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 progression

• Register: EUCTR
• Last refreshed on: 18 April 2017
• Main ID: EUCTR2015-004129-15-ES
• Date of registration: 24/02/2016
• Prospective Registration: Yes
• Primary sponsor: Institute for Neurodegenerative Disorders
• Public title: 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 progression
• Scientific title: Evaluation of [18F] florbetaben in subjects participating in the Parkinson?s Progression Markers Initiative (PPMI) Protocol
• Date of first enrolment: 07/03/2016
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004129-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: Unidad de trastornos del movimiento
• Affiliation: Hospital Clínic de Barcelona

• Name: Unidad de trastornos del movimiento
• Affiliation: Hospital Clínic de Barcelona

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Parkinson's Disease
MedDRA version: 18.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Neuraceq
Product Name: 18F florbetaben
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLORBETABEN (18F)
CAS Number: 902143-01-5
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Main Objective: Evaluate 18F florbetaben PET imaging in subjects enrolled in the PPMI protocol (PD, PD genetic cohort, prodromal PD and healthy control subjects)

Primary end point(s): Evaluation of 18F florbetaben PET imaging as biomarker of PD progression

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: minute 90-110

Secondary Outcome(s)

Secondary end point(s): not applicable

Timepoint(s) of evaluation of this end point: not applicable

Secondary ID(s)

[18F]florbetaben-PPMI

Source(s) of Monetary Support

Michael J Fox Foundation for Parkinson's Research