Official Title: “Women's Health Initiative Memory Study”

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.

Study Type: Observational

Study Design: Case Control, Prospective

Study Primary Completion Date: September 1997

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.

Intervention(s) in this Clinical Trial

• Drug: Estrogen horomone therapy
  • Estrogen pill daily
• Drug: Estrogen plus progesterone hormone therapy
  • Estrogen plus progesterone hormone therapy pill (Prempro) daily
• Drug: Placebo
  • Placebo pill daily

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Women from the WHI study taking hormone replacement therapy with estrogen alone
• : 2
  • Women from the WHI study taking hormone replacement therapy with both estrogen and progesterone
• : 3
  • Women from the WHI study taking placebo

Primary Measures

• All-cause dementia
  • Time Frame: Measured annually for 6 years
    Safety Issue?: No

Secondary Measures

• Mild cognitive impairment
  • Time Frame: Measured annually for 6 years
    Safety Issue?: No

Inclusion Criteria:

• Enrolled in the WHI study

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Sally A. Shumaker, PhD Principal Investigator Wake Forest University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685009

Study ID Number: 548

ClinicalTrials.gov Identifier: NCT00685009

Health Authority: United States: Federal Government