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Parkinson's Disease, Diagnostic Observations (PADDO) (PADDO)

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ClinicalTrials.gov Identifier: NCT01249768
Recruitment Status : Recruiting
First Posted : November 30, 2010
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Marjolein Aerts, Radboud University

Brief Summary:

Background:

Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease entities with partly common symptomatology. Especially very early in the course of disease, the differentiation between both disease entities can be challenging, even for specialists in the field of movement disorder. However, the establishment of a correct diagnosis is very important for adequate patientcounseling, treatment and the correct inclusion of patients in research trials. Ancillary diagnostic investigations are looked upon to aid in this diagnostic dilemma.

Objective:

To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.


Condition or disease
Parkinson's Disease Atypical Parkinsonism

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Assessing the Diagnostic Contribution of 3-Tesla MRI, CSF Analysis and a Second Opinion in a Specialized Movement Disorder Centre, in Differentiating Between Parkinson's Disease and Atypical Parkinsonism
Study Start Date : July 2010
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Cohort
The cohort will consist of 150 patients with a hypokinetic rigid syndrome and a disease duration of maximum 36 months



Primary Outcome Measures :
  1. percentage of correct diagnosis for each of the specified ancillary investigations [ Time Frame: 36 months ]
    Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism


Secondary Outcome Measures :
  1. Percentage of correct diagnosis for each of the specified ancillary investigations [ Time Frame: 36 months ]
    Percentage of correct diagnosis for each of the specified ancillary investigations(MRI, CSF analysis, and second opinion) to differentiate between the specific diagnosis (PD, MSA, PSP, CBD, LBD, VaP)


Biospecimen Retention:   Samples With DNA
Whole blood, cerebrospinal fluids


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with a hypokinetic-rigid syndrome with a disease duration of maximum 36 months and in whom a definitive diagnosis has not been established yet.
Criteria

Inclusion Criteria:

  • Hypokinetic rigid syndrome
  • Disease duration of maximum 36 months

Exclusion Criteria:

  • Probable diagnosis of PD without any red flags
  • Probable diagnosis MSA
  • Probable diagnosis PSP
  • Diagnosis CBD
  • Diagnosis DLB
  • Probable diagnosis Vascular Parkinsonism
  • Other neurodegenerative disease than parkinsonism
  • A prior history of brain surgery
  • Instable comorbidity

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): NCT01249768


Contacts
Contact: B Bloem, Prof, MD b.bloem@neuro.umcn.nl

Locations
Netherlands
Radboud University Medical Centre Recruiting
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: M Verbeek, PhD, MSc Radboud University
Principal Investigator: B Bloem, Prof, MD Radboud University

Responsible Party: Marjolein Aerts, dr. M.B. Aerts, Radboud University
ClinicalTrials.gov Identifier: NCT01249768     History of Changes
Other Study ID Numbers: PADDO
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Marjolein Aerts, Radboud University:
Prospective study
diagnostic accuracy
CSF
MRI

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases