Parkinson's Disease, Diagnostic Observations (PADDO)

Parkinson's Disease Clinical Trial

— PADDO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01249768
• Other study ID #: PADDO
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2010
• Last updated: March 30, 2016
• Start date: July 2010
• Est. completion date: July 2018

Study information

• Verified date: March 2016
• Source: Radboud University
• Contact: B Bloem, Prof, MD
• Email: b.bloem[@]neuro.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atypical Parkinsonism
• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of correct diagnosis for each of the specified ancillary investigations	Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism	36 months	No
Secondary	Percentage of correct diagnosis for each of the specified ancillary investigations	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)	36 months	No