Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans (CAP)
Primary Purpose
Atypical Parkinsonism
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clinical and biological exam
Sponsored by
About this trial
This is an interventional other trial for Atypical Parkinsonism focused on measuring progressive supranuclear palsy, Caribbean atypical Parkinsonism, Annona Muricata
Eligibility Criteria
Inclusion Criteria:
Pour les patients :
- Patient ou tiers responsable ayant reçu une information sur l'étude et ayant signé le consentement éclairé
- Patient âgé de plus de 18 ans
- Patient consultant en neurologie ou en gériatrie pour symptomatologie parkinsonienne ou pour troubles cognitifs évocateurs d'une démence à corps de Lewy
Patient domicilié aux Antilles-Guyane
Pour les témoins :
- Conjoint ou accompagnant ayant reçu une information sur l'étude et ayant signé le consentement éclairé
- Personne âgée de plus de 18 ans
- Personne ne présentant pas de pathologie d'allure neurodégénérative (Parkinson, démence notamment)
- Personne domiciliée aux Antilles-Guyane
Exclusion Criteria:
Pour les patients :
- Syndrome parkinsonien secondaire (post-traumatique, vasculaire, iatrogène, post encéphalitique)
- Patient non affilié au régime de sécurité sociale
- En cas de difficulté de suivi le patient sera exclu de l'étude longitudinale
Pour les témoins :
- Personnes présentant des troubles cognitifs ou un syndrome parkinsonien diagnostiqué.
- Patient non affilié au régime de sécurité sociale -
Sites / Locations
- University Hospital of GuyanaRecruiting
- University Hospital of MartiniqueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients
witnesses: without parkinson's disease
Arm Description
Parkinson's patient
Subjects without parkinson's disease
Outcomes
Primary Outcome Measures
to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana
Collection of :
administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical
Secondary Outcome Measures
to compare the proportion of atypical forms within parkinsonian syndromes;
Collection of :
administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical neuropsychological balance assessment ,
Clinical diagnostic criteria
Compilation of functional indicators of motor and cognitive autonomy and Collection of intercurrent medical events
Food and exposure questionnaire
Neuropsychological assessment
Recording of oculomotor movements and Post-mortem analysis
biological collection (plasma, DNA, serum)
to characterize the entity "Parkinson-dementia complex" described in Guadeloupe ; to characterize the entity "Parkinson-dementia complex" described in Guadeloupe ;
Compilation of functional indicators of motor and cognitive autonomy and Collection of intercurrent medical events.
Collection of :
administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical neuropsychological balance assessment ,
to determine the natural history of typical and atypical forms of parkinsonism by following a cohort of the incident cases only;
Neuropsychological assessment Food and exposure survey
to determine the implication of a toxic alimentary factor in the etiopathogenesis of atypical forms and compare the results in the 3 areas (Guadeloupe, Guyane, Martinique);
Neuropsychological assessment Food and exposure survey
to determine the latency of cognitive decline in idiopathic Parkinson's disease in the 3 areas ;
Recording of oculomotor movements and Post-mortem analysis (sampling of blood and cutaneous biopsy to establish a collection of biological samples)
to constitute a biological collection (plasma, DNA, serum).
biological collection (plasma, DNA, serum)
Full Information
NCT ID
NCT03368300
First Posted
November 24, 2017
Last Updated
December 5, 2017
Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
1. Study Identification
Unique Protocol Identification Number
NCT03368300
Brief Title
Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans
Acronym
CAP
Official Title
Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2012 (Actual)
Primary Completion Date
August 3, 2018 (Anticipated)
Study Completion Date
August 3, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary aim of this study is to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana.
Detailed Description
An atypical akineto-rigid parkinsonian syndrome, unresponsive to L-dopa has been evidenced in Guadeloupe. Abnormally frequent, this progressive supranuclear palsy (PSP)-like syndrome represents a new clinical entity. Unlike in classical PSP 70% of patients have myoclonus, 59% hallucinations, 78% REM sleep behavior disorders. Oculomotor pattern differs from classical PSP suggesting that cortical dysfunction predominates over brainstem impairments. Neuropathological examination in four patients has shown a widespread accumulation of the tau protein in the basal ganglia, the midbrain and cortical areas.
This syndrome has been associated to the regular consumption of food products derived from plants of the Annonaceae family, more specifically Annona Muricata (soursop), suggesting a toxic origin. We have already confirmed the neurotoxic potential of the lipophilic mitochondrial complex I inhibitor annonacin, the major acetogenin in Annona muricata. This class of compounds is specific to Annonaceae. Nanomolar concentrations of annonacin induce the death of dopaminergic neurons in culture, by impairment of energy production. Chronic systemic intoxication of rats with annonacin causes neuronal damage in the same brain regions that are damaged in patients with atypical parkinsonism. These results greatly suggest that the consumption of annonacea might contribute to the pathogenesis of the disease. The H1 subhaplotype in tau gene associated with PSP in Caucasians did not confer risk for PSP-like atypical parkinsonism in Guadeloupe.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Parkinsonism
Keywords
progressive supranuclear palsy, Caribbean atypical Parkinsonism, Annona Muricata
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The primary aim of this study is to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana.
This study has been designed as epidemiological, multicentric transversal descriptive and longitudinal prospective study with biological collection and post-mortem neuropathological sub-study of brain tissue.
Masking
None (Open Label)
Masking Description
Not masking, 2 groups parallel
Allocation
Non-Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
Parkinson's patient
Arm Title
witnesses: without parkinson's disease
Arm Type
Other
Arm Description
Subjects without parkinson's disease
Intervention Type
Other
Intervention Name(s)
Clinical and biological exam
Intervention Description
The study will include a clinical, neuropsychological, oculomotor, food intake and environmental exposure assessment. Blood samples will be taken to constitute a library of plasma, DNA and serum. The harvesting of samples will be part of a subsequent study. Consent for possible post-mortem neuropathological analysis will be proposed.
All the patients accepting it will be followed by a 5-year longitudinal follow-up. The longitudinal follow-up bi-annual and then annual will include a clinical evaluation, a questionnaire of dependence and a questionnaire of monitoring of exposure to certain environmental factors
All controls must answer a questionnaire of environmental exposure factors, oculomotor test, and blood sample (3 collections: DNA, serum, plasma).
Primary Outcome Measure Information:
Title
to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana
Description
Collection of :
administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical
Time Frame
At the end of the Period of inclusion, around 5-6 years
Secondary Outcome Measure Information:
Title
to compare the proportion of atypical forms within parkinsonian syndromes;
Description
Collection of :
administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical neuropsychological balance assessment ,
Clinical diagnostic criteria
Compilation of functional indicators of motor and cognitive autonomy and Collection of intercurrent medical events
Food and exposure questionnaire
Neuropsychological assessment
Recording of oculomotor movements and Post-mortem analysis
biological collection (plasma, DNA, serum)
Time Frame
At the end of the Period of inclusion, around 5-6 years
Title
to characterize the entity "Parkinson-dementia complex" described in Guadeloupe ; to characterize the entity "Parkinson-dementia complex" described in Guadeloupe ;
Description
Compilation of functional indicators of motor and cognitive autonomy and Collection of intercurrent medical events.
Collection of :
administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical neuropsychological balance assessment ,
Time Frame
Through study completion, an average of 11 years
Title
to determine the natural history of typical and atypical forms of parkinsonism by following a cohort of the incident cases only;
Description
Neuropsychological assessment Food and exposure survey
Time Frame
Through study completion, an average of 11 years
Title
to determine the implication of a toxic alimentary factor in the etiopathogenesis of atypical forms and compare the results in the 3 areas (Guadeloupe, Guyane, Martinique);
Description
Neuropsychological assessment Food and exposure survey
Time Frame
Through study completion, an average of 11 years
Title
to determine the latency of cognitive decline in idiopathic Parkinson's disease in the 3 areas ;
Description
Recording of oculomotor movements and Post-mortem analysis (sampling of blood and cutaneous biopsy to establish a collection of biological samples)
Time Frame
Through study completion, an average of 11 years, post-mortem analysis after death if applicable
Title
to constitute a biological collection (plasma, DNA, serum).
Description
biological collection (plasma, DNA, serum)
Time Frame
At the end of the Period of inclusion, around 5-6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pour les patients :
Patient ou tiers responsable ayant reçu une information sur l'étude et ayant signé le consentement éclairé
Patient âgé de plus de 18 ans
Patient consultant en neurologie ou en gériatrie pour symptomatologie parkinsonienne ou pour troubles cognitifs évocateurs d'une démence à corps de Lewy
Patient domicilié aux Antilles-Guyane
Pour les témoins :
Conjoint ou accompagnant ayant reçu une information sur l'étude et ayant signé le consentement éclairé
Personne âgée de plus de 18 ans
Personne ne présentant pas de pathologie d'allure neurodégénérative (Parkinson, démence notamment)
Personne domiciliée aux Antilles-Guyane
Exclusion Criteria:
Pour les patients :
Syndrome parkinsonien secondaire (post-traumatique, vasculaire, iatrogène, post encéphalitique)
Patient non affilié au régime de sécurité sociale
En cas de difficulté de suivi le patient sera exclu de l'étude longitudinale
Pour les témoins :
Personnes présentant des troubles cognitifs ou un syndrome parkinsonien diagnostiqué.
Patient non affilié au régime de sécurité sociale -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie HAMONY SOTER, Project leader
Phone
0590 93 46 86
Ext
+590
Email
valerie.soter@chu-guadeloupe.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie PETAPERMAL, Monito manager
Phone
0590 93 46 86
Ext
+590
Email
melanie.petapermal@chu-guadeloupe.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annie LANNUZEL, PU-PH
Organizational Affiliation
University Hospital of Guadeloupe
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Régine EDRAGAS, PH
Organizational Affiliation
University Hospital of Martinique
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominique MARNET, PH
Organizational Affiliation
: University Hospital of Guyana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Guyana
City
Cayenne
ZIP/Postal Code
97306
Country
French Guiana
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique MARNET, PH
Phone
05 94 39 51 46
Ext
(+0594)
Email
domminique.marnet@ch-cayenne.fr
Facility Name
University Hospital of Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
Martinique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Régine EDRAGAS, PH
Phone
05 96 720482
Ext
(+596)
Email
nakapmireil@yahoo.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans
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