Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-04-11 @ 12:04 AM
Study NCT ID:
NCT00745056
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2008-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining the Relationship Between Hormone Therapy (HT) and Cognitive Function (The WHIMS-ECHO Study)
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WHIMS-ECHO
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: