ClinicalTrials.gg
CompletedNCT02214862[F18]-FDDNPUpdated Feb 4, 2016

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

An Early Phase 1 interventional study of [F18]-FDDNP in Progressive Supranuclear Palsy, Multi-System Atrophy and Parkinsonism, sponsored by Fundacion Clinic per a la Recerca Biomédica. Completed at 1 site in Spain. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-02-04.

Sponsored by Fundacion Clinic per a la Recerca Biomédica · Early Phase 1 and Interventional

Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Supranuclear Palsy, Progressive with a site in Spain — 3 open to participants now, 5 under way, 1 of them phase 3. Supranuclear Palsy, Progressive · Spain.

Enrollment
8th of 11
40 · median 146
Started
2013
the only one that year
Phase 1
3 of 12
none open now
Registered
2nd of 12
by date
Lead sponsor
1 of 12
Fundacion Clinic per a la Recerca Biomédica

Among the 12 studies in Supranuclear Palsy, Progressive with a site in Spain, this one is the 8th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2013, is one of 3 in phase 1, and was the 2nd registered.

Supranuclear Palsy, Progressive

171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.

This study's enrollment of 40 is close to the median of 43 across 102 interventional studies indexed under Supranuclear Palsy, Progressive.

Browse Supranuclear Palsy, Progressive studies →

Open to participants now

3 of the 12 studies in Supranuclear Palsy, Progressive with a site in Spain are open now.

All 3 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 38 Supranuclear Palsy, Progressive studies recruiting now, 22 (58%) set no upper age limit and 2 (5%) stop at 75 or younger; 5 take children under 18; 14 take healthy volunteers.

This study: 40 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Supranuclear Palsy, Progressive with a site in Spain, or all of them as a file.
02

Study 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
03

Conditions studied

  • Progressive Supranuclear Palsy
  • Multi-System Atrophy
  • Parkinsonism

Keywords

  • Unclassifiable Parkinsonism, [F18]-FDDNP-PET, Tauopathy, PSP,MSA
04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (> 2 times the , 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 product or any of its components;
  • The subject has a clinically severe active disease, with a hope reduced life;
  • The subject is claustrophobic / a.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Early Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • Drug[F18]-FDDNP

    radiopharmaceutical tracer

    Also known as: 22-(1-{6-[(2-[F-18]fluoroethyl) (methyl)amino]-2-naphthyl} ethylidene) malononitrile

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Hospital Clinic
    Barcelona, 08036, Spain
08

References and documents

Publications

  • Katzenschlager R, Cardozo A, Avila Cobo MR, Tolosa E, Lees AJ. Unclassifiable parkinsonism in two European tertiary referral centres for movement disorders. Mov Disord. 2003 Oct;18(10):1123-31. doi: 10.1002/mds.10523. PubMed 14534915 ↗
  • Litvan I, Bhatia KP, Burn DJ, Goetz CG, Lang AE, McKeith I, Quinn N, Sethi KD, Shults C, Wenning GK; Movement Disorders Society Scientific Issues Committee. Movement Disorders Society Scientific Issues Committee report: SIC Task Force appraisal of clinical diagnostic criteria for Parkinsonian disorders. Mov Disord. 2003 May;18(5):467-86. doi: 10.1002/mds.10459. PubMed 12722160 ↗
  • Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15. PubMed 18725592 ↗
  • Golbe LI, Ohman-Strickland PA. A clinical rating scale for progressive supranuclear palsy. Brain. 2007 Jun;130(Pt 6):1552-65. doi: 10.1093/brain/awm032. Epub 2007 Apr 2. PubMed 17405767 ↗
  • Wenning GK, Tison F, Seppi K, Sampaio C, Diem A, Yekhlef F, Ghorayeb I, Ory F, Galitzky M, Scaravilli T, Bozi M, Colosimo C, Gilman S, Shults CW, Quinn NP, Rascol O, Poewe W; Multiple System Atrophy Study Group. Development and validation of the Unified Multiple System Atrophy Rating Scale (UMSARS). Mov Disord. 2004 Dec;19(12):1391-402. doi: 10.1002/mds.20255. PubMed 15452868 ↗
  • Wong KP, Wardak M, Shao W, Dahlbom M, Kepe V, Liu J, Satyamurthy N, Small GW, Barrio JR, Huang SC. Quantitative analysis of [18F]FDDNP PET using subcortical white matter as reference region. Eur J Nucl Med Mol Imaging. 2010 Mar;37(3):575-88. doi: 10.1007/s00259-009-1293-8. Epub 2009 Oct 31. PubMed 19882153 ↗
  • Buongiorno M, Compta Y, Marti MJ. Amyloid-beta and tau biomarkers in Parkinson's disease-dementia. J Neurol Sci. 2011 Nov 15;310(1-2):25-30. doi: 10.1016/j.jns.2011.06.046. Epub 2011 Jul 20. PubMed 21764078 ↗
  • Smid LM, Vovko TD, Popovic M, Petric A, Kepe V, Barrio JR, Vidmar G, Bresjanac M. The 2,6-disubstituted naphthalene derivative FDDNP labeling reliably predicts Congo red birefringence of protein deposits in brain sections of selected human neurodegenerative diseases. Brain Pathol. 2006 Apr;16(2):124-30. doi: 10.1111/j.1750-3639.2006.00006.x. PubMed 16768752 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Dec 2015 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2014
First posted
Aug 12, 2014
Start
Mar 2013
Primary completionActual
Dec 2015
CompletionActual
Feb 2016
Last update
Feb 4, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02214862
Lead sponsor
Fundacion Clinic per a la Recerca Biomédica
Responsible party
Maria Jose Martí (MD, PhD, Fundacion Clinic per a la Recerca Biomédica) — Principal investigator
First posted
Aug 12, 2014
Start date
Mar 2013
Primary completion
Dec 2015
Completion
Feb 2016
Last update
Feb 4, 2016

Study contacts

Maria Jose Martí, Md, PhD
principal investigator · Fundació per a la Recerca Biomedica

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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