E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson's Disease |
Enfermedad de Parkinson |
|
E.1.1.1 | Medical condition in easily understood language |
Parkinson's Disease |
enfermedad de Parkinson |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate 18F florbetaben PET imaging in subjects enrolled in the PPMI protocol (PD, PD genetic cohort, prodromal PD and healthy control subjects) |
Evaluar la imagen obtenida mediante PET con 18F florbetabenen sujetos participantes en el estudio PPMI (con enfermedad de Parkinson, cohorte de EP genética, EP prodrómica y voluntarios sanos) |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
No aplicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects included in the PPMI protocol: prodromal PD patients age above 60 |
Sujetos incluidos en el protocolo PPMI: pacientes con enfermedad de Parkinson prodrómica edad superior a 60 años |
|
E.4 | Principal exclusion criteria |
Any contraindication to have a PET scan performed Known intolerance to the PET tracer [18F] florbetaben and/or its excipients Not having given a separate written informed consent for the PET scanning with [18F] florbetaben Pregnant or lactating |
Cualquier contraindicación para realizar un PET Intolerancia conocida al trazador del PET [18F] florbetaben y/o a sus excipientes No otorgar el consentimiento informado por escrito específico para la realización de el estudio de PET con [18F] florbetaben Embarazo y lactancia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of 18F florbetaben PET imaging as biomarker of PD progression |
Evaluación de la neuroimagen mediante PET con 18F florbetaben como biomarcador de la progresión de la enfermedad de Parkinson |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
minute 90-110 |
minuto 90 a 110 |
|
E.5.2 | Secondary end point(s) |
not applicable |
no aplicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
no aplicable |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |