NCT01249768

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

7 years

First QC Date

November 26, 2010

Last Update Submit

March 30, 2016

Conditions

Parkinson's DiseaseAtypical Parkinsonism

Keywords

Prospective studydiagnostic accuracyCSFMRI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Percentage of correct diagnosis for each of the specified ancillary investigations

    36 months

Study Arms (1)

Cohort

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Hypokinetic rigid syndrome
  • Disease duration of maximum 36 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Netherlands

RECRUITING

Related Publications (1)

  • van Rumund A, Aerts MB, Esselink RAJ, Meijer FJA, Verbeek MM, Bloem BR. Parkinson's Disease Diagnostic Observations (PADDO): study rationale and design of a prospective cohort study for early differentiation of parkinsonism. BMC Neurol. 2018 May 16;18(1):69. doi: 10.1186/s12883-018-1072-x.

    PMID: 29764386DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, cerebrospinal fluids

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • M Verbeek, PhD, MSc

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • B Bloem, Prof, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

B Bloem, Prof, MD

CONTACT

b.bloem@neuro.umcn.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. M.B. Aerts

Study Record Dates

First Submitted

November 26, 2010

First Posted

November 30, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2017

Study Completion

July 1, 2018

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

NL(1)