NCT00631332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 6, 2017

Status Verified

June 1, 2017

Enrollment Period

8.2 years

First QC Date

February 28, 2008

Last Update Submit

November 2, 2017

Conditions

Healthy

Keywords

women, dementia, cognition.non-demented women at least age 65

Outcome Measures

Primary Outcomes (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.

    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.

    Annual assessment done annually.

Secondary Outcomes (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.

    measured over life of the study

Eligibility Criteria

Age65 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Enrolled in WHIMS
  • At least 65 years old
  • Not diagnosed with dementia

You may not qualify if:

  • Women younger than 65 years of age
  • Have dementia
  • not enrolled in WHIMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (9)

  • Ammann EM, Pottala JV, Harris WS, Espeland MA, Wallace R, Denburg NL, Carnahan RM, Robinson JG. omega-3 fatty acids and domain-specific cognitive aging: secondary analyses of data from WHISCA. Neurology. 2013 Oct 22;81(17):1484-91. doi: 10.1212/WNL.0b013e3182a9584c. Epub 2013 Sep 25.

    PMID: 24068783BACKGROUND

  • Goveas JS, Espeland MA, Hogan PE, Tindle HA, Shih RA, Kotchen JM, Robinson JG, Barnes DE, Resnick SM. Depressive Symptoms and Longitudinal Changes in Cognition: Women's Health Initiative Study of Cognitive Aging. J Geriatr Psychiatry Neurol. 2014 Jun;27(2):94-102. doi: 10.1177/0891988714522697. Epub 2014 Feb 28.

    PMID: 24584465BACKGROUND

  • Driscoll I, Espeland MA, Wassertheil-Smoller S, Gaussoin SA, Ding J, Granek IA, Ockene JK, Phillips LS, Yaffe K, Resnick SM; Women's Health Initiative Study of Cognitive Aging. Weight change and cognitive function: findings from the Women's Health Initiative Study of Cognitive Aging. Obesity (Silver Spring). 2011 Aug;19(8):1595-600. doi: 10.1038/oby.2011.23. Epub 2011 Mar 10.

    PMID: 21394095BACKGROUND

  • Resnick SM, Coker LH, Maki PM, Rapp SR, Espeland MA, Shumaker SA. The Women's Health Initiative Study of Cognitive Aging (WHISCA): a randomized clinical trial of the effects of hormone therapy on age-associated cognitive decline. Clin Trials. 2004;1(5):440-50. doi: 10.1191/1740774504cn040oa.

    PMID: 16279282BACKGROUND

  • Espeland MA, Coker LH, Wallace R, Rapp SR, Resnick SM, Limacher M, Powell LH, Messina CR; Women's Health Initiative Study of Cognitive Aging. Association between alcohol intake and domain-specific cognitive function in older women. Neuroepidemiology. 2006;27(1):1-12. doi: 10.1159/000093532. Epub 2006 May 24.

    PMID: 16717476BACKGROUND

  • Resnick SM, Maki PM, Rapp SR, Espeland MA, Brunner R, Coker LH, Granek IA, Hogan P, Ockene JK, Shumaker SA; Women's Health Initiative Study of Cognitive Aging Investigators. Effects of combination estrogen plus progestin hormone treatment on cognition and affect. J Clin Endocrinol Metab. 2006 May;91(5):1802-10. doi: 10.1210/jc.2005-2097. Epub 2006 Mar 7.

    PMID: 16522699BACKGROUND

  • Resnick SM, Espeland MA, An Y, Maki PM, Coker LH, Jackson R, Stefanick ML, Wallace R, Rapp SR; Women's Health Initiative Study of Cognitive Aging Investigators. Effects of conjugated equine estrogens on cognition and affect in postmenopausal women with prior hysterectomy. J Clin Endocrinol Metab. 2009 Nov;94(11):4152-61. doi: 10.1210/jc.2009-1340. Epub 2009 Oct 22.

    PMID: 19850684BACKGROUND

  • Espeland MA, Miller ME, Goveas JS, Hogan PE, Coker LH, Williamson J, Naughton M, Resnick SM; Whisca Study Group. Cognitive function and fine motor speed in older women with diabetes mellitus: results from the women's health initiative study of cognitive aging. J Womens Health (Larchmt). 2011 Oct;20(10):1435-43. doi: 10.1089/jwh.2011.2812. Epub 2011 Aug 5.

    PMID: 21819251BACKGROUND

  • Espeland MA, Brunner RL, Hogan PE, Rapp SR, Coker LH, Legault C, Granek I, Resnick SM; Women's Health Initiative Study of Cognitive Aging Study Group. Long-term effects of conjugated equine estrogen therapies on domain-specific cognitive function: results from the Women's Health Initiative study of cognitive aging extension. J Am Geriatr Soc. 2010 Jul;58(7):1263-71. doi: 10.1111/j.1532-5415.2010.02953.x.

    PMID: 20649689RESULT

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sally Shumaker, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

July 1, 1999

Primary Completion

September 1, 2007

Study Completion

June 1, 2008

Last Updated

November 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)