N/A
N=17
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
Cognitive Impairment · Executive Dysfunction · Endothelial Dysfunction · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02122198 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Changes in Prefrontal Cortex Brain Activation at 6 Months — 90.64; -62.20; 28.07; -79.04 beta-weight
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Leuprolide acetate (Drug); Estradiol (Drug); Medroxyprogesterone (Drug); Placebo (Drug)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Prefrontal Cortex Brain Activation at 6 Months |
90.64; -62.20; 28.07; -79.04; 92.45; -53.05 | — |
| PRIMARY Changes in Prefrontal Cortex Brain Activation at 9 Months |
-27.15; -88.87; -77.23 | — |
| SECONDARY Changes in Endothelial Function at 6 Months |
— | — |
| SECONDARY Changes in Endothelial Function at 9 Months |
— | — |
| SECONDARY Changes in Artery Compliance at 6 Months |
-0.048; -0.095 | — |
| SECONDARY Changes in Artery Compliance at 9 Months |
-0.002 | — |
| SECONDARY Changes in Executive Cognitive Function: Trails A, 6 Months |
2.79; -5.82 | — |
| SECONDARY Changes in Executive Cognitive Function: Trails A, 9 Months |
-5.46 | — |
| SECONDARY Changes in Executive Cognitive Function: RAVLT, 6 Months |
-1.00; -1.38 | — |
| SECONDARY Changes in Executive Cognitive Function: RAVLT, 9 Months |
— | — |
| SECONDARY Changes in Executive Cognitive Function: Trails B, 6 Months |
14.23; -4.32 | — |
| SECONDARY Changes in Executive Cognitive Function: Trails B, 9 Months |
14.14 | — |
| SECONDARY Changes in Executive Cognitive Function: Stroop, 6 Months |
-0.67; 0.25 | — |
| SECONDARY Changes in Executive Cognitive Function: Stroop, 9 Months |
7.33 | — |
| SECONDARY Changes in Executive Cognitive Function: Digits Span Forward and Backward, 6 Months |
1.00; -0.88; -0.67; 0.00 | — |
| SECONDARY Changes in Executive Cognitive Function: Digits, 9 Months |
1.00; 1.0 | — |
| SECONDARY Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 6 Months |
-5.33; 0.25 | — |
| SECONDARY Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 9 Months |
7.33 | — |
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
- Volunteers will be healthy women aged 40 to 60 years
- 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
- mini-mental state examination (MMSE) score 27 or less
- history of neurologic disease or major psychiatric illness
- major depressive episode within the past 12 months
- history of learning disability
- less than high-school education
- current smoking
- use of psychoactive medications in the past 3 months (stable use of anti- depressant medication is allowed)
- contraindications to MRI scanning
Data sourced from ClinicalTrials.gov (NCT02122198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.