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Trial record 4 of 95 for:    women's health initiative

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00745056
First received: August 29, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The prevalence of illnesses associated with old age, including dementia, is rising significantly as the elderly population dramatically grows. The use of hormone therapy (HT) after menopause may increase the risk of dementia and cognitive decline, but more research is needed to confirm this link. This study will examine the incidence of dementia and cognitive decline in older women who participated in the Women's Health Initiative Memory Study (WHIMS), a study in which women received HT after menopause.


Condition
Dementia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • All-cause dementia [ Time Frame: Measured annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mild cognitive impairment [ Time Frame: Measured annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: August 2008
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Dementia is an illness characterized by a progressive decline in cognitive function. People with this disease experience memory, behavior, learning, and communication problems. The prevalence of dementia and other age-associated cognitive disorders is rising dramatically in the United States and around the world as the elderly population grows, and many of these affected individuals require assisted living and other costly forms of medical and personal care. As women go through menopause, many choose to take HT to relieve common menopausal symptoms, including hot flashes and mood swings. Unfortunately, the use of HT may place women at higher risk of experiencing a decline in cognitive function and at an increased risk of dementia, even after stopping HT. In the WHIMS study, women received HT, either as estrogen alone or as estrogen and progesterone combined, or placebo. This study will examine WHIMS participants to assess the prevalence of dementia and cognitive decline as these women grow older. Study researchers will attempt to determine whether HT increases the risk of dementia.

This study will enroll women who are participating in the WHIMS study. Participants will be contacted by telephone annually; there will be no in-person study visits. Study staff will conduct interviews and administer questionnaires to participants to assess cognitive function, memory, attention, executive function, verbal fluency, depression, sleep disturbance, and dementia characteristics.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Participants will include women who participated in the WHIMS study.

Criteria

Inclusion Criteria:

  • Participated in the WHIMS study
  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: NCT00745056

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Investigators
Principal Investigator: Sally A. Shumaker, PhD Wake Forest School of Medicine
  More Information

Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00745056     History of Changes
Other Study ID Numbers: 1436
Study First Received: August 29, 2008
Last Updated: October 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Cognition
Memory
Hormone Therapy
HT

ClinicalTrials.gov processed this record on November 25, 2014