PET Imaging to diagnose of inclassificable parkinsonism

Conditions: Atypical Parkinsonism
MedDRA version: 14.1Level: PTClassification code 10034010Term: ParkinsonismSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-000364-21-ES

Lead Sponsor: Fundació Clínic per a la Recerca Biomédica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

men and women > 40years old
with one of this patologies:
-multisystemic atrophia
-progressive supranuclear paralysis diagnosis by international criteria
-atypical parkinsonism without answer to levodopa treatment and without any diagnosis criteria of atypical parkisonism
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

patient with parkinson disease and parkisonism one year before dementia symptoms
patient with vascular dementia or estructural abnosmalities in RMN or TAC
creatinin > 1.5 ULN
bilirrubin > 2 x ULN or transaminases > 3 x ULN
Previous drugs or alcohol abuse
Previous participation in a investigational stydy 30 days before screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP;Secondary Objective: To characterise a priori the binding of this PET probe in well-defined and classified cases with atypical parkinsonisms with and without underlying tau pathology;Primary end point(s): To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of [18F]-FDDNP;Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To characterise a priori the binding of this PET probe in well-defined and classified cases with atypical parkinsonisms with and without underlying tau pathology;Timepoint(s) of evaluation of this end point: 18 months