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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
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Description
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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.

Condition or disease
Healthy

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?
Study Design
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Study Type : Observational
Actual Enrollment : 2303 participants
Observational Model: Other
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A subset of women who were enrolled in the Women's Health Initiative Memory Study (WHIMS), who are at least 65 years old and not diagnosed with any type of dementia.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
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Principal Investigator: Sally Shumaker, PhD Wake Forest University Health Sciences
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00631332    
Other Study ID Numbers: NO1-AG-9-2115
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: WHISCA will follow guidelines, methods and processes as set forth in the WHI 2015-2020 Data Sharing Plan. Accompanying the limited data sets, substantial electronic documentation will be provided in a standard format that is readable on a variety of platforms. Documentation will include data collection forms, a description of study protocol and procedures, description of all variable re-coding and a list of major study publications. These data will be available to users only under a data-sharing agreement that provides for: a commitment to using the data only for research purposes and not to identify any individual participant; a commitment to securing the data using appropriate computer technology; and a commitment to destroying or returning the data after analyses are completed. Data will be made available for timely release no later than the acceptance for publication of the main findings from the final dataset.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
women, dementia, cognition.
non-demented women at least age 65