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

• ClinicalTrials.gov Identifier: NCT00685009
• Recruitment Status: Completed
• First Posted: May 28, 2008
• Last Update Posted: October 19, 2015
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborator: Wake Forest University Health Sciences
• Information provided by (Responsible Party): National Heart, Lung, and Blood Institute (NHLBI)

Study Description

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.

Condition or disease	Intervention/treatment
Dementia Syndromes	Drug: Estrogen hormone therapy; Drug: Estrogen plus progesterone hormone therapy; Drug: Placebo

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 7525 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Women's Health Initiative Memory Study
• Study Start Date: January 1996
• Actual Primary Completion Date: September 1997
• Actual Study Completion Date: March 2008

Groups and Cohorts

Group/Cohort	Intervention/treatment
1; Women from the Women's Health Initiative study taking estrogen hormone therapy	Drug: Estrogen hormone therapy; Estrogen pill daily; Other Name: Premarin
2; Women from the WHI study taking estrogen plus progesterone hormone therapy	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

Outcome Measures

Primary Outcome Measures :

1. All-cause dementia [ Time Frame: Measured annually for 6 years ]

Secondary Outcome Measures :

1. Mild cognitive impairment [ Time Frame: Measured annually for 6 years ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 79 Years (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Sally A. Shumaker, PhD; Wake Forest University Health Sciences

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT00685009
• Other Study ID Numbers: 548; N01-WH44221
• First Posted: May 28, 2008
• Last Update Posted: October 19, 2015
• Last Verified: October 2015

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Cognition; Memory; Hormone Therapy

Additional relevant MeSH terms:

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Hormones; Progesterone; Estrogens; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Progestins