Healthy
Conditions
Keywords
women, dementia, cognition., non-demented women at least age 65
Brief summary
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
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?
Interventions
None listed
Sponsors
Wake Forest University
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Outcome results
None listed