Raloxifene for women with Alzheimer disease

Victor W. Henderson, Tom Ala, Kristin L. Sainani, Allan L. Bernstein, B. Sue Stephenson, Allyson C. Rosen, Martin Farlow

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Objective: To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect. Methods: This pilot study was conducted as a randomized, double-blind, placebo-controlled trial, with a planned treatment of 12 months. Women with late-onset AD of mild to moderate severity were randomly allocated to high-dose (120 mg) oral raloxifene or identical placebo provided once daily. The primary outcome compared between treatment groups at 12 months was change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog). Results: Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68-84), and 39 women contributed 12-month outcomes. ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval -0.39 to 0.44, 2-tailed p 0.89). Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score. Caregiver burden and caregiver distress were similar in both groups. Conclusions: Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group. Classification of evidence: This study provides Class I evidence that for women with AD, raloxifene does not have a significant cognitive effect. The study lacked the precision to exclude a small effect.

Original languageEnglish (US)
Pages (from-to)1937-1944
Number of pages8
JournalNeurology
Volume85
Issue number22
DOIs
StatePublished - Dec 1 2015

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Alzheimer Disease
Placebos
Cognition
Caregivers
Selective Estrogen Receptor Modulators
Activities of Daily Living
Dementia
Raloxifene Hydrochloride
Therapeutics
Confidence Intervals

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Henderson, V. W., Ala, T., Sainani, K. L., Bernstein, A. L., Stephenson, B. S., Rosen, A. C., & Farlow, M. (2015). Raloxifene for women with Alzheimer disease. Neurology, 85(22), 1937-1944. https://doi.org/10.1212/WNL.0000000000002171

Raloxifene for women with Alzheimer disease. / Henderson, Victor W.; Ala, Tom; Sainani, Kristin L.; Bernstein, Allan L.; Stephenson, B. Sue; Rosen, Allyson C.; Farlow, Martin.

In: Neurology, Vol. 85, No. 22, 01.12.2015, p. 1937-1944.

Research output: Contribution to journalArticle

Henderson, VW, Ala, T, Sainani, KL, Bernstein, AL, Stephenson, BS, Rosen, AC & Farlow, M 2015, 'Raloxifene for women with Alzheimer disease', Neurology, vol. 85, no. 22, pp. 1937-1944. https://doi.org/10.1212/WNL.0000000000002171
Henderson VW, Ala T, Sainani KL, Bernstein AL, Stephenson BS, Rosen AC et al. Raloxifene for women with Alzheimer disease. Neurology. 2015 Dec 1;85(22):1937-1944. https://doi.org/10.1212/WNL.0000000000002171
Henderson, Victor W. ; Ala, Tom ; Sainani, Kristin L. ; Bernstein, Allan L. ; Stephenson, B. Sue ; Rosen, Allyson C. ; Farlow, Martin. / Raloxifene for women with Alzheimer disease. In: Neurology. 2015 ; Vol. 85, No. 22. pp. 1937-1944.
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