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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00685009
First received: May 23, 2008
Last updated: June 13, 2008
Last verified: May 2008
  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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • All-cause dementia [ Time Frame: Measured annually for 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

This study will include participants from the hormone replacement therapy trial of the WHI study.

Criteria

Inclusion Criteria:

  • Enrolled in the WHI study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685009

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Investigators
Principal Investigator: Sally A. Shumaker, PhD Wake Forest School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Hormones
Progesterone
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins

ClinicalTrials.gov processed this record on October 01, 2014