The Women's Health Initiative Memory Study (The WHIMS Study)
Condition: Dementia Syndromes
MeSH terms: Dementia
Study type: Observational

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.
    

Intervention name(s): Estrogen hormone therapy; Estrogen plus progesterone hormone therapy; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Estrogen pill daily; Estrogen plus progesterone hormone therapy pill (Prempro) daily; Placebo pill daily
Other intervention name(s): Premarin; Prempro
Intervention MeSH terms: Hormones; Progesterone; Estrogens
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include participants from the hormone therapy trial of the WHI study.
      
Keywords: Cognition; Memory; Hormone Therapy