Women's Health Initiative Study of Cognitive Aging

NCT ID: NCT00631332

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2303 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-07-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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?

Conditions

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Healthy

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sally Shumaker, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24068783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24584465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21394095 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16279282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16717476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16522699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19850684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21819251 (View on PubMed)

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.

Reference Type RESULT
PMID: 20649689 (View on PubMed)

Other Identifiers

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NO1-AG-9-2115

Identifier Type: -

Identifier Source: org_study_id