Women's Health Initiative Study of Cognitive Aging

Study Overview
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Brief Summary
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The Women's Health Initiative Study of Cognitive Aging (WHISCA) is a two-armed, randomized, placebo controlled, clinical trial designed to assess the efficacy of postmenopausal hormone therapy (HT) on age related changes in specific cognitive functions.

Detailed Description
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WHISCA is an ancillary study to the Women's Health Initiative (WHI) and the WHI Memory Study (WHIMS) and has enrolled 2303 women aged 66 to 84 years who did not meet the criteria for dementia. WHISCA is investigating the effects of hormone therapy on rates of change over time in memory, other aspects of cognition (language, attention, spatial ability), motor function, and mood. Objectives Does HT protect against age-associated memory and cognitive longitudinal decline in women age 65 and older? What is the rate of change in memory and other cognitive abilities in women receiving HT compared to women receiving placebo? Does the addition of progesterone to HT modify the effects of estrogen on memory and other cognitive abilities?

Official Title
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Effects of Hormone Replacement Therapy on Cognitive Aging: Women's Health Initiative Study of Cognitive Aging (WHISCA)

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in WHIMS At least 65 years old Not diagnosed with dementia Exclusion Criteria: Women younger than 65 years of age Have dementia not enrolled in WHIMS

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if HT protect against age-associated memory and cognitive longitudinal decline in women age 65 and older as measured over time by a series of cognitive tests administered annually. | The primary outcome measures are the changes in scores from a standardized neuropsychological assessment will be conducted annually. The battery is comprised primarily of tests of memory, and includes the following tests in specified order: the Prospective Memory Tests, Primary Mental Abilities Vocabulary Test, the California Verbal Learning Test, the Benton Visual Retention Test, Card Rotations Test, the Finger Tapping Test, the Letter and Semantic Fluency Test and the Digit Span Test. In addition, the Positive and Negative Affect Scale and Geriatric Depression Scale will be administered. | Annual assessment done annually. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the long-term effects of HT on changes in memory, other cognitive functions, and affect; and to investigate predictors of the transitions between normal aging and mild cognitive impairment and mild cognitive impairment and dementia. | Secondary outcome measures will examine relative differences in measures between enrollment in WHIMS and the termination of the WHIMS E+P trial and E-Alone trial and also examine the relative differences in measures comparing periods of time for each woman when she reported taking HT versus times she reported not taking HT. | measured over life of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women, dementia, cognition., non-demented women at least age 65