Compensatory Mechanisms in Parkinson Disease (PD) (CompensationPD)

September 18, 2015 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hospices Civils de Lyon, Hopital Neurologique Pierre Wertheimer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET
Device: PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This will be achieved at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
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
This will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).
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
These correlations will be determined at the end of the inclusion period, thus 24 to 36 months after study onset (January 2014).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.722

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on PET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe