Evidence map›Paper›PMID 33846962›Full record

ReviewNeurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics2021

The Use, Standardization, and Interpretation of Brain Imaging Data in Clinical Trials of Neurodegenerative Disorders.

Adam J Schwarz

Erratum issuedAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  19. Quantification of amyloid PET for future clinical use: a state-of-the-art review.European journal of nuclear medicine and molecular imaging · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

1 author.

Adam J SchwarzTakeda Pharmaceuticals Ltd., 40 Landsdowne Street, Cambridge, MA, 02139, USA. adam.schwarz@takeda.com.ORCID http://orcid.org/0000-0002-9743-6171

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Imaging biomarkers play a wide-ranging role in clinical trials for neurological disorders. This includes selecting the appropriate trial participants, establishing target engagement and mechanism-related pharmacodynamic effect, monitoring safety, and providing evidence of disease modification. In the early stages of clinical drug development, evidence of target engagement and/or downstream pharmacodynamic effect-especially with a clear relationship to dose-can provide confidence that the therapeutic candidate should be advanced to larger and more expensive trials, and can inform the selection of the dose(s) to be further tested, i.e., to "de-risk" the drug development program. In these later-phase trials, evidence that the therapeutic candidate is altering disease-related biomarkers can provide important evidence that the clinical benefit of the compound (if observed) is grounded in meaningful biological changes. The interpretation of disease-related imaging markers, and comparability across different trials and imaging tools, is greatly improved when standardized outcome measures are defined. This standardization should not impinge on scientific advances in the imaging tools per se but provides a common language in which the results generated by these tools are expressed. PET markers of pathological protein aggregates and structural imaging of brain atrophy are common disease-related elements across many neurological disorders. However, PET tracers for pathologies beyond amyloid β and tau are needed, and the interpretability of structural imaging can be enhanced by some simple considerations to guard against the possible confound of pseudo-atrophy. Learnings from much-studied conditions such as Alzheimer's disease and multiple sclerosis will be beneficial as the field embraces rarer diseases.

Indexed as

Data AnalysisBrainClinical Trials as TopicHumansMagnetic Resonance ImagingNeurodegenerative DiseasesNeuroimagingPositron-Emission TomographyClinical trialsImagingMRINeurologyPET

Identifiers

PMID33846962
PMCPMC8423963

What OpenQuestion holds

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Registered trials

None linked

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.