Evidence map›Paper›PMID 28345017›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2016

Proof of concept demonstration of optimal composite MRI endpoints for clinical trials.

Steven D Edland, M Colin Ard, Jaiashre Sridhar, Derin Cobia, Adam Martersteck, M Marsel Mesulam, Emily J Rogalski

Registry-linked trialAbstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04946149 (Psychosocial Factors, Lifestyle and Central Pain Processing as Potential Predictors of Outcome After Rehabilitation for Rotator Cuff Repair), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

NCT04946149 completednot on this mapstarted 2019, after this paper: background citation

Psychosocial Factors, Lifestyle and Central Pain Processing as Potential Predictors of Outcome After Rehabilitation for Rotator Cuff Repair: A Study Design for a Prospective Longitudinal Cohort Study

TypeobservationalSponsorKantonsspital Winterthur KSWRan2019 to 2022Enrolled142ConditionsRotator Cuff Tear or Rupture, Not Specified as Traumatic
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Observational
  5. Clinical and cortical decline in the aphasic variant of Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2019
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. 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

7 authors.

Steven D EdlandDivision of Biostatistics, Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, USA; Department of Neurosciences, University of California San Diego, La Jolla, CA, USA.
M Colin ArdDepartment of Neurosciences, University of California San Diego, La Jolla, CA, USA.
Jaiashre SridharNorthwestern University Feinberg School of Medicine, Cognitive Neurology and Alzheimer's Disease Center, Chicago, IL, USA.
Derin CobiaNorthwestern University Feinberg School of Medicine, Department of Psychiatry and Behavioral Sciences, Chicago, IL, USA.
Adam MartersteckNorthwestern University Feinberg School of Medicine, Cognitive Neurology and Alzheimer's Disease Center, Chicago, IL, USA; Northwestern University Feinberg School of Medicine, Department of Radiology, Chicago, IL, USA.
M Marsel MesulamNorthwestern University Feinberg School of Medicine, Cognitive Neurology and Alzheimer's Disease Center, Chicago, IL, USA; Northwestern University Feinberg School of Medicine, Department of Neurology, Chicago, IL, USA.
Emily J RogalskiNorthwestern University Feinberg School of Medicine, Cognitive Neurology and Alzheimer's Disease Center, Chicago, IL, USA.

Funding

UC San Diego Clinical and Translational Research InstituteUL1TR001442 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S, HOGARTH, MICHAEL · 2015 to 2024
$88.3M
VIRUS-INDUCED BRAIN PATHOLOGYP50AG005131 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GALASKO, DOUGLAS R · 1985 to 2018
$55.4M
Neuropathology CoreP30AG013854 · NIA · NORTHWESTERN UNIVERSITY AT CHICAGO · PI VASSAR, ROBERT J · 1996 to 2020
$28.9M
Language in Primary Progressive AphasiaR01DC008552 · NIDCD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MESULAM, MAREK-MARSEL M · 2007 to 2021
$8.5M
Re-visiting Methods for MCI Diagnosis to Improve Biomarker and Trial FindingsR01AG049810 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BONDI, MARK W, EDLAND, STEVEN DYAL · 2016 to 2020
$3.7M
Determinants of Neurodegenerative Decline in Primary Progressive AphasiaR01NS075075 · NINDS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI ROGALSKI, EMILY J · 2012 to 2016
$1.7M
Optimizing Outcome Measures for Clin. Trials in Pre-Clinical Alzheimer's DiseaseR03AG047580 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI EDLAND, STEVEN DYAL · 2015 to 2016
$155k
Optimal design and analysis of AD treatmentR03AG034439 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI EDLAND, STEVEN DYAL · 2009 to 2010
$110k
NCATS NIH HHS UL1 TR001442NIA NIH HHS P30 AG013854NIA NIH HHS P50 AG005131NIA NIH HHS R01 AG049810NIA NIH HHS R03 AG034439NIA NIH HHS R03 AG047580NIDCD NIH HHS R01 DC008552NINDS NIH HHS R01 NS075075
6 · The paper itself

Abstract

backgroundAtrophy measures derived from structural MRI are promising outcome measures for early phase clinical trials, especially for rare diseases such as primary progressive aphasia (PPA), where the small available subject pool limits our ability to perform meaningfully powered trials with traditional cognitive and functional outcome measures.

methodsWe investigated a composite atrophy index in 26 PPA participants with longitudinal MRIs separated by two years. Rogalski

resultsThe optimal composite endpoint required 38% fewer subjects to detect the same percent slowing in atrophy than required by the left PSTC endpoint.

conclusionsOptimal composites can increase the power of clinical trials and increase the probability that smaller trials are informative, an observation especially relevant for PPA, but also for related neurodegenerative disorders including Alzheimer's disease.

Indexed as

Alzheimer’s DiseaseClinical TrialComposite EndpointMRIPower CalculationsPPAPrimary Progressive AphasiaRegion of InterestSample SizeStructural Magnetic Resonance Imaging

Identifiers

PMID28345017
PMCPMC5363955

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.