Examining the Relationship Between Hormone Therapy (HT) and Cognitive Function (The WHIMS-ECHO Study)

Completed

• Conditions: Dementia

• Registration Number: NCT00745056
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study First Posted: 2008-09-01
• Study Start: 2008-09-11
• Status Verified: 2021-04
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2922

Inclusion Criteria

• Participated in the WHIMS study

Exclusion Criteria

• Non-English speaking
• Hearing Impaired

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause dementia and Mild Cognitive Impairment	Measured annually

Secondary Outcome Measures

Name	Time	Method
Global and domain specific cognitive function	Measured annually

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States