Skip to content

The Women's Health Initiative Memory Study (The WHIMS Study)

Women's Health Initiative Memory Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00685009
Enrollment
7525
Registered
2008-05-28
Start date
1996-01-31
Completion date
2008-03-31
Last updated
2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia Syndromes

Keywords

Cognition, Memory, Hormone Therapy

Brief 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.

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.

Interventions

DRUGEstrogen hormone therapy

Estrogen pill daily

DRUGEstrogen plus progesterone hormone therapy

Estrogen plus progesterone hormone therapy pill (Prempro) daily

DRUGPlacebo

Placebo pill daily

Sponsors

Wake Forest University Health Sciences
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

* Enrolled in the Women's Health Initiative - Hormone Therapy Trial * Aged 65 - 79 years of age at time of enrollment

Design outcomes

Primary

MeasureTime frame
All-cause dementiaMeasured annually for 6 years

Secondary

MeasureTime frame
Mild cognitive impairmentMeasured annually for 6 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026