Evidence map›Paper›PMID 31193334›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2019

Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease.

Clive Ballard, Alireza Atri, Neli Boneva, Jeffrey L Cummings, Lutz Frölich, José Luis Molinuevo, Pierre N Tariot, Lars Lau Raket

4 registry-linked trialsAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 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.

NCT01955161 phase3completednot on this map

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

TypeinterventionalSponsorH. Lundbeck A/SRan2013 to 2016Enrolled933ConditionsAlzheimer's DiseaseArmsPlacebo, Idalopirdine
NCT02006641 phase3completednot on this map

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

TypeinterventionalSponsorH. Lundbeck A/SRan2014 to 2016Enrolled858ConditionsAlzheimer's DiseaseArmsPlacebo, Idalopirdine
NCT02006654 phase3completednot on this map

Randomised, Double-blind, Parallel-group, Placebo-controlled Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

TypeinterventionalSponsorH. Lundbeck A/SRan2014 to 2017Enrolled734ConditionsAlzheimer's DiseaseArmsPlacebo, Idalopirdine
NCT06362707 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Placebo Controlled Randomized Double-blind Parallel Group 12-month Trial of Fasudil for the Treatment of Early Alzheimer's Disease (FEAD)

TypeinterventionalSponsorHelse Stavanger HFRan2024 to 2028Enrolled200ConditionsCognitive Decline, Mild, Alzheimer DiseaseArmsFasudil, Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Polygenic score integrating neurodegenerative and vascular risk informs dementia risk stratification.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
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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

8 authors.

Clive BallardUniversity of Exeter Medical School, Exeter, UK.
Alireza AtriBanner Sun Health Research Institute, Sun City, AZ, USA.
Neli BonevaH. Lundbeck A/S, Valby, Denmark.
Jeffrey L CummingsCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Lutz FrölichCentral Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Heidelberg, Germany.
José Luis MolinuevoAlzheimer's Disease and Other Cognitive Disorders Unit, IDIBAPS, Hospital Clinic i Universitari, Barcelona, Spain.
Pierre N TariotBanner Alzheimer's Institute, Phoenix, AZ, USA.
Lars Lau RaketH. Lundbeck A/S, Valby, Denmark.

Funding

Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI JESSICA KIRKLAND CALDWELL · 2015 to 2026
$22.8M
NIGMS NIH HHS P20 GM109025
6 · The paper itself

Abstract

introductionHeterogeneity of outcomes in Alzheimer's disease (AD) clinical trials necessitates large sample sizes and contributes to study failures. This analysis determined whether mild-to-moderate AD populations could be enriched for cognitive decline based on apolipoprotein (

methodsModeling estimated the number of randomized patients needed to detect a 2-point treatment difference on the AD Assessment Scale-Cognitive subscale using placebo data from three randomized, double-blind trials (ClinicalTrials.gov Identifiers: NCT01955161, NCT02006641, and NCT02006654).

resultsAn 80% power to detect a 2-point treatment effect required the randomization of 148 amyloid-positive patients; 178 ε4 homozygous or amyloid-positive patients; and 231 ε4 homozygous, family history-positive, or amyloid-positive patients, compared with 1619 unenriched patients (per arm). DISCUSSION: Enrichment in mild-to-moderate AD clinical trials can be achieved using combinations of biomarkers/risk factors to increase the likelihood of observing potential treatment effects.

Indexed as

Alzheimer's diseaseBiomarkersClinical trialEnrichmentPower

Identifiers

PMID31193334
PMCPMC6527908

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.