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

Brief Title

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

Official Title

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

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 [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
    

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

To assess the Relative Volume of Distribution of [18F]-FDDNP in individuals with unclassifiable parkinsonism, and to try to correlate their eventual clinical diagnosis with baseline PET findings.

Secondary Outcome

 to assess the uptake of [18F]-FDDNP in cases clinically defined of progressive supranuclear palsy and multi-system atrophy

Condition

Progressive Supranuclear Palsy

Intervention

[F18]-FDDNP

Study Arms / Comparison Groups

 [F18]-FDDNP

Description:  2-(1-{6-[(2-[F-18]fluoroethyl) (methyl)amino]-2-naphthyl} ethylidene) malononitrile Radiopharmaceutical tracer, intravenous, single dose of 360+/-20 megabecquerel

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

March 2013

Completion Date

February 2016

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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.
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Maria Jose Martí, Md, PhD, , 

Location Countries

Spain

Location Countries

Spain

NCT ID

NCT02214862

Organization ID

PI11/02031

Responsible Party

Principal Investigator

Study Sponsor

Fundacion Clinic per a la Recerca Biomédica

Study Sponsor

Maria Jose Martí, Md, PhD, Principal Investigator, Fundació per a la Recerca Biomedica

Verification Date

February 2016