Parkinson's Disease, Diagnostic Observations (PADDO)

NCT ID: NCT01249768

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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Conditions

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Parkinson's Disease Atypical Parkinsonism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marjolein Aerts

dr. M.B. Aerts

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M Verbeek, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

B Bloem, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Medical Centre

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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B Bloem, Prof, MD

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 29764386 (View on PubMed)

Other Identifiers

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PADDO

Identifier Type: -

Identifier Source: org_study_id

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