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

NCT ID: NCT00685009

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7525 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-01-31
• Study Completion Date: 2008-03-31

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.

Conditions

Dementia Syndromes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Women from the Women's Health Initiative study taking estrogen hormone therapy

Estrogen hormone therapy

Intervention Type: DRUG

Estrogen pill daily

2

Women from the WHI study taking estrogen plus progesterone hormone therapy

Estrogen plus progesterone hormone therapy

Intervention Type: DRUG

Estrogen plus progesterone hormone therapy pill (Prempro) daily

3

Women from the WHI study taking placebo

Placebo

Intervention Type: DRUG

Placebo pill daily

Interventions

Estrogen hormone therapy

Estrogen pill daily

Intervention Type: DRUG

Estrogen plus progesterone hormone therapy

Estrogen plus progesterone hormone therapy pill (Prempro) daily

Intervention Type: DRUG

Placebo

Placebo pill daily

Intervention Type: DRUG

Other Intervention Names

Premarin; Prempro

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally A. Shumaker, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

References

Shumaker SA, Reboussin BA, Espeland MA, Rapp SR, McBee WL, Dailey M, Bowen D, Terrell T, Jones BN. The Women's Health Initiative Memory Study (WHIMS): a trial of the effect of estrogen therapy in preventing and slowing the progression of dementia. Control Clin Trials. 1998 Dec;19(6):604-21. doi: 10.1016/s0197-2456(98)00038-5.

Reference Type: BACKGROUND

PMID: 9875839 (View on PubMed)

Harris WS, Tintle NL, Manson JE, Metherel AH, Robinson JG. Effects of menopausal hormone therapy on erythrocyte n-3 and n-6 PUFA concentrations in the Women's Health Initiative randomized trial. Am J Clin Nutr. 2021 Jun 1;113(6):1700-1706. doi: 10.1093/ajcn/nqaa443.

Reference Type: DERIVED

PMID: 33710263 (View on PubMed)

Lo K, Liu Q, Madsen T, Rapp S, Chen JC, Neuhouser M, Shadyab A, Pal L, Lin X, Shumaker S, Manson J, Feng YQ, Liu S. Relations of magnesium intake to cognitive impairment and dementia among participants in the Women's Health Initiative Memory Study: a prospective cohort study. BMJ Open. 2019 Nov 3;9(11):e030052. doi: 10.1136/bmjopen-2019-030052.

Reference Type: DERIVED

PMID: 31685499 (View on PubMed)

Haring B, Wu C, Coker LH, Seth A, Snetselaar L, Manson JE, Rossouw JE, Wassertheil-Smoller S. Hypertension, Dietary Sodium, and Cognitive Decline: Results From the Women's Health Initiative Memory Study. Am J Hypertens. 2016 Feb;29(2):202-16. doi: 10.1093/ajh/hpv081. Epub 2015 Jul 1.

Reference Type: DERIVED

PMID: 26137952 (View on PubMed)

Espeland MA, Pettinger M, Falkner KL, Shumaker SA, Limacher M, Thomas F, Weaver KE, Stefanick ML, McQuellon C, Hunt JR, Johnson KC. Demographic and health factors associated with enrollment in posttrial studies: the Women's Health Initiative Hormone Therapy Trials. Clin Trials. 2013;10(3):463-72. doi: 10.1177/1740774513477931. Epub 2013 Mar 12.

Reference Type: DERIVED

PMID: 23480899 (View on PubMed)

Other Identifiers

N01WH44221

Identifier Type: NIH

Identifier Source: secondary_id

View Link

548

Identifier Type: -

Identifier Source: org_study_id