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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 February 2016
• Main ID: NCT02214862
• Date of registration: 11/08/2014
• Prospective Registration: No
• Primary sponsor: Fundacion Clinic per a la Recerca Biomédica
• Public title: 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
• Scientific title: Pilot, Exploratory Study With [F18]-FDDNP-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism
• Date of first enrolment: March 2013
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02214862
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label
• Phase: Phase 0

Countries of recruitment

Spain

Contacts

• Name: Maria Jose Martí, Md, PhD
• Affiliation: Fundació per a la Recerca Biomedica

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multi-System Atrophy

Progressive Supranuclear Palsy

Parkinsonism

Intervention(s)

Drug: [F18]-FDDNP

Primary Outcome(s)

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(s)

To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of PET -[18F]-FDDNP. [Time Frame: 18 months]

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

Secondary ID(s)

PI11/02031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors