Overview

This trial is active, not recruiting.

Condition dementia
Sponsor Wake Forest University Health Sciences
Start date August 2008
End date November 2021
Trial size 2922 participants
Trial identifier NCT00745056, 1436

Summary

This is a prospective, observational study of the cohort of older post-menopausal participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials. Annual cognitive assessments and ascertainment of cognitive impairment enable the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive vulnerability and resilience in older women.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
All-cause dementia and Mild Cognitive Impairment
time frame: Measured annually

Secondary Outcomes

Measure
Global and domain specific cognitive function
time frame: Measured annually

Eligibility Criteria

Female participants at least 65 years old.

Inclusion Criteria: - Participated in the WHIMS study Exclusion Criteria - Non-English speaking - Hearing Impaired

Additional Information

Official title Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes
Principal investigator Stephen R. Rapp, PhD
Description Identification of the predictors of cognitive impairment and cognitive resilience among aging women is important because the incidence of mild cognitive impairment (MCI) and dementia increases with age and women live the longest. The Women's Health Initiative Memory Study examined the impact of randomization to hormone therapy (conjugated equine estrogen alone or in combination with medroxyprogesterone vs. placebo) in a subset of participants aged 65-79 years at enrollment into WHI and the WHI Hormone Trials. WHIMS revealed an increased risk of all-cause dementia and MCI plus poorer global cognitive function among women randomized to HT compared to those receiving placebo. WHIMS ECHO is a prospective, observational study of the remaining cohort of WHIMS participants following cessation of treatment. Annual cognitive assessments of learning, attention, memory, working memory, executive function and language are conducted by telephone by trained staff and adjudication of incident cognitive impairment (MCI and dementia) continues. This enables the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive aging and resilience in older women.
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.