Parkinson's Disease, Diagnostic Observations (PADDO)

• Conditions: Parkinson's Disease; Atypical Parkinsonism

• Registration Number: NCT01249768
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-11-26
• Study First Submitted QC: 2010-11-26
• Study First Posted: 2010-11-30
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31
• Primary Completion: 2017-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of correct diagnosis for each of the specified ancillary investigations	36 months	Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism

Secondary Outcome Measures

Name	Time	Method
Percentage of correct diagnosis for each of the specified ancillary investigations	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)

Trial Locations

Locations (1)

Radboud University Medical Centre; 🇳🇱 Nijmegen, Netherlands