Evidence map›Paper›PMID 29854935›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2015

Alzheimer's disease assessment scale-cognitive 11-item progression model in mild-to-moderate Alzheimer's disease trials of bapineuzumab.

Mahesh N Samtani, Steven X Xu, Alberto Russu, Omoniyi J Adedokun, Ming Lu, Kaori Ito, Brian Corrigan, Sangeeta Raje, H Robert Brashear, Scot Styren and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2015. 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 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 23% 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.

NCT00574132 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non- Carriers.

TypeinterventionalSponsorJANSSEN Alzheimer Immunotherapy Research & Development, LLCRan2007 to 2012Enrolled1,331ConditionsAlzheimer's DiseaseArmsBapineuzumab 0.5 mg/kg, Placebo Control, Bapineuzumab 1.0 m/kg
NCT00575055 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.

TypeinterventionalSponsorJANSSEN Alzheimer Immunotherapy Research & Development, LLCRan2007 to 2012Enrolled1,121ConditionsAlzheimer's DiseaseArmsBapineuzumab 0.5 mg/kg, Placebo Control, Bapineuzumab 1.0 m/kg
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  10. Longitudinal Sensitivity of Alzheimer's Disease Severity Staging.American journal of Alzheimer's disease and other dementias
    Article
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

11 authors at 2 institutions in 1 country.

Mahesh N SamtaniJanssen Research & Development, LLC, NJ, USA.
Steven X XuJanssen Research & Development, LLC, NJ, USA.
Alberto RussuJanssen Research & Development, LLC, NJ, USA.
Omoniyi J AdedokunJanssen Research & Development, LLC, NJ, USA.
Ming LuJanssen Research & Development, LLC, NJ, USA.
Kaori ItoPfizer Ltd., CT, USA.
Brian CorriganPfizer Ltd., CT, USA.
Sangeeta RajePfizer Ltd., CT, USA.
H Robert BrashearJanssen Research & Development, LLC, NJ, USA.
Scot StyrenPfizer Ltd., CT, USA.
Chuanpu HuJanssen Research & Development, LLC, NJ, USA.
Janssen (United States) · USPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe objective of this study was to estimate longitudinal changes in disease progression (measured by Alzheimer's disease assessment scale-cognitive 11-item [ADAS-cog/11] scale) after bapineuzumab treatment and to identify covariates (demographics or baseline characteristics) contributing to the variability in disease progression rate and baseline disease status.

methodsA population-based disease progression model was developed using pooled placebo and bapineuzumab data from two phase-3 studies in

resultsA beta regression model with the Richard's function as the structural component best described ADAS-cog/11 disease progression for mild-to-moderate AD population. This analysis confirmed no effect of bapineuzumab exposure on ADAS-cog/11 progression rate, consistent with the lack of clinical efficacy observed in the statistical analysis of ADAS-cog/11 data in both studies. Assessment of covariates affecting baseline severity revealed that men had a 6% lower baseline ADAS-cog/11 score than women; patients who took two AD concomitant medications had a 19% higher (worse) baseline score; DISCUSSION: The beta regression model is a sensible modeling approach to characterize cognitive decline in AD patients. The influence of bapineuzumab exposure on disease progression measured by ADAS-cog/11 was not significant.

trial registrationClinicalTrials.gov identifier: NCT00575055 and NCT00574132.

Indexed as

ADAS-cog/11Alzheimer's diseaseBapineuzumabDisease progression model

Identifiers

PMID29854935
PMCPMC5975060
OpenAlexW2200279857

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.