Evidence map›Paper›PMID 20009055›Full record

Trial reportJAMA2009

Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial.

Robert C Green, Lon S Schneider, David A Amato, Andrew P Beelen, Gordon Wilcock, Edward A Swabb, Kenton H Zavitz, Tarenflurbil Phase 3 Study Group

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA, 2009. 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 288 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
288citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT00105547 phase3completednot on this map

Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment With MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects With Mild Dementia of the Alzheimer's Type

TypeinterventionalSponsorMyrexis Inc.Ran2005 to 2008Enrolled1,600ConditionsAlzheimer Disease, DementiaArmsMPC-7869
NCT03277573 phase1completednot on this mapstarted 2017, after this paper: background citation

A Phase 1b, 12-Month, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Salsalate in Patients With Mild to Moderate Alzheimer's Disease

TypeinterventionalSponsorAdam BoxerRan2017 to 2023Enrolled40ConditionsAlzheimer DiseaseArmsSalsalate, Placebo
3 · Its place in the literature

Who cites it

288 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  8. Vitamin E and memantine in Alzheimer's disease: clinical trial methods and baseline data.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2014
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  9. Results of a follow-up study to the randomized Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT).Alzheimer's & dementia : the journal of the Alzheimer's Association · 2013
    Trial
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228 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Robert C GreenDepartment of Neurology, Boston University School of Medicine, 72 E Concord St, L-320, Boston, MA 02118, USA. rcgreen@bu.edu
Lon S Schneider
David A Amato
Andrew P Beelen
Gordon Wilcock
Edward A Swabb
Kenton H Zavitz
Tarenflurbil Phase 3 Study Group

Funding

VASCULAR RISK AND COGNITIVE STATUS IN A LATINO POPULATIONP50AG005142 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ARANDA, MARIA P. · 1985 to 2019
$41.0M
PSYCHOSOCIAL COREP30AG008051 · NIA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI SHAO, YONGZHAO · 1990 to 2019
$36.1M
Neuropathology CoreP30AG013846 · NIA · BOSTON UNIVERSITY MEDICAL CAMPUS · PI KOWALL, NEIL W. · 1996 to 2020
$29.1M
YOGA INDUCED CHANGES IN BRAIN GABA LEVELSM01RR000533 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI HOLICK, MICHAEL F. · 1985 to 2008
$19.4M
Risk Evaluation and Education for Alzheimer's Disease (REVEAL IV)R01HG002213 · NHGRI · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C. · 1999 to 2012
$7.6M
Characterizing Communicating Genetic Risk Alzheimer'sK24AG027841 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C. · 2006 to 2010
$914k
Department of HealthNCRR NIH HHS M01 RR000533NCRR NIH HHS M01-RR00533NHGRI NIH HHS R01 HG002213NHGRI NIH HHS R01-HG02213NIA NIH HHS K24 AG027841NIA NIH HHS K24-AG027841NIA NIH HHS P30 AG008051NIA NIH HHS P30 AG013846NIA NIH HHS P30-AG13846NIA NIH HHS P50 AG005142
6 · The paper itself

Abstract

contextAmyloid-beta peptide (Abeta(42)) has been implicated in the pathogenesis of Alzheimer disease (AD). Tarenflurbil, a selective Abeta(42)-lowering agent, demonstrated encouraging results on cognitive and functional outcomes among mildly affected patients in an earlier phase 2 trial.

objectiveTo determine the efficacy, safety, and tolerability of tarenflurbil. DESIGN, SETTING, AND PATIENTS: A multicenter, randomized, double-blind, placebo-controlled trial enrolling patients with mild AD was conducted at 133 trial sites in the United States between February 21, 2005, and April 30, 2008. Concomitant treatment with cholinesterase inhibitors or memantine was permitted.

interventionTarenflurbil, 800 mg, or placebo, administered twice a day.

main outcome measuresCo-primary efficacy end points were the change from baseline to month 18 in total score on the subscale of the Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog, 80-point version) and Alzheimer Disease Cooperative Studies-activities of daily living (ADCS-ADL) scale. Additional prespecified slope analyses explored the possibility of disease modification.

resultsOf the 1684 participants randomized, 1649 were included in the analysis, and 1046 completed the trial. Tarenflurbil had no beneficial effect on the co-primary outcomes (difference in change from baseline to month 18 vs placebo, based on least squares means: 0.1 for ADAS-Cog; 95% CI, -0.9 to 1.1; P = .86 and -0.5 for ADCS-ADL; 95% CI, -1.9 to 0.9; P = .48) using an intent-to-treat analysis. No significant differences occurred in the secondary outcomes. The ADAS-Cog score decreased by 7.1 points over 18 months. The tarenflurbil group had a small increase in frequency of dizziness, anemia, and infections.

conclusionTarenflurbil did not slow cognitive decline or the loss of activities of daily living in patients with mild AD.

trial registrationclinicaltrials.gov Identifier: NCT00105547.

Indexed as

Activities of Daily LivingAgedAged, 80 and overAlzheimer DiseaseAmyloid beta-PeptidesAmyloid Precursor Protein SecretasesCognitionCognition DisordersDouble-Blind MethodEnzyme InhibitorsFemaleFlurbiprofenHumansMaleMiddle AgedPeptide FragmentsAmyloid beta-PeptidesAmyloid Precursor Protein SecretasesEnzyme InhibitorsFlurbiprofenPeptide Fragmentstarenflurbil

Identifiers

PMID20009055
PMCPMC2902875

What OpenQuestion holds

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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.