Women's Health Initiative Study of Cognitive Aging (WHISCA)
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|ClinicalTrials.gov Identifier: NCT00631332|
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : November 6, 2017
|Condition or disease|
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.
- 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?
|Study Type :||Observational|
|Actual Enrollment :||2303 participants|
|Official Title:||Effects of Hormone Replacement Therapy on Cognitive Aging: Women's Health Initiative Study of Cognitive Aging (WHISCA)|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||June 2008|
- 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. [ Time Frame: Annual assessment done 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.
- 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. [ Time Frame: measured over life of the study ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631332
|United States, North Carolina|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Sally Shumaker, PhD||Wake Forest University Health Sciences|