ArticleJournal of Parkinson's disease2019
The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease.
Article in Journal of Parkinson's disease, 2019. 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 19 papers.
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.
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.
Who cites it
19 citing papers in PubMed.
- Evaluating dopamine transporter imaging as an enrichment biomarker in a phase 2 Parkinson's disease trial.BMC neurology · 2021Trial
- Simplified quantification of [Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2021Trial
- Rethinking the concept of disease modification in an evolving Parkinson's disease treatment landscape.Journal of Parkinson's disease · 2026Review
- Dopaminergic Radiopharmaceutical Imaging in Parkinsonian Syndromes: From Molecular Targets to Clinical Decision-Making.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Multimodal neuroimaging and AI integration in cognitive disorders: advances, challenges, and future directions for precision medicine.Psychoradiology · 2026Review
- Beyond Alzheimer's disease-translating biomarker insights across CNS diseases.Science translational medicine · 2025Review
- [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025Article
- Circulating microRNAs as promising testicular translatable safety biomarkers: current state and future perspectives.Archives of toxicology · 2023Review
- Longitudinal clinical and biomarker characteristics of non-manifesting LRRK2 G2019S carriers in the PPMI cohort.NPJ Parkinson's disease · 2022Article
- Molecular Imaging in Parkinsonian Disorders-What's New and Hot?Brain sciences · 2022Review
- Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?Clinical pharmacology and therapeutics · 2022Review
- The meaning of significant mean group differences for biomarker discovery.PLoS computational biology · 2021Article
- Do caffeine and more selective adenosine AParkinsonism & related disorders · 2020Review
- Approaches to Disease Modification for Parkinson's Disease: Clinical Trials and Lessons Learned.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020Review
- Ioflupane 123I (DAT scan) SPECT identifies dopamine receptor dysfunction early in the disease course in progressive apraxia of speech.Journal of neurology · 2020Article
- Open Data Revolution in Clinical Research: Opportunities and Challenges.Clinical and translational science · 2020Review
- Neurofilament light chain level in plasma extracellular vesicles and Parkinson's disease.Therapeutic advances in neurological disorders · 2020Article
- Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.Digital biomarkers · 2020Review
- Autophagic- and Lysosomal-Related Biomarkers for Parkinson's Disease: Lights and Shadows.Cells · 2019Review
Corrections and comments
- Erratum issued
Authors and funding
25 authors.
Funding
Abstract
As therapeutic trials target early stages of Parkinson's disease (PD), appropriate patient selection based purely on clinical criteria poses significant challenges. Members of the Critical Path for Parkinson's Consortium formally submitted documentation to the European Medicines Agency (EMA) supporting the use of Dopamine Transporter (DAT) neuroimaging in early PD. Regulatory documents included a comprehensive literature review, a proposed analysis plan of both observational and clinical trial data, and an assessment of biomarker reproducibility and reliability. The research plan included longitudinal analysis of the Parkinson Research Examination of CEP-1347 Trial (PRECEPT) and the Parkinson's Progression Markers Initiative (PPMI) study to estimate the degree of enrichment achieved and impact on future trials in subjects with early motor PD. The presence of reduced striatal DAT binding based on visual reads of single photon emission tomography (SPECT) scans in early motor PD subjects was an independent predictor of faster decline in UPDRS Parts II and III as compared to subjects with scans without evidence of dopaminergic deficit (SWEDD) over 24 months. The EMA issued in 2018 a full Qualification Opinion for the use of DAT as an enrichment biomarker in PD trials targeting subjects with early motor symptoms. Exclusion of SWEDD subjects in future clinical trials targeting early motor PD subjects aims to enrich clinical trial populations with idiopathic PD patients, improve statistical power, and exclude subjects who are unlikely to progress clinically from being exposed to novel test therapeutics.
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What OpenQuestion holds
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.