Women's Health Initiative Study of Cognitive Aging

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.

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Key information

Conditions

Healthy Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

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

Acronym: WHISCA

Important dates

Study start: 1999
Primary completion: 2007
Study completion: 2008
First posted: Mar 7, 2008
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed