The question whether or not postmenopausal hormone therapy (HT) has any effect on cognition and Alzheimer’s disease is quite intriguing. I guess that most of us are not aware of an ongoing study called WHIMS-Y, as detailed in the abstract below from [i]Brain Research[/i] [1].
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The Women’s Health Initiative Memory Study-Younger (WHIMS-Y) was designed to assess the effect of prior random assignment to HT (conjugated equine estrogen (CEE) alone or CEE plus medroxyprogesterone acetate (MPA)) on global cognitive function in younger middle-aged women relative to placebo. WHIMS-Y was an ancillary study to the Women’s Health Initiative (WHI) HT trial and enrolled 1361 women who were aged 50–54 years and postmenopausal at WHI enrollment. WHIMS-Y will examine whether an average of 5.4 years of HT during early menopause has longer-term protective effects on global cognitive function and if these effects vary by regimen, time between menopause and study initiation, and prior use of HT. We present the study rationale and design. We describe enrollment, adherence to assigned WHI therapy, and compare risk factor characteristics of the WHIMS-Y cohort at the time of WHI enrollment to similarly aged women in the WHI HT who did not enroll in WHIMS-Y. Challenges of WHIMS-Y include lower than expected and differential enrollment. Strengths of WHIMS-Y include balance in baseline risk factors between treatment groups, standardized and masked data collection, and high rates of retention and on-trial adherence and exposure. In addition, the telephone-administered cognitive battery showed adequate construct validity. WHIMS-Y provided an unprecedented chance to examine the hypothesis that HT may have protective effects on cognition in younger postmenopausal women aged 50–54 years. Integrated into the WHI, WHIMS-Y optimized the experience of WHI investigators to ensure high retention and excellent quality assurance across sites.
Author(s)
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Amos Pines
Department of Medicine T, Ichilov Hospital, Tel-Aviv, Israel
Citations
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Vaughan L, Espeland MA, Snively B, et al. The rationale, design, and baseline characteristics of the Womens Health Initiative Memory Study of Younger Women (WHIMS-Y). Brain Res 2013 Apr 8. Epub ahead of print
http://www.ncbi.nlm.nih.gov/pubmed/23578696 -
Rapp SR, Espeland MA, Shumaker SA, et al. Effect of estrogen plus progestin on global cognitive function in postmenopausal women: the Womens Health Initiative Memory Study: a randomized controlled trial. JAMA 2003;289:2663-72.
http://www.ncbi.nlm.nih.gov/pubmed/12771113 -
Shumaker SA, Legault C, Rapp SR, et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Womens Health Initiative Memory Study: a randomized controlled trial. JAMA 2003;289:2651-62.
http://www.ncbi.nlm.nih.gov/pubmed/12771112 -
Espeland MA, Rapp SR, Shumaker SA, et al. Conjugated equine estrogens and global cognitive function in postmenopausal women: Womens Health Initiative Memory Study. JAMA 2004;291:2959-68.
http://www.ncbi.nlm.nih.gov/pubmed/15213207 -
Shumaker SA, Legault C, Kuller L, et al. Conjugated equine estrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Womens Health Initiative Memory Study. JAMA 2004;291:2947-58.
http://www.ncbi.nlm.nih.gov/pubmed/15213206 -
Espeland MA, Brunner RL, Hogan PE, et al. Long-term effects of conjugated equine estrogen therapies on domain-specific cognitive function: results from the Womens Health Initiative study of cognitive aging extension. J Am Geriatr Soc 2010;58:1263-71.
http://www.ncbi.nlm.nih.gov/pubmed/20649689 -
Espeland MA, Brunner RL, Hogan PE, et al. Long-term effects of conjugated equine estrogen therapies on domain-specific cognitive function: results from the Womens Health Initiative study of cognitive aging extension. J Am Geriatr Soc 2010;58:1263-71.
http://www.ncbi.nlm.nih.gov/pubmed/22612612 -
Manson JE, Allison MA, Rossouw JE, et al. Estrogen therapy and coronary-artery calcification. N Engl J Med 2007;356:2591-602.
http://www.ncbi.nlm.nih.gov/pubmed/17582069
