ArticleClinical and translational science2018
Dopamine Transporter Neuroimaging as an Enrichment Biomarker in Early Parkinson's Disease Clinical Trials: A Disease Progression Modeling Analysis.
Article in Clinical and translational science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
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Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Guideline
- Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial.BMC neurology · 2021Trial
- Empowering Clinical Development With Disease Progression Modeling: Recommendations From the Clinical Trials Transformation Initiative.Clinical and translational science · 2026Article
- Comparison of SZ-HRX and LEHR collimators for reduced-duration 123I-ioflupane brain SPECT/CT: a phantom study.EJNMMI physics · 2025Article
- Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting Report.Pharmaceutical research · 2025Article
- The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making.Clinical pharmacology and therapeutics · 2025Review
- Bioavailability as Proof to Authorize the Clinical Testing of Neurodegenerative Drugs-Protocols and Advice for the FDA to Meet the ALS Act Vision.International journal of molecular sciences · 2024Review
- Prognostic biomarkers in prodromal α-synucleinopathies: DAT binding and REM sleep without atonia.Journal of neurology, neurosurgery, and psychiatry · 2023Observational
- Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies.Clinical and translational science · 2023Review
- Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial.Trials · 2022Article
- Role of Disease Progression Models in Drug Development.Pharmaceutical research · 2022Review
- Stratification Tools for Disease-Modifying Trials in Prodromal Synucleinopathy.Movement disorders : official journal of the Movement Disorder Society · 2022Article
- Article
- Therapeutics in the Pipeline TargetingPharmacological reviews · 2022Review
- Dopamine Transporter Imaging, Current Status of a Potential Biomarker: A Comprehensive Review.International journal of molecular sciences · 2021Review
- The Use, Standardization, and Interpretation of Brain Imaging Data in Clinical Trials of Neurodegenerative Disorders.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- Dopaminergic imaging and clinical predictors for phenoconversion of REM sleep behaviour disorder.Brain : a journal of neurology · 2021Article
- Approaches to Disease Modification for Parkinson's Disease: Clinical Trials and Lessons Learned.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020Review
- Open Data Revolution in Clinical Research: Opportunities and Challenges.Clinical and translational science · 2020Review
- Next-Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development.Clinical pharmacology and therapeutics · 2020Review
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
Given the recognition that disease-modifying therapies should focus on earlier Parkinson's disease stages, trial enrollment based purely on clinical criteria poses significant challenges. The goal herein was to determine the utility of dopamine transporter neuroimaging as an enrichment biomarker in early motor Parkinson's disease clinical trials. Patient-level longitudinal data of 672 subjects with early-stage Parkinson's disease in the Parkinson's Progression Markers Initiative (PPMI) observational study and the Parkinson Research Examination of CEP-1347 Trial (PRECEPT) clinical trial were utilized in a linear mixed-effects model analysis. The rate of worsening in the motor scores between subjects with or without a scan without evidence of dopamine transporter deficit was different both statistically and clinically. The average difference in the change from baseline of motor scores at 24 months between biomarker statuses was -3.16 (90% confidence interval [CI] = -0.96 to -5.42) points. Dopamine transporter imaging could identify subjects with a steeper worsening of the motor scores, allowing trial enrichment and 24% reduction of sample size.
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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.