Women's Health Initiative Study of Cognitive Aging (WHISCA)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2008 by Wake Forest University.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Wake Forest University

ClinicalTrials.gov Identifier:

NCT00631332

First received: February 28, 2008

Last updated: NA

Last verified: February 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 28, 2008
Last Updated Date	February 28, 2008
Start Date ^ICMJE	July 1999
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 28, 2008)	Does 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. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 28, 2008)	To 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 lift of the study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Women's Health Initiative Study of Cognitive Aging
Official Title ^ICMJE	Effects of Hormone Replacement Therapy on Cognitive Aging: Women's Health Initiative Study of Cognitive Aging (WHISCA)
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. 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?
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	2303
Estimated Completion Date	June 2008
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	65 Years to 90 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00631332
Other Study ID Numbers ^ICMJE	NO1-AG-9-2115
Has Data Monitoring Committee	Yes
Responsible Party	National Institute of Health/National Institute of Aging
Study Sponsor ^ICMJE	Wake Forest University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Wake Forest University
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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