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NCT Number: NCT02038608

Compensatory Mechanisms in Parkinson Disease (PD)

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Attributes Disease Progression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET

Device

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Pathophysiology of Non Motor Signs and Compensatory Mechanisms in Parkinson's Disease: Role of the Serotoninergic and Dopaminergic Lesions Studied by PET

Acronym: CompensationPD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2014
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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