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.
- Start Year
- 1996
- End Year
- 2004
Visit WHIMS
| Investigators | Contacts |
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Design
- Study design
- Clinical trial
- Follow Up
-
The participants were followed-up annually.
- Supplementary Information
-
WHIMS was a double-blind, placebo-controlled, clinical trial.
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 9875839
Recruitment
- Recruitment Target
-
- Individuals
Number of Participants
- Number of Participants
- 7,479
- Number of Participants with Biological Samples
- 7,479
- Supplementary Information
-
Participants enrolled in the estrogen plus progesterone trial: 4532
Paticipants enrolled in the estrogen alone trial: 2947
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
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
- Sex
-
Women
- Minimum age
-
65
- Maximum age
-
79
- Newborns
- Twins
- Countries
-
- United States of America
- Other Criteria
-
To participate, a women had to be postmenopausal and free from probable dementia at baseline.
Recruitment
- Sources of recruitment
-
- Participants from existing studies
- 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.
- Participants from Existing Studies
-
- Women's Health Initiative (WHI)
Number of Participants
- Number of Participants
- 3,786
- Number of Participants with Biological Samples
- 3,786
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
WHIMS - Baseline
|
The WHIMS measurement protocol had 4 ordered phases. Completion of phases 2 and 3 were done within 3 months of phase 1. Phase 1: The Modified Mini-Mental Exam (3MS) was administered. ... |
1996 | 1998 |
| 1 |
WHIMS - Follow-up
|
The WHIMS measurement protocol had 4 ordered phases. Completion of phases 2 and 3 were done within 3 months of phase 1. Phase 1: The Modified Mini-Mental Exam (3MS) was administered. ... |
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
- Sex
-
Women
- Minimum age
-
65
- Maximum age
-
79
- Newborns
- Twins
- Countries
-
- United States of America
- Other Criteria
-
To participate, a women had to be postmenopausal and hysterectomized and free from probable dementia at baseline.
Recruitment
- Sources of recruitment
-
- Participants from existing studies
- 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.
- Participants from Existing Studies
-
- Women's Health Initiative (WHI)
Number of Participants
- Number of Participants
- 1,464
- Number of Participants with Biological Samples
- 1,464
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
WHIMS - Baseline
|
The WHIMS measurement protocol had 4 ordered phases. Completion of phases 2 and 3 were done within 3 months of phase 1. Phase 1: The Modified Mini-Mental Exam (3MS) was administered. ... |
1996 | 1998 |
| 1 |
WHIMS - Follow-up
|
The WHIMS measurement protocol had 4 ordered phases. Completion of phases 2 and 3 were done within 3 months of phase 1. Phase 1: The Modified Mini-Mental Exam (3MS) was administered. ... |
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
- Sex
-
Women
- Minimum age
-
65
- Maximum age
-
79
- Newborns
- Twins
- 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.
Recruitment
- Sources of recruitment
-
- Participants from existing studies
- 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.
- Participants from Existing Studies
-
- Women's Health Initiative (WHI)
Number of Participants
- Number of Participants
- 2,229
- Number of Participants with Biological Samples
- 2,229
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
WHIMS - Baseline
|
The WHIMS measurement protocol had 4 ordered phases. Completion of phases 2 and 3 were done within 3 months of phase 1. Phase 1: The Modified Mini-Mental Exam (3MS) was administered. ... |
1996 | 1998 |
| 1 |
WHIMS - Follow-up
|
The WHIMS measurement protocol had 4 ordered phases. Completion of phases 2 and 3 were done within 3 months of phase 1. Phase 1: The Modified Mini-Mental Exam (3MS) was administered. ... |
1997 | 2002 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
- Cognitive functioning
- Personality
- Psychological distress and emotions
- Other psychological measures and assessments
- Tobacco
- Alcohol
- Drugs
- Nutrition
- Breastfeeding
- Physical activity
- Sleep
- Sexual behaviours and orientation
- Technological devices
- Misbehaviour and criminality
- Other and unspecified lifestyle information
Socio-demographic and economic characteristics
Lifestyle and behaviours
Diseases
Symptoms and signs
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Physical measures and assessments
Laboratory measures
Cognition, personality and psychological measures and assessments
Social environment and relationships
Administrative information
Cognitive functioning
Psychological distress and emotions
Alcohol