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Compensatory Mechanisms in Parkinson Disease (PD) (CompensationPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038608
First Posted: January 16, 2014
Last Update Posted: September 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
Parkinson's disease is characterized by a large number of non motor, especially neuropsychiatric, signs. Their pathophysiology is complex but the role of dopaminergic and serotoninergic systems dysfunction is suggested by several studies. In addition, the serotoninergic system is involved in the pathophysiology of dyskinesias. Very few studies have analyzed the abnormalities of these two neurotransmission systems at disease onset, in de novo PD patients. Furthermore, the parallel evolution of the degeneration of the dopaminergic and serotoninergic systems with disease progression remains unknown. Thus the present study aims at determining, by using PET and 11C-PE2I and 11C-DASB the respective role of the serotoninergic and dopaminergic systems dysfunction in motor and non motor manifestations in PD, at different evolution stages.

Condition Intervention
Parkinson's Disease Device: PET

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Respective progression of both dopaminergic and serotoninergic lesions in Parkinson's disease [ Time Frame: This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014). ]
    Dopaminergic lesions will be determined by positron emission tomography (PET) using 11C-PE2I in 3 groups of PD patients (de novo; mid-stage (4-7 years of evolution); late-stage (8-10 years of evolution). Serotoninergic lesions will be assessed by positron emission tomography (PET) using 11C-DASB in the same 3 groups of PD patients. In addition a control group will be included.


Secondary Outcome Measures:
  • Correlations between neuropsychiatric observed in Parkinson's disease at different stages of evolution [ Time Frame: These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014). ]

    Dopaminergic lesions will be determined by positron emission tomography (PET) using 11C-PE2I in 3 groups of PD patients (de novo; mid-stage (4-7 years of evolution); late-stage (8-10 years of evolution). Serotoninergic lesions will be assessed by positron emission tomography (PET) using 11C-DASB in the same 3 groups of PD patients. In addition a control group will be included.

    The neuropsychiatric manifestations studied are :

    • hypo and hyperdopaminergic signs : ECMP scale
    • Apathy using LARS scale
    • Anxiety using BAI scale
    • Depression using BDI scale (Beck Depression Inventory)
    • Affective well-being and asthenia using visual analogic scales of Norris
    • MATHYS scale
    • Global cognitive scale : MATTIS
    • Food behavior using TFEQ scale
    • Personality : TCI-R scale
    • Impulsivity by UPPS scale

  • Role of dopaminergic and serotoninergic lesions in fatigue [ Time Frame: This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014). ]

    : Dopaminergic lesions will be determined by positron emission tomography (PET) using 11C-PE2I in 3 groups of PD patients (de novo; mid-stage (4-7 years of evolution); late-stage (8-10 years of evolution). Serotoninergic lesions will be assessed by positron emission tomography (PET) using 11C-DASB in the same 3 groups of PD patients. In addition a control group will be included.

    Fatigue will be assessed using the PDFS-16 scale


  • Relationship between the severity of dopaminergic and serotoninergic lesions and the quality of life [ Time Frame: These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014). ]

    Dopaminergic lesions will be determined by positron emission tomography (PET) using 11C-PE2I in 3 groups of PD patients (de novo; mid-stage (4-7 years of evolution); late-stage (8-10 years of evolution). Serotoninergic lesions will be assessed by positron emission tomography (PET) using 11C-DASB in the same 3 groups of PD patients. In addition a control group will be included.

    Fatigue will be assessed using the PDQ39 (Parkinson's Disease Questionnaire) scale



Enrollment: 49
Study Start Date: December 2014
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET Device: PET

  Eligibility

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients

  • Patients presenting doparesponsive Parkinson's disease
  • Patient's age between 40 and 70 years old
  • Absence of other neurological or psychiatric disease
  • Absence of cognitive decline ( MATTIS > 130)
  • For women of childbearing age a pregnancy test and a contraceptive method will be required
  • Informed consent sign

Healthy subjects

  • subject's age between 40 and 70 years old
  • Absence of neurological or psychiatric disease
  • Absence of cognitive decline ( MATTIS > 130)
  • For women of childbearing age a pregnancy test and a contraceptive method will be required
  • Informed consent sign

Exclusion Criteria:

Patients

  • patient's age < 40 years old or > 70 years old
  • Other neurological or psychiatric disease
  • Cognitive decline (MATTIS < 130).
  • Having participated to a PET or SPECT study in the last 12 months
  • Pregnancy
  • Severe concomitant disease

Healthy subjects

  • subject's age < 40 years old or > 70 years old
  • Neurological or psychiatric disease
  • Cognitive decline (MATTIS < 130).
  • Having participated to a PET or SPECT study in the last 12 months
  • Pregnancy
  • Severe concomitant disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038608


Locations
France
Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02038608     History of Changes
Other Study ID Numbers: 2012.722
First Submitted: January 13, 2014
First Posted: January 16, 2014
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Hospices Civils de Lyon:
Parkinson
serotonin
dopamine
non motor
progression
PET

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases