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

Dementia Clinical Trial

— WHIMS-ECHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745056
• Other study ID #: BG04-310
• Status: Completed
• Start date: September 11, 2008
• Est. completion date: November 4, 2021

Study information

• Verified date: April 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 HT on cognition and identification of predictors of cognitive vulnerability and resilience in older women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2922
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Participated in the WHIMS study

Exclusion Criteria

• Non-English speaking

• Hearing Impaired

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (19)

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: — View Citation

Chen JC, Brunner RL, Ren H, Wassertheil-Smoller S, Larson JC, Levine DW, Allison M, Naughton MJ, Stefanick ML. Sleep duration and risk of ischemic stroke in postmenopausal women. Stroke. 2008 Dec;39(12):3185-92. doi: 10.1161/STROKEAHA.108.521773. Epub 200 — View Citation

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): — View Citation

Colenda CC, Legault C, Rapp SR, DeBon MW, Hogan P, Wallace R, Hershey L, Ockene J, Whitmer R, Phillips LS, Sarto GE. Psychiatric disorders and cognitive dysfunction among older, postmenopausal women: results from the Women's Health Initiative Memory Study — View Citation

Espeland MA, Tindle HA, Bushnell CA, Jaramillo SA, Kuller LH, Margolis KL, Mysiw WJ, Maldjian JA, Melhem ER, Resnick SM; Women's Health Initiative Memory Study. Brain volumes, cognitive impairment, and conjugated equine estrogens. J Gerontol A Biol Sci Me — View Citation

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. — View Citation

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. — View Citation

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 Hea — View Citation

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 — View Citation

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 Initiativ — View Citation

Johnson KC, Margolis KL, Espeland MA, Colenda CC, Fillit H, Manson JE, Masaki KH, Mouton CP, Prineas R, Robinson JG, Wassertheil-Smoller S; Women's Health Initiative Memory Study and Women's Health Initiative Investigators. A prospective study of the effe — View Citation

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 — View Citation

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: — View Citation

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. — View Citation

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/A — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause dementia and Mild Cognitive Impairment		Measured annually
Secondary	Global and domain specific cognitive function		Measured annually