Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease.
Clin Transl Sci
; 12(3): 240-246, 2019 05.
Article
in En
| MEDLINE
| ID: mdl-30706986
ABSTRACT
The Critical Path for Parkinson's (CPP) Imaging Biomarker and Modeling and Simulation working groups aimed to achieve qualification opinion by the European Medicines Agency (EMA) Committee for Medical Products for Human Use (CHMP) for the use of baseline dopamine transporter neuroimaging for patient selection in early Parkinson's disease clinical trials. This paper describes the regulatory science strategy to achieve this goal. CPP is an international consortium of three Parkinson's charities and nine pharmaceutical partners, coordinated by the Critical Path Institute.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Parkinson Disease
/
Biomarkers
/
Clinical Trials as Topic
/
Dopamine Plasma Membrane Transport Proteins
/
Neuroimaging
Limits:
Humans
Language:
En
Journal:
Clin Transl Sci
Year:
2019
Document type:
Article
Affiliation country: