Women’s Health Initiative Study of Cognitive Aging
The goal of WHISCA was to determine the effect of hormone therapy on age-related declines in cognition in women 65 years and older who had not received diagnoses of dementia.
Secondary goals of WHISCA were to:
- Determine the rates of change in memory and other cognitive functions in a large cohort of elderly women and in subgroups defined by age, ethnicity and cognitive function at entry;
- Identify predictors of cognitive changes;
- Identify predictors of dementia and cognitive impairment and to characterize the transition from normal aging to cognitive impairment to dementia through the interface with the WHIMS adjudicated diagnoses of probable dementia and mild cognitive impairment.
Overview
- Acronym
- WHISCA
- Investigators
-
- Contacts
-
General Design
- Study design
- Clinical trial
- Start - End Year
- 1999 - 2007
- General Information on Follow Up (profile, frequency)
-
The participants were followed-up annually.
- Recruitment Target
-
- Individuals
- Number of Participants
- 2,302
- Supplementary Information
-
WHISCA was a double-blind, placebo-controlled, clinical trial.
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Marker Papers
Resnick SM, Coker LH, Maki PM, et al. The Women's Health Initiative Study of Cognitive Aging (WHISCA): a randomized clinical trial of the effects of hormone therapy on age-associated cognitive decline. Clinical trials, 2004; 1(5): 440-50.
PUBMED 16279282Timeline
Populations
The participants in the estrogen hormone therapy group (conjugated equine estrogens 0.625mg/day) were hysterectomized women, enrolled in the WHIMS study and the HRT trial of the WHI, who were aged 66 to 84 years at the time of WHISCA enrollment in 1999-2001.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
66
- Maximum age
-
84
- Countries
-
- United States of America
- Other Criteria
-
To participate, a woman had to be postmenopausal and hysterectomized and free from probable dementia.
Sources of Recruitment
- Participants from Existing Studies
-
- Women's Health Initiative Memory Study (WHIMS), Women's Health Initiative (WHI)
- Supplementary Information
-
Participants to WHISCA were recruited through mailings and at WHIMS clinic visits.
Sample Size
- Number of Participants
- 434
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | WHISCA - Baseline |
|
1999 (October) | 2001 (June) | |
| 1 | WHISCA - Follow-up |
|
2000 (October) | 2007 (April) |
The participants in the placebo group were women, with or without a uterus, enrolled in the WHIMS study and the HRT trial of the WHI, who were aged 66 to 84 years at the time of WHISCA enrollment in 1999-2001.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
66
- Maximum age
-
84
- Countries
-
- United States of America
- Other Criteria
-
To participate, a woman had to be postmenopausal and free from probable dementia.
Sources of Recruitment
- Participants from Existing Studies
-
- Women's Health Initiative Memory Study (WHIMS), Women's Health Initiative (WHI)
- Supplementary Information
-
Participants to WHISCA were recruited through mailings and at WHIMS clinic visits.
Sample Size
- Number of Participants
- 1,178
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | WHISCA - Baseline |
|
1999 (October) | 2001 (June) | |
| 1 | WHISCA - Follow-up |
|
2000 (October) | 2007 (April) |
The participants 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 WHIMS study and the HRT trial of the WHI, who were aged 66 to 84 years of WHISCA enrollment in 1999-2001.
Selection Criteria
- Gender
-
Women only
- Minimum age
-
66
- Maximum age
-
84
- Countries
-
- United States of America
- Other Criteria
-
To participate, a woman had to be postmenopausal with an intact uterus and free from probable dementia.
Sources of Recruitment
- Participants from Existing Studies
-
- Women's Health Initiative Memory Study (WHIMS), Women's Health Initiative (WHI)
- Supplementary Information
-
Participants to WHISCA were recruited through mailings and at WHIMS clinic visits.
Sample Size
- Number of Participants
- 690
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | WHISCA - Baseline |
|
1999 (October) | 2001 (June) | |
| 1 | WHISCA - Follow-up |
|
2000 (October) | 2007 (April) |
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 |
|---|