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2-(1-{6-[(2-[F-18]Fluoroethyl) (Methyl)Amino]-2-naphthyl} Ethylidene) Malononitrile-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism ([F18]-FDDNP)

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ClinicalTrials.gov Identifier: NCT02214862
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Maria Jose Martí, Fundacion Clinic per a la Recerca Biomédica

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

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Multi-System Atrophy Parkinsonism Drug: [F18]-FDDNP Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot, Exploratory Study With [F18]-FDDNP-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: [F18]-FDDNP
2-(1-{6-[(2-[F-18]fluoroethyl) (methyl)amino]-2-naphthyl} ethylidene) malononitrile Radiopharmaceutical tracer, intravenous, single dose of 360+/-20 megabecquerel
Drug: [F18]-FDDNP
radiopharmaceutical tracer
Other Name: 22-(1-{6-[(2-[F-18]fluoroethyl) (methyl)amino]-2-naphthyl} ethylidene) malononitrile




Primary Outcome Measures :
  1. 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. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. to assess the uptake of [18F]-FDDNP in cases clinically defined of progressive supranuclear palsy and multi-system atrophy [ Time Frame: Baseline assessment ]
  2. To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of PET -[18F]-FDDNP. [ Time Frame: 18 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214862


Locations
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Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
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Principal Investigator: Maria Jose Martí, Md, PhD Fundació per a la Recerca Biomedica

Publications:

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Responsible Party: Maria Jose Martí, MD, PhD, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02214862     History of Changes
Other Study ID Numbers: PI11/02031
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Maria Jose Martí, Fundacion Clinic per a la Recerca Biomédica:
Unclassifiable Parkinsonism, [F18]-FDDNP-PET, Tauopathy, PSP,MSA
Additional relevant MeSH terms:
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Multiple System Atrophy
Brain Diseases
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Tauopathies
Atrophy
Pathological Conditions, Anatomical
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Primary Dysautonomias
Autonomic Nervous System Diseases
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action