognitive Function: Stroop, 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Executive Cognitive Function: Stroop, 9 Months
timeFrame: Baseline, 9 months
measure: Changes in Executive Cognitive Function: Digits Span Forward and Backward, 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Executive Cognitive Function: Digits, 9 Months
timeFrame: Baseline, 9 months
measure: Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 6 Months
timeFrame: Baseline, 6 months
measure: Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 9 Months
timeFrame: Baseline, 9 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Boulder
country: United States
facility: University of Colorado Boulder Intermountain Neuroimaging Consortium
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kerry L Hildreth, MD
role: PRINCIPAL_INVESTIGATOR
References: