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Clinical Trials/NCT00745056
NCT00745056
Completed
Not Applicable

Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes

Wake Forest University Health Sciences1 site in 1 country2,922 target enrollmentSeptember 11, 2008
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Wake Forest University Health Sciences
Enrollment
2922
Locations
1
Primary Endpoint
All-cause dementia and Mild Cognitive Impairment
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 11, 2008
End Date
November 4, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

All-cause dementia and Mild Cognitive Impairment

Time Frame: Measured annually

Secondary Outcomes

  • Global and domain specific cognitive function(Measured annually)

Study Sites (1)

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