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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stephen R. Rapp, Wake Forest Baptist Health Identifier:
First received: August 29, 2008
Last updated: June 1, 2015
Last verified: June 2015
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.


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 Wake Forest University Health Sciences:

Primary Outcome Measures:
  • All-cause dementia [ Time Frame: Measured annually ]

Secondary Outcome Measures:
  • Mild cognitive impairment [ Time Frame: Measured annually ]

Enrollment: 2922
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.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants will include women who participated in the WHIMS study.

Inclusion Criteria:

  • Participated in the WHIMS study

Exclusion Criteria

  • Non-English speaking
  • Hearing Impaired
  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 identifier: NCT00745056

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Principal Investigator: Stephen R. Rapp, PhD Wake Forest University Health Sciences
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephen R. Rapp, Professor, Wake Forest Baptist Health Identifier: NCT00745056     History of Changes
Other Study ID Numbers: 1436 
Study First Received: August 29, 2008
Last Updated: June 1, 2015

Keywords provided by Wake Forest University Health Sciences:
Hormone Therapy

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders processed this record on February 24, 2017