Hormones and Cognition in the Menopausal Transition
Hormones and Cognition in the Menopausal Transition
Overall Status:
No longer recruiting
Brief Description:
The purpose of this study is to determine if the menopausal transition is associated with cognitive decline that improves in menopause. The investigators predict that as women transition from early perimenopause to late perimenopause, their performance on attentionally mediated and verbal memory tasks will decline, and that as they transition from late perimenopause to menopause, their performance will improve.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
40 Years | 60 Years | Female | Yes |
Inclusion Criteria:
- Early perimenopause is defined as the presence of irregular periods (cycle length differs by 7 days from usual)
- Late perimenopause is defined as at least two skipped periods over the past 12 months (cycle double the usual length); one missed period (over 60 days without a period); and at least one menstrual cycle over the past 12 months.
Exclusion Criteria:
- History of neurological disease known to affect cognitive function (for example, stroke, multiple sclerosis)
- History of major psychiatric illness
- Currently pregnant or breastfeeding
- Surgical menopause or use of exogenous hormone preparations affecting ovarian or pituitary function in the past 3 months
- Hysterectomy or oopherectomy
- Women who choose to initiate hormone therapy at some point during the study will continue to be followed, but their data obtained after such therapy is initiated will be analyzed separately
Detailed Description:
The investigators hypothesize that perimenopause is associated with both subjective memory complaints and objective declines in attentionally mediated cognitive tasks. The investigators also hypothesize that this is time-limited: As women transition from early perimenopause to late perimenopause, their performance on attentionally mediated and verbal memory tasks will decline, and as they transition from late perimenopause to menopause, their performance will improve.
Two groups of women will be recruited, those in early perimenopause and those in mid to late perimenopause. Tests of attention, working memory, mental flexibility, processing speed, and retentive memory will be administered to each subject at 6-month intervals for 5 years. Additionally, women will be asked to fill out questionnaires about their mood, memory functioning, health, and quality of life. The investigators will also calculate each subject's Body Mass Index (BMI) and waist circumference at each visit. Finally, serum levels of reproductive hormones will be taken. Outcomes include correlations between cognitive function, mood, and hormone levels.
Locations:
| Map Marker | City | State | Zip Code | |
|---|---|---|---|---|
Geolocation is 43.1224766, -77.6242574 | University of Rochester Clinical Research Center | Rochester | New York | 14642 |
Lead Sponsor:
| Agency |
|---|
University of Rochester |
Collaborator Sponsor:
| Agency |
|---|
National Institutes of Health (NIH) |
National Institute on Aging (NIA) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Miriam Weber, PhD | Principal Investigator | Department of Neurology, University of Rochester |
Study Contact:
| Name | Phone | |
|---|---|---|
Kelly Bellenger | 585-273-2046 |
Locations
ClinicalTrials.gov ID
NCT01429103 (follow link to view full record on ct.gov in new window)
Official Title:
Hormones and Cognition in the Menopausal Transition
Study Start Date:
May 2011
Study End Date:
November 2016
Enrollment:
90
