Overview

This trial has been completed.

Condition dementia
Sponsor Wake Forest University Health Sciences
Start date June 2009
End date June 2016
Trial size 1362 participants
Trial identifier NCT01124773, 699

Summary

WHIMS-Y provides valuable information on the long-term effects on risk of cognitive impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials. Following cessation of study-prescribed HT cognitive function and impairment were assessed.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Women who were aged 50-54 at the time of randomization into the WHI hormone trials.

Primary Outcomes

Measure
All-cause dementia and Mild Cognitive Impairment
time frame: Measured once a year

Secondary Outcomes

Measure
Global and domain specific cognitive function.
time frame: Measured once a year

Eligibility Criteria

Female participants from 50 years up to 54 years old.

Inclusion Criteria: - Must be enrolled in the Women's Health Initiative Extension Exclusion Criteria: - Not enrolled in the Women's Health Initiative Extension

Additional Information

Official title Women's Health Initiative Memory Study of Younger Women
Principal investigator Stephen R Rapp, PhD
Description 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 (equine estrogen alone or in combination with medroxyprogesterone versus 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Wake Forest University Health Sciences.