Trial document




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  DRKS00005388

Trial Description

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Title

Connectivity changes as a pathological link between striatal and cortical metabolism in subtypes of patients with Parkinson's disease. A multimodal longitudinal study.

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Trial Acronym

KFO 219 TP 10

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URL of the Trial

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Brief Summary in Lay Language

Clinical subtypes of patients with Parkinson’s Disease show differences in disease progress. This mismatch points to differences in the cause of the disease. By a combination of different imaging techniques ([18F]FDG-PET, [18F]F-DOPA-PET, fMRI) in the same patient we aim to highlight these differences. PET is based on a radioactive tracer, whereas magnetic fields are used to assemble an MRI. Additionally we obtain blood samples in order to define genetic (genomics) and metabolomic (metabolomics) changes. We plan to include 65 patients with Parkinson’s Disease and 20 healthy controls. By analysing specific clusters of functionally correlated brain regions in relation to clinical progress we aim to define various subtypes of PD. By the comparison of data at baseline and 2-year-follow up we are able to analyse the time course and gain information about disease-specific changes. Mechanisms of functional compensation are to be demonstrated. The aim of identifying specific subtypes of PD by using different imaging patterns possibly has a high predictive value in relation to diagnosing Parkinson’s disease and its progress.

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Brief Summary in Scientific Language

- Identification of clinic, genetic, metabolomic and imaging clusters to identify subtypes in PD.
- Analysis of connections between the dopaminergic deficit, changes in functional connectivity and neuronal cortical dysfunction within subtypes.
- Identification of functional compensatory strategies.
- Implimentation of imaging techniques as a potential biomarker in clinical prediction.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005388
  •   2013/11/08
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  •   yes
  •   Approved
  •   12-265, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson's disease
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Interventions/Observational Groups

  •   65 Patients with Parkinson's Disease at baseline and 2-year-follow-up, samples of blood, urine and saliva, FDG-PET, F-DOPA-PET, resting state MRI, PANDA, MMST, BDI II, FOG-Q, NMS Scale, PDQ-39, PD Sleep Scale, UPDRS III OFF+ON
  •   20 healthy subjects at baseline, FDG-PET, F-DOPA-PET, resting state MRI
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Identification and presentation of genetic and metabolomic changes and significantly changed connectivity in cerebral networks, which differ in between subtypes of parkinsons disease. We compare imaging data ([18F]FDG-PET,[18F]Dopa-PET,rsMRT) and clinical data of patients and healthy controls at baseline and of patients at baseline and 2-year-follow-up.

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Secondary Outcome

//

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/06/03
  •   85
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   80   Years
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Additional Inclusion Criteria

Patients with PD: A diagnosis of Parkinson's Disease meeting the British Brain Bank Criterias; Hoehn & Yahr I-II; A tolerable withdraw of 12 hours of non retarded dopaminergic medication or of 72 hours of retarded medication, respectivly; Age 55 - 80 y; Good command of german; Written informed consent
Healthy controls: Age > 55 y; Written informed consent

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Exclusion Criteria

Patients with PD: Existence of a disease which affect the cognition; Depression (BDI > 20 points); Dementia (PANDA < 14 points), Imcompliance; Containdications for MRI: cardiac pacemaker, artificial cardiac valve, internal metalic objects, pregnancy, during the period of lactation, claustrophobia, adipositas (BMI > 30)
Healthy controls: Neurological diseases; treatment with drugs affecting the CNS, which cannot be withdrawed at least 12 hours before testing; Containdications for MRI: cardiac pacemaker, artificial cardiac valve, internal metalic objects, pregnancy, during the period of lactation, claustrophobia, adipositas (BMI > 30)

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Addresses

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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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