Evidence map›Paper›PMID 26537053›Full record

Trial reportNeurology2015

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

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

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Evaluating the Use of Anxiety Patient-Reported Outcome Measures (PROMs) in Dementia Clinical Trials: A Systematic Review.Health expectations : an international journal of public participation in health care and health policy · 2026
    Pooled it
  2. Pooled it
  3. Semantic Memory in the Clinical Progression of Alzheimer Disease.Cognitive and behavioral neurology : official journal of the Society for Behavioral and Cognitive Neurology · 2017
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Victor W HendersonFrom 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.
Tom AlaFrom 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.
Kristin L SainaniFrom 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.
Allan L BernsteinFrom 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.
B Sue StephensonFrom 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.
Allyson C RosenFrom 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.
Martin R FarlowFrom 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.
Kaiser Permanente Santa Rosa Medical Center · USSouthern Illinois University School of Medicine · US

Funding

TRIAL OF VALPROATE TO ATTENUATE THE PROGRESSION OF ADU01AG010483 · NIA · UNIVERSITY OF ROCHESTER · PI AISEN, PAUL S. · 1991 to 2012
$116.2M
RECRUITMENT COREU19AG010483 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FELDMAN, HOWARD · 2013 to 2020
$80.6M
Raloxifene in Women with AD: Randomized Controlled TrialR01AG023038 · NIA · STANFORD UNIVERSITY · PI HENDERSON, VICTOR · 2005 to 2007
$1.1M
NIA NIH HHS AG10483NIA NIH HHS R01-AG023038NIA NIH HHS U01 AG010483
6 · The paper itself

Abstract

objectiveTo 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.

methodsThis 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).

resultsForty-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.

conclusionsResults 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.

Indexed as

Activities of Daily LivingAgedAged, 80 and overAlzheimer DiseaseCholinesterase InhibitorsCognitionDouble-Blind MethodFemaleHumansPilot ProjectsRaloxifene HydrochlorideTreatment OutcomeCholinesterase InhibitorsRaloxifene Hydrochloride

Identifiers

PMID26537053
PMCPMC4664126
OpenAlexW2099405031

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.