Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans
NCT ID: NCT03368300
Last Updated: 2017-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
550 participants
INTERVENTIONAL
2012-08-03
2023-08-03
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
OTHER
NONE
Study Groups
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Patients
Parkinson's patient
Clinical and biological exam
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).
witnesses: without parkinson's disease
Subjects without parkinson's disease
Clinical and biological exam
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).
Interventions
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Clinical and biological exam
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).
Eligibility Criteria
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Inclusion Criteria
1. Patient ou tiers responsable ayant reçu une information sur l'étude et ayant signé le consentement éclairé
2. Patient âgé de plus de 18 ans
3. Patient consultant en neurologie ou en gériatrie pour symptomatologie parkinsonienne ou pour troubles cognitifs évocateurs d'une démence à corps de Lewy
4. Patient domicilié aux Antilles-Guyane
Pour les témoins :
5. Conjoint ou accompagnant ayant reçu une information sur l'étude et ayant signé le consentement éclairé
6. Personne âgée de plus de 18 ans
7. Personne ne présentant pas de pathologie d'allure neurodégénérative (Parkinson, démence notamment)
8. Personne domiciliée aux Antilles-Guyane
Exclusion Criteria
1. Syndrome parkinsonien secondaire (post-traumatique, vasculaire, iatrogène, post encéphalitique)
2. Patient non affilié au régime de sécurité sociale
3. En cas de difficulté de suivi le patient sera exclu de l'étude longitudinale
Pour les témoins :
1. Personnes présentant des troubles cognitifs ou un syndrome parkinsonien diagnostiqué.
2. Patient non affilié au régime de sécurité sociale -
19 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de la Guadeloupe
OTHER
Responsible Party
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Principal Investigators
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Annie LANNUZEL, PU-PH
Role: STUDY_DIRECTOR
University Hospital of Guadeloupe
Régine EDRAGAS, PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Martinique
Dominique MARNET, PH
Role: PRINCIPAL_INVESTIGATOR
: University Hospital of Guyana
Locations
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University Hospital of Guyana
Cayenne, , French Guiana
University Hospital of Martinique
Fort-de-France, , Martinique
Countries
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Central Contacts
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Facility Contacts
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Dominique MARNET, PH
Role: primary
Régine EDRAGAS, PH
Role: primary
Other Identifiers
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RBM-PAP-2011/86
Identifier Type: -
Identifier Source: org_study_id