Subjects participating in a Parkinson Disease cohort are offered to undergo a PET imaging scan requiring an intravenous diagnostic drug (florbetaben) with the aim of identifying markers of disease progressio

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 18.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004129-15-ES
• Lead Sponsor: Institute for Neurodegenerative Disorders

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-24
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects included in the PPMI protocol:
prodromal PD patients
age above 60
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified