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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
  Purpose

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?

Condition
Healthy

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2303
Study Start Date: July 1999
Estimated Study Completion Date: June 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631332

Locations
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
  More Information

No publications provided

Responsible Party: National Institute of Health/National Institute of Aging
ClinicalTrials.gov Identifier: NCT00631332     History of Changes
Other Study ID Numbers: NO1-AG-9-2115
Study First Received: February 28, 2008
Last Updated: February 28, 2008
Health Authority: United States: Federal Government

Keywords provided by Wake Forest University:
women, dementia, cognition.
non-demented women at least age 65

ClinicalTrials.gov processed this record on June 18, 2013