Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm (WHIMS-Y)
WHIMS-Y will provide the WHI information on one of the most enduring negative consequences of postmenopausal HT; a relative deficit in cognitive function and an increased risk for clinically significant cognitive impairment that remain in the cohort after the cessation of study-prescribed HT.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Women's Health Initiative Memory Study of Younger Women|
- All-cause dementia [ Time Frame: Measured once a year ] [ Designated as safety issue: No ]One time per year, participants will have a cognitive assessment administered over the telephone.
- Mild Cognitive Impairment [ Time Frame: 1 time per year ] [ Designated as safety issue: No ]Once per year, participants will receive a cognitive assessment by telephone.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Previous HT use and cognition
Women who were aged 50-54 at the time of randomization into the WHI hormone trials.
The Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) is proposed to assess the long-term impact of random assignment to postmenopausal hormone therapy (Medroxyprogesterone, Estrogens, Conjugated or Estrogen-only or placebo) among women who were aged 50-54 at the time of randomization into the WHI hormone trials. Secondary objectives relate to the consistency of any treatment effects across unopposed or opposed therapy and whether there exists evidence of graded relationships between cognitive effects and age of administration, years from menopause, and baseline risk factors for cognitive impairment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124773
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Stephen R Rapp, PhD||Wake Forest School of Medicine|