Examining the Relationship Between Hormone Therapy and Cognitive Function (The WHIMS-ECHO Study)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Women's Health Initiative Memory Study--Epidemiology of Cognitive Health Outcomes|
- All-cause dementia [ Time Frame: Measured annually ] [ Designated as safety issue: No ]
- Mild cognitive impairment [ Time Frame: Measured annually ] [ Designated as safety issue: No ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745056
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Sally A. Shumaker, PhD||Wake Forest School of Medicine|