The Women's Health Initiative Memory Study (The WHIMS Study)
Information source: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dementia Syndromes
Intervention: Estrogen horomone therapy (Drug); Estrogen plus progesterone hormone therapy (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s): Sally A. Shumaker, PhD, Principal Investigator, Affiliation: Wake Forest School of Medicine
Summary
Excessive memory decline or dementia affects an increasing number of women as they become
older. The frequency of dementia doubles every 5 years beginning at age 60, making the
discovery of ways to prevent or slow the disease imperative. Previous studies have indicated
that changes in memory may be associated with the female hormonal decline that occurs after
menopause, but more research is needed to establish the link between menopause and poorer
memory function. It is believed that taking the female hormones estrogen and/or progesterone
may help improve women's health by protecting against memory decline. This study will
evaluate the effects of female hormone replacement therapy (HRT) on the development and
progression of memory loss in older women enrolled in the Women's Health Initiative (WHI)
study.
Clinical Details
Official title: Women's Health Initiative Memory Study
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: All-cause dementia
Secondary outcome: Mild cognitive impairment
Detailed description:
Diseases of the memory, including dementia and Alzheimer's disease, are a primary health
concern of the aging population. In just the last 30 years, the number of Americans
diagnosed with memory diseases has doubled. The beginning signs and symptoms of Alzheimer's
and dementia include mild forgetfulness, confusion, and disorientation with time and place.
As the diseases advance, people often experience difficulty in carrying out normal
activities, recognizing family and friends, and eventually speaking and comprehending. Early
identification and treatment for dementia and Alzheimer's may help prevent and slow the
progression of symptoms, but the most beneficial means of treatment is still unknown.
Previous studies have suggested a link between menopause and reduced memory function in
women, possibly attributed to the dramatic decline in the levels of the female hormones
estrogen and progesterone. HRT in postmenopausal women may help to curb memory loss and
reduce risk of developing memory-related diseases. This study will evaluate the effects of
female HRT on the development and progression of memory loss in older women enrolled in the
WHI study.
Participants in this study will be drawn from the WHI study and will have previously been
assigned to HRT with estrogen, HRT with estrogen plus progesterone, or placebo. During this
study, participants will continue to take their assigned treatments from the WHI study.
Participation will last up to 6 years. All participants will undergo baseline memory and
thinking tests, including a mood assessment and tasks measuring memory and other brain
functions. Study staff will conduct a telephone interview with a close family member or
friend. Some participants may additionally undergo a 45-minute interview with a clinician, a
blood draw, and a computerized tomography (CT) scan. All participants will repeat the
baseline memory and thinking tests once annually for 6 years, and some participants will
repeat the interview, blood draw, and CT scan at these annual visits as well.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Enrolled in the WHI study
Locations and Contacts
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States
Additional Information
Related publications: Shumaker SA, Reboussin BA, Espeland MA, Rapp SR, McBee WL, Dailey M, Bowen D, Terrell T, Jones BN. The Women's Health Initiative Memory Study (WHIMS): a trial of the effect of estrogen therapy in preventing and slowing the progression of dementia. Control Clin Trials. 1998 Dec;19(6):604-21.
Starting date: January 1996
Last updated: June 13, 2008
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