NCT02214862

2-(1-{6-[(2-[F-18]Fluoroethyl) (Methyl)Amino]-2-naphthyl} Ethylidene) Malononitrile-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism

Pilot, Exploratory Study With [F18]-FDDNP-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The PET tracer \[F18\]-FDDNP has a specific affinity for lesions containing tau protein. The study consists of two phases: * In the first (cross-sectional) phase it will be assessed the uptake of \[18F\]-FDDNP in 10 cases with progressive supranuclear palsy (PSP, a tauopathy) en 10 with multi-system atrophy (MSA, a non-tauopathy), along with 20 individuals with Unclassifiable Parkinsonism, as previously defined in a European cohort study. * In the second (longitudinal) phase it will be prospectively followed the 20 unclassifiable patients (at 6, 12 and 18 months) by means of validated scales and accepted diagnostic criteria in order to try to correlate their eventual clinical diagnosis with baseline PET findings. On this basis, we endeavour to estimate the ability of this technique to detect in vivo underlying tau pathology in subjects initially unclassifiable on clinical grounds. We hypothesized that: 1. Patients with clinically definite PSP will present an increased uptake in basal ganglia, brainstem and cerebellum. 2. Patients with clinically defined MSA will not present specific uptake. 3. Part of unclassifiable patients with parkinsonism will present a pattern of uptake similar to patients with clinically defined PSP and this part along the clinical follow-up will be meet clinical criteria for diagnose of PSP

Conditions

• Progressive Supranuclear Palsy
• Multi-System Atrophy
• Parkinsonism

Interventions

Type	Name	Description
DRUG	[F18]-FDDNP	radiopharmaceutical tracer

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2014-08-12
• Last updated: 2016-02-04

Locations

1 site across 1 country: Spain