Evidence map›Paper›PMID 29124109›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2017

The effect of diagnostic criteria on outcome measures in preclinical and prodromal Alzheimer's disease: Implications for trial design.

Daniela Bertens, Betty M Tijms, Lisa Vermunt, Niels D Prins, Philip Scheltens, Pieter Jelle Visser

Registry-linked trialAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05153941 (DNS Cohort Study Aimed at Understanding the Pathophysiology of AD and AD Related Disorders), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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.

NCT05153941 active not recruitingnot on this mapstarted 2022, after this paper: background citation

DNS Cohort Study Aimed at Understanding the Pathophysiology of AD and AD Related Disorders (ADRD)

TypeobservationalSponsorAltoidaRan2022 to 2030Enrolled3,500ConditionsAlzheimer's Disease, Mild Cognitive Impairment
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

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  15. Predicting long-term clinical stability in amyloid-positive subjects by FDG-PET.Annals of clinical and translational neurology · 2019
    Article
  16. Pre-amyloid stage of Alzheimer's disease in cognitively normal individuals.Annals of clinical and translational neurology · 2018
    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

6 authors.

Daniela BertensAlzheimer Centre, Department of Neurology, VU University Medical Centre, Amsterdam, The Netherlands.
Betty M TijmsAlzheimer Centre, Department of Neurology, VU University Medical Centre, Amsterdam, The Netherlands.
Lisa VermuntAlzheimer Centre, Department of Neurology, VU University Medical Centre, Amsterdam, The Netherlands.
Niels D PrinsAlzheimer Centre, Department of Neurology, VU University Medical Centre, Amsterdam, The Netherlands.
Philip ScheltensAlzheimer Centre, Department of Neurology, VU University Medical Centre, Amsterdam, The Netherlands.
Pieter Jelle VisserAlzheimer Centre, Department of Neurology, VU University Medical Centre, Amsterdam, The Netherlands.

Funding

Alzheimer's Disease Neuroimaging Initiative - SupplementU01AG024904 · NIA · NORTHERN CALIFORNIA INSTITUTE RES &EDUC · PI WEINER, MICHAEL W · 2004 to 2015
$121.0M
NIA NIH HHS U01 AG024904
6 · The paper itself

Abstract

introductionWe investigated the influence of different inclusion criteria for preclinical and prodromal Alzheimer's disease (AD) on changes in biomarkers and cognitive markers and on trial sample size estimates.

methodsWe selected 522 cognitively normal subjects and 872 subjects with mild cognitive impairment from the Alzheimer's Disease Neuroimaging Initiative study. Compared inclusion criteria were (1) preclinical or prodromal AD (amyloid marker abnormal); (2) preclinical or prodromal AD stage-1 (amyloid marker abnormal, injury marker normal); and (3) preclinical or prodromal AD stage-2 (amyloid and injury markers abnormal). Outcome measures were amyloid, neuronal injury, and cognitive markers.

resultsIn both subjects with preclinical and prodromal AD stage-2, inclusion criteria resulted in the largest observed decline in brain volumetric measures on magnetic resonance imaging and cognitive markers. DISCUSSION: Inclusion criteria influence the observed rate of worsening in outcome measures. This has implications for trial design.

Indexed as

Alzheimer's diseaseBiomarkersClinical trialCognitive markersLongitudinalPreclinicalProdromalSample size estimates

Identifiers

PMID29124109
PMCPMC5671625

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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.