Evidence map›Paper›PMID 27048170›Full record

Trial reportAlzheimer's research & therapy2016

Safety and tolerability of BAN2401--a clinical study in Alzheimer's disease with a protofibril selective Aβ antibody.

Veronika Logovinsky, Andrew Satlin, Robert Lai, Chad Swanson, June Kaplow, Gunilla Osswald, Hans Basun, Lars Lannfelt

Registry-linked trialOpen access · goldAbstract readMulticenter 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 trial NCT01230853 (A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of BAN2401 in Subjects With Mild to Moderate Alzheimer?s Disease), which is not on this map. Cited by 148 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 8 pooled it
9.0field-weighted citation impact, top 2% 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.

NCT01230853 phase1completednot on this map

A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of BAN2401 in Subjects With Mild to Moderate Alzheimer?s Disease

TypeinterventionalSponsorEisai Inc.Ran2010 to 2013Enrolled80ConditionsAlzheimer's DiseaseArmsActive Comparator: A, Placebo Comparator B, Active Comparator B, Placebo Comparator A
3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 8 syntheses or guidelines pooled it, 280 citations in OpenAlex.

  1. Pooled it
  2. The efficacy and safety of lecanemab 10 mg/kg biweekly compared to a placebo in patients with Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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88 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

8 authors at 3 institutions in 2 countries.

Veronika LogovinskyEisai, Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA.
Andrew SatlinEisai, Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA.
Robert LaiEisai, Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA.
Chad SwansonEisai, Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA.
June KaplowEisai, Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA.
Gunilla OsswaldBioArctic Neuroscience AB, Warfvinges väg 35, 112 51, Stockholm, Sweden.
Hans BasunBioArctic Neuroscience AB, Warfvinges väg 35, 112 51, Stockholm, Sweden.
Lars LannfeltBioArctic Neuroscience AB, Warfvinges väg 35, 112 51, Stockholm, Sweden. Lars.Lannfelt@pubcare.uu.se.
Eisai (United States) · USUppsala University · SEBioArctic Neuroscience (Sweden) · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral monoclonal antibodies for the treatment of Alzheimer's disease (AD) have been in development over the last decade. BAN2401 is a monoclonal antibody that selectively binds soluble amyloid β (Aβ) protofibrils.

methodsHere we describe the first clinical study with BAN2401. Safety and tolerability were investigated in mild to moderate AD. A study design was used with staggered parallel single and multiple ascending doses, from 0.1 mg/kg as a single dose to 10 mg/kg biweekly for four months. The presence of amyloid related imaging abnormalities (ARIA, E for edema, H for hemorrhage) was assessed with magnetic resonance imaging (MRI). Cerebrospinal fluid (CSF) and plasma samples were analyzed to investigate pharmacokinetics (PK) and effects on biomarkers.

resultsThe incidence of ARIA-E/H on MRI was comparable to that of placebo. BAN2401 exposure was approximately dose proportional, with a serum terminal elimination half-life of ~7 days. Only a slight increase of plasma Aβ(1-40) was observed but there were no measurable effects of BAN2401 on CSF biomarkers. On the basis of these findings Phase 2b efficacy study has been initiated in early AD.

conclusionsBAN2401 was well-tolerated across all doses. The PK profile has guided us for selecting dose and dose regimens in the ongoing phase 2b study. There was no clear guidance for an effective dose based on biomarkers. TRIAL REGISTRATION NUMBER: NCT01230853 ClinicalTrials.gov Registered October 27, 2010.

Indexed as

AgedAlzheimer DiseaseAmyloid beta-PeptidesAntibodies, Monoclonal, HumanizedBiomarkersBrainDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMalePeptide FragmentsAmyloid beta-Peptidesamyloid beta-protein (1-41)Antibodies, Monoclonal, HumanizedBiomarkerslecanemabPeptide FragmentsAlzheimer's diseaseAmyloid-βARIAAβBAN2401Clinical trialImmunotherapymAb158Protofibril

Identifiers

PMID27048170
PMCPMC4822297
OpenAlexW2330649365

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.