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HealthyWHISCANCT00631332

Women's Health Initiative Study of Cognitive Aging

An observational study of Healthy, run by Wake Forest University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
2,303 participants
Where
1 siteUnited States
Study dates
Jul 1999to Jun 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • Women only
  • Healthy volunteers accepted
  • Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the 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?
Conditions
Healthy
Keywords
women, dementia, cognition., non-demented women at least age 65
Medical subject headings
Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Annual assessment done annually.

Secondary outcomes (1)

  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.

    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.

    Measured: measured over life of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2008 (estimated)
  2. Study startJul 1999
  3. Primary completionSep 2007
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
2,303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00631332
Sponsor's protocol ID
NO1-AG-9-2115
Acronym
WHISCA
Status last verified
Jun 2017
First submitted
28 Feb 2008
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 24068783

  • 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.

    PubMed 24584465

  • 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.

    PubMed 21394095

  • 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.

    PubMed 16279282

  • 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.

    PubMed 16717476

  • 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.

    PubMed 16522699

  • 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.

    PubMed 19850684

  • 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.

    PubMed 21819251

  • 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.

    PubMed 20649689

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Wake Forest University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00631332, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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