Evidence map›Paper›PMID 34814867›Full record

Trial reportBMC neurology2021

Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial.

R Matthew Hutchison, Karleyton C Evans, Tara Fox, Minhua Yang, Jerome Barakos, Barry J Bedell, Jesse M Cedarbaum, Miroslaw Brys, Andrew Siderowf, Anthony E Lang

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03318523 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 16% of its field
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.

NCT03318523 phase2terminatednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease

TypeinterventionalSponsorBiogenRan2018 to 2021Enrolled357ConditionsParkinson's DiseaseArmsPlacebo, BIIB054
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 20 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Preclinical evaluation of [EJNMMI research · 2024
    Article
  6. Review
  7. Article
  8. Imaging Dopaminergic Neurotransmission in Neurodegenerative Disorders.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022
    Article
  9. Review
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

10 authors at 5 institutions in 2 countries.

R Matthew HutchisonBiogen, 300 Binney Street, Cambridge, MA, 02142, USA. matthew.hutchison@biogen.com.
Karleyton C EvansBiogen, 300 Binney Street, Cambridge, MA, 02142, USA.
Tara FoxBiogen, Maidenhead, UK.
Minhua YangBiogen, 300 Binney Street, Cambridge, MA, 02142, USA.
Jerome BarakosBioclinica, Princeton, NJ, USA.
Barry J BedellBiospective Inc., Montreal, QC, Canada.
Jesse M CedarbaumCoeruleus Clinical Sciences LLC, Woodbridge, CT, USA.
Miroslaw BrysEli Lilly and Company, Indianapolis, IN, USA.
Andrew SiderowfUniversity of Pennsylvania, Philadelphia, PA, USA.
Anthony E LangMorton and Gloria Shulman Movement Disorders Clinic, Toronto, ON, Canada.
Biogen (United States) · USBioClinica (United States) · USBiogen (United Kingdom) · GBEli Lilly (United States) · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDopamine transporter single-photon emission computed tomography (DaT-SPECT) can quantify the functional integrity of the dopaminergic nerve terminals and has been suggested as an imaging modality to verify the clinical diagnosis of Parkinson's disease (PD). Depending on the stage of progression, approximately 5-15% of participants clinically diagnosed with idiopathic PD have been observed in previous studies to have normal DaT-SPECT patterns. However, the utility of DaT-SPECT in enhancing early PD participant selection in a global, multicenter clinical trial of a potentially disease-modifying therapy is not well understood.

methodsThe SPARK clinical trial was a phase 2 trial of cinpanemab, a monoclonal antibody against alpha-synuclein, in participants with early PD. DaT-SPECT was performed at screening to select participants with DaT-SPECT patterns consistent with degenerative parkinsonism. Acquisition was harmonised across 82 sites. Images were reconstructed and qualitatively read at a central laboratory by blinded neuroradiologists for inclusion prior to automated quantitative analysis.

resultsIn total, 482 unique participants were screened between January 2018 and May 2019; 3.8% (15/398) of imaged participants were excluded owing to negative DaT-SPECT findings (i.e., scans without evidence of dopaminergic deficit [SWEDD]).

conclusionA smaller proportion of SPARK participants were excluded owing to SWEDD status upon DaT-SPECT screening than has been reported in prior studies. Further research is needed to understand the reasons for the low SWEDD rate in this study and whether these results are generalisable to future studies. If supported, the radiation risks, imaging costs, and operational burden of DaT-SPECT for enrichment may be mitigated by clinical assessment and other study design aspects.

trial registrationClinicalTrials.gov identifier: NCT03318523 . Date submitted: October 19, 2017. First Posted: October 24, 2017.

Indexed as

Dopamine Plasma Membrane Transport ProteinsParkinson DiseaseBiomarkersDopamineHumansTomography, Emission-Computed, Single-PhotonBiomarkersDopamineDopamine Plasma Membrane Transport ProteinsBiomarkerDopamine transporterParkinson’s diseaseSPECTSWEDD

Identifiers

PMID34814867
PMCPMC8609885
OpenAlexW3215027240

What OpenQuestion holds

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LicenceCC BY
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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.