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Neurology. 2015 Dec 1;85(22):1937-44. doi: 10.1212/WNL.0000000000002171. Epub 2015 Nov 4.

Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial.

Author information

1
From the Departments of Health Research and Policy (Epidemiology) (V.W.H., K.L.S.), Neurology and Neurological Sciences (V.W.H.), and Psychiatry and Behavioral Sciences (A.C.R.), Stanford University, CA; Department of Neurology (T.A.), Southern Illinois University School of Medicine, Springfield; Neurology (A.L.B.) and Family Medicine (B.S.S.) Departments, Kaiser Permanente Santa Rosa Medical Center, CA; Palo Alto Veterans Affairs Health Care System (A.C.R.), CA; and Department of Neurology (M.R.F.), Indiana University School of Medicine, Indianapolis. A.L.B. is currently affiliated with Sonoma West Medical Center, Sebastopol, CA. vhenderson@stanford.edu.
2
From the Departments of Health Research and Policy (Epidemiology) (V.W.H., K.L.S.), Neurology and Neurological Sciences (V.W.H.), and Psychiatry and Behavioral Sciences (A.C.R.), Stanford University, CA; Department of Neurology (T.A.), Southern Illinois University School of Medicine, Springfield; Neurology (A.L.B.) and Family Medicine (B.S.S.) Departments, Kaiser Permanente Santa Rosa Medical Center, CA; Palo Alto Veterans Affairs Health Care System (A.C.R.), CA; and Department of Neurology (M.R.F.), Indiana University School of Medicine, Indianapolis. A.L.B. is currently affiliated with Sonoma West Medical Center, Sebastopol, CA.

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.

PMID:
26537053
PMCID:
PMC4664126
DOI:
10.1212/WNL.0000000000002171
[Indexed for MEDLINE]
Free PMC Article

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