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PET Imaging to diagnose of inclassificable parkinsonism

FDDNP-PET FOR IN VIVO DIAGNOSIS OF TAUOPATHY IN UNCLASSIFIABLE PARKINSONISM

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000364-21-ES
Enrollment
Unknown
Registered
2012-08-09
Start date
2012-11-13
Completion date
Unknown
Last updated
2012-12-03

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

Conditions

Atypical Parkinsonism MedDRA version: 14.1 Level: PT Classification code 10034010 Term: Parkinsonism System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: [18F]-Fluoro-ethyl-methyl-amino-naphthyl-ethylidene-malononitrile (FDDNP Product Code: FDDNP Pharmaceutical Form: Injection INN or Proposed INN: [18F]-Fluoro-ethyl-methyl-amino-naphthyl-

Sponsors

Fundació Clínic per a la Recerca Biomédica
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Spain

Contacts

Public ContactUnidad de Parkinson - ICN

Hospital Clinic

mjmarti@clinic.ub.es0034932275786

Outcome results

None listed

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