Evidence map›Paper›PMID 34533239›Full record

ArticleMovement disorders : official journal of the Movement Disorder Society2022

Stratification Tools for Disease-Modifying Trials in Prodromal Synucleinopathy.

Dario Arnaldi, Pietro Mattioli, Francesco Famà, Nicola Girtler, Andrea Brugnolo, Matteo Pardini, Andrea Donniaquio, Federico Massa, Beatrice Orso, Stefano Raffa and 3 more

Abstract read
In one paragraph

Article in Movement disorders : official journal of the Movement Disorder Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

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

9 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Prodromal dementia with Lewy bodies in REM sleep behavior disorder: A multicenter study.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Article
  6. Disease modification in Parkinsonism: obstacles and ways forward.Journal of neural transmission (Vienna, Austria : 1996) · 2022
    Review
  7. Review
  8. Article
  9. Increased Transferrin Sialylation Predicts Phenoconversion in Isolated REM Sleep Behavior Disorder.Movement disorders : official journal of the Movement Disorder Society · 2022
    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

13 authors.

Dario ArnaldiDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.ORCID 0000-0001-6823-6069
Pietro MattioliDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.
Francesco FamàDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.
Nicola GirtlerDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.
Andrea BrugnoloDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.
Matteo PardiniDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.
Andrea DonniaquioDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.
Federico MassaDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.
Beatrice OrsoDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.ORCID 0000-0001-9983-7940
Stefano RaffaDepartment of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.
Matteo BaucknehtIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Silvia MorbelliIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Flavio NobiliDepartment of Neuroscience (DINOGMI), University of Genoa, Genoa, Italy.

Funding

Ministry of Health
6 · The paper itself

Abstract

backgroundDopamine transporter single photon-emission computed tomography (DAT-SPECT) is the strongest risk factor for phenoconversion in patients with idiopathic rapid eye movement (REM)-sleep behavior disorder (iRBD). However, it might be used as a second-line stratification tool in clinical trials, because it is expensive and mini-invasive.

objectiveAim of the study is to investigate whether other cost-effective and non-invasive biomarkers may be proposed as first-line stratification tools.

methodsForty-seven consecutive iRBD patients (68.53 ± 7.16 years, 40 males) underwent baseline clinical and neuropsychological assessment, olfaction test, resting electroencephalogram (EEG), and DAT-SPECT. All patients underwent 6 month-based clinical follow-up to investigate the emergence of parkinsonism and/or dementia. Survival analysis and Cox regression were used to estimate conversion risk.

resultsSeventeen patients developed an overt synucleinopathy (eight Parkinsonism and nine dementia) 32.8 ± 22 months after diagnosis. The strongest risk factors were putamen specific to non-displaceable binding ratio (SBR) (hazard ratio [HR], 7.3), attention/working memory cognitive function (NPS-AT/WM) (HR, 5.9), EEG occipital mean frequency (HR, 2.7) and clinical motor assessment (HR, 2.3). On multivariate Cox-regression analysis, only putamen SBR and NPS-AT/WM significantly contributed to the model (HR, 6.2, 95% confidence interval [CI], 1.9-19.8). At post-hoc analysis, the trail-making test B (TMT-B) was the single most efficient first-line stratification tool that allowed to reduce the number of eligible subjects to 76.6% (sensitivity 1, specificity 0.37). Combining TMT-B and DAT-SPECT further reduced the sample to 66% (sensitivity 0.88, specificity 0.47).

conclusionThe TMT-B seems to be a cost-effective and efficient first-line screening tool, to be used to select patients that deserve DAT-SPECT as second-line screening tool for disease-modifying clinical trials. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

Parkinsonian DisordersREM Sleep Behavior DisorderSynucleinopathiesAgedFemaleHumansMaleMiddle AgedPutamenTomography, Emission-Computed, Single-PhotoncognitiveEEGprodromal synucleinopathyREM sleep behavior disorderSPECT

Identifiers

PMID34533239
PMCPMC9292414

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.