Trial document




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  DRKS00008301

Trial Description

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Title

DESCRIBE - DZNE - clinical registry study of neurodegenerative disorders

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Trial Acronym

DESCRIBE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is the use of results of clinical examinations obtained during the regular course of patient care together with the results of analyses on biomaterials (blood, cerebrospinal fluid and urine) including genetic studies for scientific purposes and thus to expand the knowledge of neurodegenerative diseases.

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Brief Summary in Scientific Language

The aim of this study is to establish a clinical register to represent clinic, history, genetics and pathophysiology of neurodegenerative diseases (Alzheimer Disease, fronto-temporal dementia, Parkinson disease, progressive supranuclear palsy, amyotrophic lateral sclerosis, ataxias) and cerebro-vascular originated diseases (after stroke amyloid angiopathy).
This enables the analyses of both individual diseases (eg Parkinson's disease) as well as across diseases (eg Parkinson's and Alzheimer's disease).
In the longitudinal study, the course of the particular disease is documented through annual visits to permit a detailed phenotyping of subjects.
Adjacent to anamnesis, the use of clinical and psychiatric scales and clinical examination (incl. MRI and PET scans) as part of a standardized routine diagnostic, expanded data collection by the additional sampling of biomaterial, the standardized implementation of MRT as well as supplemental analyses of oculomotor function, gait, balance and speach.
Depending on the present disease, additionally to the cognitive performance (eg CERAD test battery) even motor skills and questionnaires used to detect depressive symptoms or sleeping behaviour will be evaluated.
Furthermore, an informant named by the subject is asked about the symptoms of the subject in everyday life.

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Organizational Data

  •   DRKS00008301
  •   2015/09/16
  •   [---]*
  •   yes
  •   Approved
  •   311/14, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G30.0 -  Alzheimer disease with early onset
  •   G30.1 -  Alzheimer disease with late onset
  •   G30.8 -  Other Alzheimer disease
  •   G30.9 -  Alzheimer disease, unspecified
  •   G20 -  Parkinson disease
  •   G21 -  Secondary parkinsonism
  •   G22 -  Parkinsonism in diseases classified elsewhere
  •   G31.82 -  [generalization G31.8: Other specified degenerative diseases of nervous system]
  •   G23.1 -  Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]
  •   G11.1 -  Early-onset cerebellar ataxia
  •   G11.0 -  Congenital nonprogressive ataxia
  •   G11.2 -  Late-onset cerebellar ataxia
  •   G11.3 -  Cerebellar ataxia with defective DNA repair
  •   G11.4 -  Hereditary spastic paraplegia
  •   G11.8 -  Other hereditary ataxias
  •   G11.9 -  Hereditary ataxia, unspecified
  •   G12.2 -  Motor neuron disease
  •   vascular dementia
  •   Stroke
  •   I68.0 -  Cerebral amyloid angiopathy
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Interventions/Observational Groups

  •   Registration of clinical features, process, genetics and pathophysiology of neurodegenerative diseases and cerebro-vascular originated diseases.
    Documentation of progress through annual visits.
    Use of clinical and psychiatric scales, clinical examination (incl. MRI and PET scans), sampling of biomaterial (blood, cerebrospinal fluid and urine), analysis of oculomotor function, gait and balance and speech.
    Depending on the present disease, cognitive performance (eg CERAD test battery) and motor skills are evaluated and questionnaires used to detect depressive symptoms or sleeping behaviour will be evaluated.
    An informant named by the subject is asked about the symptoms of the subject in everyday life.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of this study is to establish a clinical register to represent clinic, history, genetics and pathophysiology of neurodegenerative diseases (Alzheimer Disease, fronto-temporal dementia, Parkinson disease, progressive supranuclear palsy, amyotrophic lateral sclerosis, ataxias) and cerebro-vascular originated diseases (after stroke amyloid angiopathy). In the long term the development of neurodegenerative diseases are better understood through the analysis of data and the possibilities of early and differential diagnosis can be improved. Annual follow-up visits are pursued.

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Secondary Outcome

Another aim of the DESCRIBE Register trial is quickly well-characterized participants to contact for participating in other studies, where the people have agreed to this approach.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/31
  •   [---]*
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- informed consent
- diagnosis of a neurodegenerative disorder or a cerebro-vascular disease
-Consent of the legal representative and Co-Consent for incapacitated subjects

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Exclusion Criteria

- clinically unstable or serious diseases - existing or past passed mental, psychiatric or physical illness that by the opinion of the study physician precludes participation in the study --------------------------------------------------- --------------- exclusion criteria for the optional MRI scan: - electrical implants such as pacemakers or perfusion pumps - pregnancy and pronounced claustrophobia - concomitant medications that have a strong sedating effect - presence of ferromagnetic or electrically conductive implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, flaps with metal parts, metal pieces, large tattoos, permanent makeup or steel implants

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Addresses

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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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    • Deutsches Zentrum für Neurodegenerative Erkrankungen DZNE e.V.c/o Klinik für Neurologie
    • Mr.  Prof. Dr. med.  Thomas  Klockgether 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • Germany
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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
    • Ms.  Verena  Pross 
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE)
    • Sigmund-Freud-Str. 27
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.