Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm (WHIMS-Y)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Stephen R. Rapp, Wake Forest Baptist Health

ClinicalTrials.gov Identifier:

NCT01124773

First received: May 13, 2010

Last updated: June 1, 2015

Last verified: June 2015

History of Changes

Purpose

WHIMS-Y will provide the WHI information on one of the most enduring negative consequences of postmenopausal HT; a relative deficit in cognitive function and an increased risk for clinically significant cognitive impairment that remain in the cohort after the cessation of study-prescribed HT.

Condition
Dementia


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Women's Health Initiative Memory Study of Younger Women

Resource links provided by NLM:

MedlinePlus related topics: Dementia Hormones Memory Women's Health

U.S. FDA Resources

Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:

All-cause dementia [ Time Frame: Measured once a year ] [ Designated as safety issue: No ]
One time per year, participants will have a cognitive assessment administered over the telephone.

Secondary Outcome Measures:

Mild Cognitive Impairment [ Time Frame: 1 time per year ] [ Designated as safety issue: No ]
Once per year, participants will receive a cognitive assessment by telephone.


Enrollment:	1362
Study Start Date:	June 2009
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts
Previous HT use and cognition Women who were aged 50-54 at the time of randomization into the WHI hormone trials.

Detailed Description:

The Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) is proposed to assess the long-term impact of random assignment to postmenopausal hormone therapy (Medroxyprogesterone, Estrogens, Conjugated or Estrogen-only or placebo) among women who were aged 50-54 at the time of randomization into the WHI hormone trials. Secondary objectives relate to the consistency of any treatment effects across unopposed or opposed therapy and whether there exists evidence of graded relationships between cognitive effects and age of administration, years from menopause, and baseline risk factors for cognitive impairment.

Eligibility


Ages Eligible for Study:	50 Years to 54 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Women who enrolled into the HT arm of the Women's Health Initiative when age 50-54 at the time of randomization.

Criteria

Inclusion Criteria:

Must be enrolled in the Women's Health Initiative Extension

Exclusion Criteria:

Not enrolled in the Women's Health Initiative Extension

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124773

Locations


United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest Baptist Health

Investigators


Principal Investigator:	Stephen R Rapp, PhD	Wake Forest School of Medicine

More Information

Publications:

Espeland MA, Shumaker SA, Leng I, Manson JE, Brown CM, LeBlanc ES, Vaughan L, Robinson J, Rapp SR, Goveas JS, Wactawski-Wende J, Stefanick ML, Li W, Resnick SM; WHIMSY Study Group. Long-term effects on cognitive function of postmenopausal hormone therapy prescribed to women aged 50 to 55 years. JAMA Intern Med. 2013 Aug 12;173(15):1429-36.

Vaughan L, Espeland MA, Snively B, Shumaker SA, Rapp SR, Shupe J, Robinson JG, Sarto GE, Resnick SM; Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) Study Group. The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y). Brain Res. 2013 Jun 13;1514:3-11. doi: 10.1016/j.brainres.2013.03.047. Epub 2013 Apr 8.


Responsible Party:	Stephen R. Rapp, Professor, Wake Forest Baptist Health
ClinicalTrials.gov Identifier:	NCT01124773 History of Changes
Other Study ID Numbers:	699
Study First Received:	May 13, 2010
Last Updated:	June 1, 2015
Health Authority:	United States: Federal Government

Keywords provided by Wake Forest Baptist Health:


cognition memory hormone therapy

Additional relevant MeSH terms:


Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders	Mental Disorders Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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