Trial document




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  DRKS00017454

Trial Description

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Title

Freiburg registry for parkinsonian syndroms and dementias

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Trial Acronym

FReePD

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URL of the Trial

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Brief Summary in Lay Language

The aim of this registry study is to gain further insights into the course of parkinsonian syndromes and dementias, especially in early stages of the diseases to derive an optimal approach to an early and correct diagnosis. A second aim is to compare sensitivity and specificity of different methods in the differentiation of parkinsonism an dementias.
Differentiation is difficult because there is a large overlap in symptomes. However, prognosis and the individual course of the diseases largely differ. That is why we want to investigate these disorders together.
This registry records clinical findings, electrophysiological examinations, transcranial sonography, lab-results of cerebral spinal fluid, report of neuropsychological testing, video and algorithm-based analysis of movement, imaging and report data of the departments of neuroradiology, nuclear medicine and ophthalmology. Additionally a video of a physical examination is recorded for a better evaluation of the progress of the disease over time. All recorded data can just be accessed by approved study investigators.
Additionally to clinical routine every patient receives an investigation of the retina using optical coherence tomography angiography. This method records without contrast agent or radiation a detailed three-dimensional image of the retina on a cellular basis.
In the course of yearly routine visits in our hospital physical examinations and video-documentations are recorded for follow-up evaluation. In the recent years several subtypes of the above mentioned disorders have been postulated. By this structured approach we aim to identify further subtypes of the parkinsonian syndromes and dementias as well as to correlate imaging findings with neurological deficits.

All patients with a parkinsonian syndrome or a dementia, treated in the outpatient or inpatient clinic of the department of neurology at the university hospital of Freiburg or the Parkinson Clinic Ortenau can be enrolled.

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Brief Summary in Scientific Language

Neurodegenerative parkinsonian syndromes are classified in the classic Parkinson’s disease (PD) and atypical parkinsonian syndromes (aPS). The atypical parkinsonian syndroms include the alpha-synucleinopathy multiple system atrophy (MSA) and the tauopathies corticobasal degeneration (CBD) and progressive supranuclear palsy (PSP). Further more PD is often associated with mild cognitive impairment (PD-MCI), which can convert into PD with a dementia (PDD). PD, PD-MCI, PDD and dementia with Lewy bodies (DLB) can be summarized as the continuum of Lewy-body disease (LBD). Dementias represent another spectrum of neurodegenerative disorders, the most frequent dementia is alzheimer's disease, another neurodegenerative dementia is frontotemporal dementia. These neurodegenerative disorders are opposed by dementias not triggered by neurodegeneration, e.g. due to severe microangiopathy. Differentiation between parkinsonian syndromes or dementias is of highest importance for the investigator as well as for the patient since the course of these disorders differs in prognosis and clinical symptoms. Up to now there is no cure for neurodegenerative parkinsonian syndromes or dementias, excluding normal pressure hydrocephalus. The diagnostic criteria are mainly based on clinical findings
(Colosimo et al. 2001, Postuma et al. 2015, Höglinger et al. 2017, McKhann et al. 2011). Da sich diese jedoch erst im Krankheitsverlauf deutlich entwickeln und die Befunderhebung untersucherabhängig ist, liegt die Genauigkeit der gestellten klinischen Diagnosen z.B. bei M. Parkinson nur bei ca. 80 %. (Rizzo et al. 2016, Knopmann et al. 2001). The value of additional diagnostic diagnostic procedures among each other is still unclear. Making an accurate diagnosis is made more difficult by further sub-forms of these disorders with differing phenotypes (Williams et al. 2005). In addition to the procedures established in routine diagnostics, e.g. FDG-PET or MRI, optical coherence tomography has developed into a promising, radiation-free procedure in the differential diagnosis of neurodegenerative diseases (Kim et al. 2017, Ahn et a. 2018)
By the structured approach of this registry we aim to identify further subtypes of the parkinsonian syndromes and dementias as well as to correlate imaging findings with neurological deficits. Additionally we want to gain further insights into the value of the different diagnostic procedures.

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Organizational Data

  •   DRKS00017454
  •   2019/06/12
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  •   yes
  •   Approved
  •   100/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   G23.9 -  Degenerative disease of basal ganglia, unspecified
  •   G23.2 -  Multiple system atrophy, parkinsonian type [MSA-P]
  •   G23.1 -  Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]
  •   G31.82 -  [generalization G31.8: Other specified degenerative diseases of nervous system]
  •   G30 -  Alzheimer disease
  •   G31.0 -  Circumscribed brain atrophy
  •   G91.2 -  Normal-pressure hydrocephalus
  •   G23.3 -  Multiple system atrophy, cerebellar type [MSA-C]
  •   I67.3 -  Progressive vascular leukoencephalopathy
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Interventions/Observational Groups

  •   In this study all clinical findings and reports of additional diagnostics are stored in a database. Additionally every patient receives video documentation of a physical examination as well as an optical coherence tomography (OCT) of the retina. Data of follow-up visits in clinical routine is acquired as well.

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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Comparison of different imaging modalities in the diagnosis of parkinson syndromes and dementias

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Secondary Outcome

- association of findings of different imaging modalities with clinical phenotypes
- Comparison of different imaging modalities regarding the prognosis of parkinson syndromes and dementias
- Using an interdisciplinary approach, further specific phenotypes of parkinson syndromes and dementias can be investigated
- Assessment of the sensitivity and specificity of magnetic resonance imaging (MRI) in the differentiation between Parkinson's disease, atypical Parkinson syndromes and dementia in the course of the disease
- Assessment of sensitivity and specificity of MRI in the differentiation between multisystem atrophy, progressive supranuclear palsy, corticobasal degeneration
- Determining the quality of video-assisted and algorithm-based movement analysis in the differentiation of parkinsonian syndromes and dementias
- Association of the findings of the movement analysis with atrophy patterns or
altered metabolism in cerebral imaging
- Determination of the value of optical coherence tomography and optical coherence tomography angiography in the differentiation of parkinson syndromes and dementias

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2019/06/13
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Presentation of a parkinson syndrome or a dementia in one of the participating study centers

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Exclusion Criteria

No possibility for oral and written consent

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Addresses

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    • Klinik für Neurologie und NeurophysiologieUniversitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Cornelius  Weiller 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Parkinson-Klinik-Ortenau
    • Mr.  Prof. Dr.  Wolfgang  Jost 
    • Kreuzbergstraße 12
    • 77709  Wolfach
    • Germany
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    • Klinik für NeurologieUniversitätsklinikum Freiburg
    • Mr.  Dr.  Nils  Schröter 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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    • Klinik für NeurologieUniversitätsklinikum Freiburg
    • Mr.  Dr.  Nils  Schröter 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.