Women's Health Initiative Memory Study
The WHIMS study aimed to determine the incidence of all-cause dementia, diagnosed through the screening of cognitive functioning and neurologic and neuropsychological evaluations in women participating in the hormone replacement therapy (HRT) trial of the Women's Health Initiative (WHI).
Specifically WHIMS aimed to:
- Quantify the efficacy of HRT in reducing the incidence of clinically diagnosed all-cause dementia separately in women who have had a hysterectomy and are assigned to unopposed therapy to those who have not had a hysterectomy and are assigned to combined estrogen and progestin therapy;
- Quantify the efficacy of HRT in reducing the age-associated decline in global cognitive functioning separately in women who have had a hysterectomy and are assigned to unopposed therapy to those who have not had a hysterectomy and are assigned to combined estrogen and progestin therapy;
- Describe the effects of HRT on all-cause dementia in subgroups defined by age, ethnicity, and clinical site;
- Describe the incidence of Alzheimer's disease and other subtypes of dementia in the WHIMS cohort;
- Describe the effects of HRT on the progression of symptoms associated with dementia in women with all-cause and Alzheimer's-type dementia.
Overview
- Acronym
- WHIMS
- Investigators
-
- Contacts
-
General Design
- Study design
- Clinical trial
- Start - End Year
- 1996 - 2004
- General Information on Follow Up (profile, frequency)
-
The participants were followed-up annually.
- Recruitment Target
-
- Individuals
- Number of Participants
- 7,479
- Number of Participants with Biological Samples
- 7,479
- Supplementary information about number of participants
-
Participants enrolled in the estrogen plus progesterone trial: 4532
Paticipants enrolled in the estrogen alone trial: 2947
- Supplementary Information
-
WHIMS was a double-blind, placebo-controlled, clinical trial.
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
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Marker Paper
Shumaker SA, Reboussin BA, Espeland MA, et al. The Women's Health Initiative Memory Study (WHIMS): a trial of the effect of estrogen therapy in preventing andslowing the progression of dementia. Controlled clinical trials, 1998; 19(6): 604-21.
PUBMED 9875839Timeline
Populations
The participants randomized in the placebo group were women, with or without a uterus, enrolled in the HRT trial of the WHI, who were aged 65 to 79 years at the time of WHIMS enrollment in 1996-1998.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
65
- Maximum age
-
79
- Countries
-
- United States of America
- Other Criteria
-
To participate, a women had to be postmenopausal and free from probable dementia at baseline.
Sources of Recruitment
- Participants from Existing Studies
-
- Women's Health Initiative (WHI)
- Supplementary Information
-
Most clinical centers used multiple recruitment strategies for WHI, with mass mailings being primary method of identifying potential participants for screening. Other strategies included: community presentations, local newspaper ads and articles, public service announcements (TV and radio), and health fairs.
Sample Size
- Number of Participants
- 3,786
- Number of Participants with Biological Samples
- 3,786
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | WHIMS - Baseline |
|
|
1996 | 1998 |
| 1 | WHIMS - Follow-up |
|
|
1997 | 2002 |
The participants randomized in the estrogen hormone therapy group (conjugated equine estrogens 0.625 mg/day) were hysterectomized women, enrolled in the HRT trial of the WHI, who were aged 65 to 79 years at the time of WHIMS enrollment in 1996-1998.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
65
- Maximum age
-
79
- Countries
-
- United States of America
- Other Criteria
-
To participate, a women had to be postmenopausal and hysterectomized and free from probable dementia at baseline.
Sources of Recruitment
- Participants from Existing Studies
-
- Women's Health Initiative (WHI)
- Supplementary Information
-
Most clinical centers used multiple recruitment strategies for WHI, with mass mailings being primary method of identifying potential participants for screening. Other strategies included: community presentations, local newspaper ads and articles, public service announcements (TV and radio), and health fairs.
Sample Size
- Number of Participants
- 1,464
- Number of Participants with Biological Samples
- 1,464
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | WHIMS - Baseline |
|
|
1996 | 1998 |
| 1 | WHIMS - Follow-up |
|
|
1997 | 2002 |
The participants randomized in the estrogen plus progesterone hormone therapy group (conjugated equine estrogens 0.625 mg/day and medroxyprogesterone acetate 2.5 mg/day) were women, with a uterus, enrolled in the HRT trial of the WHI, who were aged 65 to 79 years at the time of WHIMS enrollment in 1996-1998.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
65
- Maximum age
-
79
- Countries
-
- United States of America
- Other Criteria
-
To participate, a women had to be postmenopausal with an intact uterus and free from probable dementia at baseline.
Sources of Recruitment
- Participants from Existing Studies
-
- Women's Health Initiative (WHI)
- Supplementary Information
-
Most clinical centers used multiple recruitment strategies for WHI, with mass mailings being primary method of identifying potential participants for screening. Other strategies included: community presentations, local newspaper ads and articles, public service announcements (TV and radio), and health fairs.
Sample Size
- Number of Participants
- 2,229
- Number of Participants with Biological Samples
- 2,229
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | WHIMS - Baseline |
|
|
1996 | 1998 |
| 1 | WHIMS - Follow-up |
|
|
1997 | 2002 |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
Areas of Information Collected per per Population and Data Collection Event
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|