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

Evaluation of [18F] florbetaben in subjects participating in the Parkinson?s Progression Markers Initiative (PPMI) Protocol

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004129-15-ES

Enrollment

Unknown

Registered

2016-02-24

Start date

2016-03-07

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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) C

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate 18F florbetaben PET imaging in subjects enrolled in the PPMI protocol (PD, PD genetic cohort, prodromal PD and healthy control subjects);Secondary Objective: Not applicable;Primary end point(s): Evaluation of 18F florbetaben PET imaging as biomarker of PD progression;Timepoint(s) of evaluation of this end point: minute 90-110	—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Spain

Contacts

Public ContactUnidad de trastornos del movimiento

Hospital Clínic de Barcelona

ETOLOSA@clinic.ub.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026