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Stratification Tools for Disease-Modifying Trials in Prodromal Synucleinopathy.

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The Trail-Making Test B (TMT-B) is an effective, cost-efficient first-line tool for stratifying idiopathic REM-sleep behavior disorder (iRBD) patients. It identifies individuals who may benefit from more expensive DAT-SPECT scans in clinical trials.

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Area of Science:

  • Neuroscience
  • Clinical Neurology
  • Biomarker Discovery

Background:

  • Idiopathic REM-sleep behavior disorder (iRBD) phenoconversion risk is strongly linked to Dopamine Transporter Single Photon-Emission Computed Tomography (DAT-SPECT).
  • DAT-SPECT is costly and invasive, limiting its use as a primary clinical trial stratification tool.

Purpose of the Study:

  • To identify cost-effective, non-invasive biomarkers for first-line stratification in iRBD patients.
  • To evaluate the efficacy of alternative screening tools compared to DAT-SPECT.

Main Methods:

  • Forty-seven iRBD patients underwent clinical, neuropsychological, olfaction, and EEG assessments, alongside DAT-SPECT.
  • Survival analysis and Cox regression models were employed to assess conversion risk to synucleinopathies.
  • Follow-up data was collected for 6-month intervals to monitor for parkinsonism or dementia.

Main Results:

  • Seventeen patients (36%) developed overt synucleinopathy within 32.8 months.
  • Key risk factors identified included putamen SBR (HR 7.3), attention/working memory (HR 5.9), EEG occipital mean frequency (HR 2.7), and motor assessment (HR 2.3).
  • The Trail-Making Test B (TMT-B) emerged as the most efficient first-line tool, reducing the eligible subject pool by 76.6%.

Conclusions:

  • The TMT-B is a viable, cost-effective first-line screening tool for iRBD patients in clinical trials.
  • TMT-B can help select patients for subsequent DAT-SPECT, optimizing resource allocation.
  • Combining TMT-B with DAT-SPECT further refines patient selection for disease-modifying trials.