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DementiaWHIMS-ECHONCT00745056

Examining the Relationship Between Hormone Therapy (HT) and Cognitive Function (The WHIMS-ECHO Study)

An observational study of Dementia, run by Wake Forest University Health Sciences 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

This is a prospective, observational study of the cohort of older post-menopausal participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials. Annual cognitive assessments and ascertainment of cognitive impairment enable the continued monitoring of long-term effects of randomization to… Read more about this study

Who is it for?
Ages 65 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Dementia
How many people
2,922 participants
Where
1 siteUnited States
Study dates
11 Sep 2008to 4 Nov 2021
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Older adult

Study population: Participants will include women who participated in the WHIMS study.

Who may be able to join

  • Participated in the WHIMS study

Who cannot join

  • Non-English speaking
  • Hearing Impaired

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes

This is a prospective, observational study of the cohort of older post-menopausal participants in the WHI Memory Study, a sub-cohort of participants in the WHI Hormone Trials. Annual cognitive assessments and ascertainment of cognitive impairment enable the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive vulnerability and resilience in older women.

Read the detailed description

Identification of the predictors of cognitive impairment and cognitive resilience among aging women is important because the incidence of mild cognitive impairment (MCI) and dementia increases with age and women live the longest. The Women's Health Initiative Memory Study examined the impact of randomization to hormone therapy (conjugated equine estrogen alone or in combination with medroxyprogesterone vs. placebo) in a subset of participants aged 65-79 years at enrollment into WHI and the WHI Hormone Trials. WHIMS revealed an increased risk of all-cause dementia and MCI plus poorer global cognitive function among women randomized to HT compared to those receiving placebo. WHIMS ECHO is a prospective, observational study of the remaining cohort of WHIMS participants following cessation of treatment. Annual cognitive assessments of learning, attention, memory, working memory, executive function and language are conducted by telephone by trained staff and adjudication of incident cognitive impairment (MCI and dementia) continues. This enables the continued monitoring of long-term effects of randomization to HT on cognition and identification of predictors of cognitive aging and resilience in older women.

Conditions
Dementia
Keywords
Cognition, Memory, Hormone Therapy, HT
Medical subject headings
Dementia

What is being measured

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

  1. All-cause dementia and Mild Cognitive Impairment

    Measured: Measured annually

Secondary outcomes (1)

  1. Global and domain specific cognitive function

    Measured: Measured annually

Timeline

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

  1. First posted1 Sep 2008 (estimated)
  2. Study start11 Sep 2008
  3. Primary completion4 Nov 2021
  4. Study completion4 Nov 2021

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
Cohort
Time perspective
Prospective
Enrolment
2,922 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00745056
Sponsor's protocol ID
BG04-310
Acronym
WHIMS-ECHO
Status last verified
Apr 2021
First submitted
29 Aug 2008
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: WHIMS-ECHO will follow guidelines, methods and processes as set forth in the WHI 2015-2020 Data Sharing Plan. Limited data sets will be archived on the WHIMS-ECHO website. 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

  • Shumaker SA, Legault C, Rapp SR, Thal L, Wallace RB, Ockene JK, Hendrix SL, Jones BN 3rd, Assaf AR, Jackson RD, Kotchen JM, Wassertheil-Smoller S, Wactawski-Wende J; WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003 May 28;289(20):2651-62. doi: 10.1001/jama.289.20.2651.

    PubMed 12771112

  • Vaughan L, Erickson KI, Espeland MA, Smith JC, Tindle HA, Rapp SR. Concurrent and longitudinal relationships between cognitive activity, cognitive performance, and brain volume in older adult women. J Gerontol B Psychol Sci Soc Sci. 2014 Nov;69(6):826-36. doi: 10.1093/geronb/gbu109. Epub 2014 Sep 10.

    PubMed 25209372

  • Gaussoin SA, Espeland MA, Absher J, Howard BV, Jones BM, Rapp SR. Ascertaining dementia-related outcomes for deceased or proxy-dependent participants: an overview of the Women's Health Initiative Memory Study supplemental case ascertainment protocol. Int J Geriatr Psychiatry. 2012 Feb;27(2):205-14. doi: 10.1002/gps.2714. Epub 2011 Mar 18.

    PubMed 21416508

  • Voytko ML. Women's cognitive health special edition. Age (Dordr). 2009 Sep;31(3):189-90. doi: 10.1007/s11357-009-9090-7. Epub 2009 Mar 10. No abstract available.

    PubMed 19277900

  • Vaughan L, Leng I, Dagenbach D, Resnick SM, Rapp SR, Jennings JM, Brunner RL, Simpson SL, Beavers DP, Coker LH, Gaussoin SA, Sink KM, Espeland MA. Intraindividual variability in domain-specific cognition and risk of mild cognitive impairment and dementia. Curr Gerontol Geriatr Res. 2013;2013:495793. doi: 10.1155/2013/495793. Epub 2013 Dec 22.

    PubMed 24454359

  • Haring B, Leng X, Robinson J, Johnson KC, Jackson RD, Beyth R, Wactawski-Wende J, von Ballmoos MW, Goveas JS, Kuller LH, Wassertheil-Smoller S. Cardiovascular disease and cognitive decline in postmenopausal women: results from the Women's Health Initiative Memory Study. J Am Heart Assoc. 2013 Dec 18;2(6):e000369. doi: 10.1161/JAHA.113.000369.

    PubMed 24351701

  • Rossom RC, Espeland MA, Manson JE, Dysken MW, Johnson KC, Lane DS, LeBlanc ES, Lederle FA, Masaki KH, Margolis KL. Calcium and vitamin D supplementation and cognitive impairment in the women's health initiative. J Am Geriatr Soc. 2012 Dec;60(12):2197-205. doi: 10.1111/jgs.12032. Epub 2012 Nov 23.

    PubMed 23176129

  • Goveas JS, Hogan PE, Kotchen JM, Smoller JW, Denburg NL, Manson JE, Tummala A, Mysiw WJ, Ockene JK, Woods NF, Espeland MA, Wassertheil-Smoller S. Depressive symptoms, antidepressant use, and future cognitive health in postmenopausal women: the Women's Health Initiative Memory Study. Int Psychogeriatr. 2012 Aug;24(8):1252-64. doi: 10.1017/S1041610211002778. Epub 2012 Feb 3.

    PubMed 22301077

  • Haan M, Espeland MA, Klein BE, Casanova R, Gaussoin SA, Jackson RD, Millen AE, Resnick SM, Rossouw JE, Shumaker SA, Wallace R, Yaffe K; Women's Health Initiative Memory Study and the Women's Health Initiative Sight Exam. Cognitive function and retinal and ischemic brain changes: the Women's Health Initiative. Neurology. 2012 Mar 27;78(13):942-9. doi: 10.1212/WNL.0b013e31824d9655. Epub 2012 Mar 14.

    PubMed 22422889

  • Shih RA, Ghosh-Dastidar B, Margolis KL, Slaughter ME, Jewell A, Bird CE, Eibner C, Denburg NL, Ockene J, Messina CR, Espeland MA. Neighborhood socioeconomic status and cognitive function in women. Am J Public Health. 2011 Sep;101(9):1721-8. doi: 10.2105/AJPH.2011.300169. Epub 2011 Jul 21.

    PubMed 21778482

  • Goveas JS, Espeland MA, Woods NF, Wassertheil-Smoller S, Kotchen JM. Depressive symptoms and incidence of mild cognitive impairment and probable dementia in elderly women: the Women's Health Initiative Memory Study. J Am Geriatr Soc. 2011 Jan;59(1):57-66. doi: 10.1111/j.1532-5415.2010.03233.x.

    PubMed 21226676

  • Kerwin DR, Gaussoin SA, Chlebowski RT, Kuller LH, Vitolins M, Coker LH, Kotchen JM, Nicklas BJ, Wassertheil-Smoller S, Hoffmann RG, Espeland MA; Women's Health Initiative Memory Study. Interaction between body mass index and central adiposity and risk of incident cognitive impairment and dementia: results from the Women's Health Initiative Memory Study. J Am Geriatr Soc. 2011 Jan;59(1):107-12. doi: 10.1111/j.1532-5415.2010.03219.x.

    PubMed 21226681

  • Rapp SR, Legault C, Henderson VW, Brunner RL, Masaki K, Jones B, Absher J, Thal L. Subtypes of mild cognitive impairment in older postmenopausal women: the Women's Health Initiative Memory Study. Alzheimer Dis Assoc Disord. 2010 Jul-Sep;24(3):248-55. doi: 10.1097/WAD.0b013e3181d715d5.

    PubMed 20473134

  • Atkinson HH, Rapp SR, Williamson JD, Lovato J, Absher JR, Gass M, Henderson VW, Johnson KC, Kostis JB, Sink KM, Mouton CP, Ockene JK, Stefanick ML, Lane DS, Espeland MA. The relationship between cognitive function and physical performance in older women: results from the women's health initiative memory study. J Gerontol A Biol Sci Med Sci. 2010 Mar;65(3):300-6. doi: 10.1093/gerona/glp149. Epub 2009 Sep 29.

    PubMed 19789197

  • Coker LH, Espeland MA, Rapp SR, Legault C, Resnick SM, Hogan P, Gaussoin S, Dailey M, Shumaker SA. Postmenopausal hormone therapy and cognitive outcomes: the Women's Health Initiative Memory Study (WHIMS). J Steroid Biochem Mol Biol. 2010 Feb 28;118(4-5):304-10. doi: 10.1016/j.jsbmb.2009.11.007. Epub 2009 Nov 22.

    PubMed 19932751

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia, run by Wake Forest University Health Sciences 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 1 inclusion and 2 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 4 Apr 2023. 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?

All-cause dementia and Mild Cognitive Impairment (time frame: Measured 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 NCT00745056, which also lists 20 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 4 Apr 2023.

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