Hormones and Cognition in the Menopausal Transition
The purpose of this study is to determine if the menopausal transition is associated with subjective and objective cognitive declines that ameliorate in menopause. 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. 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.
Age-associated Memory Impairment
Alteration of Cognitive Function
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Hormones and Cognition in the Menopausal Transition|
Subjects will have 20 mL of blood drawn by venipuncture by a trained nurse
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
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 2 skipped periods over the past 12 months (cycle double usual length) and one period of amenorrhea (over 60 days without a period), with at least one menstrual cycle over the past 12 months.
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. Measures of interest will be the percentage of women in each group with absolute and relative cognitive deficits, change over time in performance on neuropsychological tests and scores on depression and anxiety scales, and correlations between cognitive function, mood and hormone level.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429103
|United States, New York|
|University of Rochester Clinical Research Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Miriam Weber, PhD||Department of Neurology, University of Rochester|