Clinical trial NCT01124773: Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm
Official title: Women's Health Initiative Memory Study of Younger Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: cognition
memory
hormone therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 1362
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who enrolled into the HT arm of the Women's Health Initiative when age 50-54 at the time of randomization.

Brief summary: WHIMS-Y provides valuable information on the long-term effects on risk of cognitive impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials. Following cessation of study-prescribed HT cognitive function and impairment were assessed.

Detailed description: The Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) is proposed to assess the long-term impact of random assignment to postmenopausal hormone therapy (equine estrogen alone or in combination with medroxyprogesterone versus placebo) among women who were aged 50-54 at the time of randomization into the WHI hormone trials. Secondary objectives relate to the consistency of any treatment effects across unopposed or opposed therapy and whether there exists evidence of graded relationships between cognitive effects and age of administration, years from menopause, and baseline risk factors for cognitive impairment.

Eligibility criteria: Inclusion Criteria:

* Must be enrolled in the Women's Health Initiative Extension

Exclusion Criteria:

* Not enrolled in the Women's Health Initiative Extension

Primary outcomes:
measure: All-cause dementia and Mild Cognitive Impairment
timeFrame: Measured once a year
Secondary outcomes:
measure: Global and domain specific cognitive function.
timeFrame: Measured once a year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen R Rapp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaughan L, Espeland MA, Snively B, Shumaker SA, Rapp SR, Shupe J, Robinson JG, Sarto GE, Resnick SM; Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) Study Group. The rationale, design, and baseline characteristics of the Women's Health Initiative Memory Study of Younger Women (WHIMS-Y). Brain Res. 2013 Jun 13;1514:3-11. doi: 10.1016/j.brainres.2013.03.047. Epub 2013 Apr 8.
citation: Espeland MA, Shumaker SA, Leng I, Manson JE, Brown CM, LeBlanc ES, Vaughan L, Robinson J, Rapp SR, Goveas JS, Wactawski-Wende J, Stefanick ML, Li W, Resnick SM; WHIMSY Study Group. Long-term effects on cognitive function of postmenopausal hormone therapy prescribed to women aged 50 to 55 years. JAMA Intern Med. 2013 Aug 12;173(15):1429-36. doi: 10.1001/jamainternmed.2013.7727.
citation: Espeland MA, Rapp SR, Manson JE, Goveas JS, Shumaker SA, Hayden KM, Weitlauf JC, Gaussoin SA, Baker LD, Padula CB, Hou L, Resnick SM; WHIMSY and WHIMS-ECHO Study Groups. Long-term Effects on Cognitive Trajectories of Postmenopausal Hormone Therapy in Two Age Groups. J Gerontol A Biol Sci Med Sci. 2017 Jun 1;72(6):838-845. doi: 10.1093/gerona/glw156.
citation: Gaussoin SA, Espeland MA, Beavers DP, Casanova R, Garcia KR, Snively BM, Shumaker SA, Wallace RB, Rapp SR. Dementia outcomes after addition of proxy-based assessments for deceased or proxy-dependent participants. Int J Geriatr Psychiatry. 2019 Oct;34(10):1403-1411. doi: 10.1002/gps.5130. Epub 2019 May 23.