The Women's Health Initiative Memory Study (The WHIMS Study)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dementia Syndromes |
Drug: Estrogen horomone therapy Drug: Estrogen plus progesterone hormone therapy Drug: Placebo |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Women's Health Initiative Memory Study |
- All-cause dementia [ Time Frame: Measured annually for 6 years ] [ Designated as safety issue: No ]
- Mild cognitive impairment [ Time Frame: Measured annually for 6 years ] [ Designated as safety issue: No ]
| Enrollment: | 7525 |
| Study Start Date: | January 1996 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | September 1997 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Women from the WHI study taking hormone replacement therapy with estrogen alone
|
Drug: Estrogen horomone therapy
Estrogen pill daily
|
|
2
Women from the WHI study taking hormone replacement therapy with both estrogen and progesterone
|
Drug: Estrogen plus progesterone hormone therapy
Estrogen plus progesterone hormone therapy pill (Prempro) daily
Other Name: Prempro
|
|
3
Women from the WHI study taking placebo
|
Drug: Placebo
Placebo pill daily
|
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| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
This study will include participants from the hormone replacement therapy trial of the WHI study.
Inclusion Criteria:
- Enrolled in the WHI study
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Sally A. Shumaker, PhD | Wake Forest University |
More Information
Publications:
| Responsible Party: | Sally A. Shumaker/Senior Associate Dean, Research, Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00685009 History of Changes |
| Other Study ID Numbers: | 548, N01-WH44221 |
| Study First Received: | May 23, 2008 |
| Last Updated: | June 13, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Cognition Memory Hormone Therapy |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Estrogens |
Hormones Progesterone Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Progestins |
ClinicalTrials.gov processed this record on May 16, 2013