Evidence map›Paper›PMID 27176461›Full record

Trial reportAlzheimer's research & therapy2016

Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials.

Rik Vandenberghe, Juha O Rinne, Mercè Boada, Sadao Katayama, Philip Scheltens, Bruno Vellas, Michael Tuchman, Achim Gass, Jochen B Fiebach, Derek Hill and 13 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 154 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
154citing papers in PubMed, 13 pooled it
17.9field-weighted citation impact, top 1% 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.

NCT00667810 phase3terminatednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers

TypeinterventionalSponsorPfizerRan2008 to 2013Enrolled901ConditionsAlzheimer DiseaseArmsbapineuzumab, placebo
NCT00676143 phase3terminatednot on this map

A Phase Iii, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy And Safety Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Carriers

TypeinterventionalSponsorPfizerRan2008 to 2012Enrolled1,100ConditionsAlzheimer DiseaseArmsbapineuzumab, placebo
3 · Its place in the literature

Who cites it

154 citing papers in PubMed, 13 syntheses or guidelines pooled it, 293 citations in OpenAlex.

  1. Incidence, severity, and associated risk factors for amyloid-related imaging abnormalities in anti-amyloid monoclonal antibody therapy for early Alzheimer's disease: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
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  7. Efficacy of anti-amyloid-ß monoclonal antibody therapy in early Alzheimer's disease: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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  14. Trial
  15. Association of CSF AβNeurology · 2022
    Trial
  16. Quantitative amyloid PET in Alzheimer's disease: the AMYPAD prognostic and natural history study.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2020
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94 more citing papers are in PubMed but not listed here.

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

23 authors at 13 institutions in 9 countries.

Rik VandenbergheUniversity Hospitals Leuven, Department of Neurosciences, Alzheimer Research Centre KU Leuven, Herestraat 49, 3000, Leuven, Belgium. rik.vandenberghe@uzleuven.be.
Juha O RinneTurku PET Centre and Division of Clinical Neurosciences, University of Turku and Turku University Hospital, Kiinamyllynkatu 4-8, 20520, Turku, Finland.
Mercè BoadaFundació ACE, Barcelona Alzheimer Treatment and Research Center, Gran via de Carles III, 85 Bis, 08028, Barcelona, Spain.
Sadao KatayamaGraduate School of Biomedical Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
Philip ScheltensAlzheimercentrum VUmc, Neurology, VU University Medical Center, PO Box 7057, 1007, MB, Amsterdam, Netherlands.
Bruno VellasCHU Toulouse, Gérontopôle, 170 Avenue de Casselardit, TSA 40031, 31059, Toulouse, Cedex 9, France.
Michael TuchmanPalm Beach Neurological Center, 3365 Burns Road, Suite 203, Palm Beach Gardens, FL, 33410, USA.
Achim GassDepartment of Neurology, University Hospital Mannheim, University Medical Centre Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Jochen B FiebachCenter for Stroke Research Berlin (CSB), Charité Universitätsmedizin Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
Derek HillIXICO Ltd., The London Bioscience Innovation Centre, 4th Floor, Griffin Court, 15 Long Lane, London, EC1A 9PN, UK.
Kasia LobelloPfizer Inc., 500 Arcola Road, Collegeville, PA, 19426, USA.
David LiPfizer Inc., 500 Arcola Road, Collegeville, PA, 19426, USA.
Tom McRaePfizer Inc., 235 East 42nd Street, New York, NY, 10017, USA.
Prisca LucasPfizer Global Research and Development (PGRD), 23-25 avenue Du Docteur Lannelongue, Paris, Île-De-France, 75014, France.
Iona EvansPfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK.
Kevin BoothPfizer Inc., 500 Arcola Road, Collegeville, PA, 19426, USA.
Gerald LuscanPfizer Global Research and Development (PGRD), 23-25 avenue Du Docteur Lannelongue, Paris, Île-De-France, 75014, France.
Bradley T WymanPfizer Inc., 7 Kings Highway, Groton, CT, 06340, USA.
Lisa HuaPfizer Inc., 500 Arcola Road, Collegeville, PA, 19426, USA.
Lingfeng YangPfizer Inc., 500 Arcola Road, Collegeville, PA, 19426, USA.
H Robert BrashearJanssen Alzheimer Immunotherapy Research & Development, LLC, 700 Gateway Boulevard, South San Francisco, CA, 94080, USA.
Ronald S BlackPfizer Inc., 500 Arcola Road, Collegeville, PA, 19426, USA.
Bapineuzumab 3000 and 3001 Clinical Study Investigators
Pfizer (United States) · USPfizer (France) · FRAmsterdam UMC Location VUmc · NLCharité - Universitätsmedizin Berlin · DEFundació ACE · ESHeidelberg University · DEHiroshima University · JPJanssen (United States) · USKU Leuven · BEMédipole Garonne · FRPalm Beach Neurological Center · USPfizer (United Kingdom) · GBTurku PET Centre · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOur objective was to evaluate the efficacy (clinical and biomarker) and safety of intravenous bapineuzumab in patients with mild to moderate Alzheimer's disease (AD).

methodsTwo of four phase 3, multicenter, randomized, double-blind, placebo-controlled, 18-month trials were conducted globally: one in apolipoprotein E ε4 carriers and another in noncarriers. Patients received bapineuzumab 0.5 mg/kg (both trials) or 1.0 mg/kg (noncarrier trial) or placebo every 13 weeks. Coprimary endpoints were change from baseline to week 78 on the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscale and the Disability Assessment for Dementia.

resultsA total of 683 and 329 patients completed the current carrier and noncarrier trials, respectively, which were terminated prematurely owing to lack of efficacy in the two other phase 3 trials of bapineuzumab in AD. The current trials showed no significant difference between bapineuzumab and placebo for the coprimary endpoints and no effect of bapineuzumab on amyloid load or cerebrospinal fluid phosphorylated tau. (Both measures were stable over time in the placebo group.) Amyloid-related imaging abnormalities with edema or effusion were confirmed as the most notable adverse event.

conclusionsThese phase 3 global trials confirmed lack of efficacy of bapineuzumab at tested doses on clinical endpoints in patients with mild to moderate AD. Some differences in the biomarker results were seen compared with the other phase 3 bapineuzumab trials. No unexpected adverse events were observed.

trial registrationNoncarriers (3000) ClinicalTrials.gov identifier NCT00667810 ; registered 24 Apr 2008. Carriers (3001) ClinicalTrials.gov identifier NCT00676143 ; registered 2 May 2008.

Indexed as

AgedAlzheimer DiseaseAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedApolipoprotein E4BiomarkersBrainFemaleHumansMaleNeuropsychological TestsPositron-Emission TomographySeverity of Illness Indextau ProteinsTreatment OutcomeAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedApolipoprotein E4bapineuzumabBiomarkersMAPT protein, humantau ProteinsAlzheimer’s diseaseAmyloid βARIA-EBapineuzumabClinical trialImmunotherapyVasogenic edema

Identifiers

PMID27176461
PMCPMC4866415
OpenAlexW2385703614

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.