Status:
COMPLETED
2-(1-{6-[(2-[F-18]Fluoroethyl) (Methyl)Amino]-2-naphthyl} Ethylidene) Malononitrile-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Progressive Supranuclear Palsy
Multi-System Atrophy
Eligibility:
All Genders
40+ years
Phase:
EARLY_PHASE1
Brief 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 \[...
Eligibility Criteria
Inclusion
- The subject is male or female ≥ 40 years old;
- The individual has one of these three conditions:
- probable PSP according to criteria of the National Institute of Neurological Disorders and Stroke (NINDS)
- probable MSA according to criteria of the Second consensus statement on the diagnosis of multiple system atrophy
- unclassifiable parkinsonism according to criteria defined by Katzenschlager et al, 2003:
- Patients with atypical parkinsonism without response to treatment with levodopa and does not meet any of the diagnostic criteria for other known atypical parkinsonism
- Patient given written consent
Exclusion
- The subject is diagnosed with Parkinson's Disease and meets the diagnostic criteria United Kingdom Parkinson's Disease Society Brain Bank -The subject is pregnant or breastfeeding;
- The subject has a history of drug abuse or alcohol;
- The subject has a moderate or severe renal function impairment (creatinine serum\> 1.5 mg / dL);
- The subject has a moderate or severe hepatic impairment (bilirubin\> 2 times the upper limit of normal, transaminases\> 3 times the limit top of normal);
- The subject presents structural abnormalities in the basal ganglia or cortical level on MRI or CT;
- The subject has participated in a clinical study with a pharmaceutical product investigation within 30 days prior to screening and / or a radiopharmaceutical minimum period of 5 radioactive half-lives prior to screening;
- Occupational exposure to radiation\> 15 milliSievert (mSv) / year
- Use of nonsteroidal antiinflammatory drug (NSAIDs), for some reason, can not be replaced by any other drug 4 weeks before the PET scan;
- The subject has allergy investigational product or any of its components;
- The subject has a clinically severe active disease, with a hope reduced life;
- The subject is claustrophobic / a.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02214862
Start Date
March 1 2013
End Date
February 1 2016
Last Update
February 4 2016
Active Locations (1)
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1
Hospital Clinic
Barcelona, Spain, Spain, 08036