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N/A N=17 Randomized Triple-blind Basic Science

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

Cognitive Impairment · Executive Dysfunction · Endothelial Dysfunction · Cardiovascular Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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