- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368300
Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans (CAP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Valérie HAMONY SOTER, Project leader
- Phone Number: +590 0590 93 46 86
- Email: valerie.soter@chu-guadeloupe.fr
Study Contact Backup
- Name: Mélanie PETAPERMAL, Monito manager
- Phone Number: +590 0590 93 46 86
- Email: melanie.petapermal@chu-guadeloupe.fr
Study Locations
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-
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Cayenne, French Guiana, 97306
- Recruiting
- University Hospital of Guyana
-
Contact:
- Dominique MARNET, PH
- Phone Number: (+0594) 05 94 39 51 46
- Email: domminique.marnet@ch-cayenne.fr
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-
-
-
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Fort-de-France, Martinique, 97261
- Recruiting
- University Hospital of Martinique
-
Contact:
- Régine EDRAGAS, PH
- Phone Number: (+596) 05 96 720482
- Email: nakapmireil@yahoo.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients
Parkinson's patient
|
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). |
Other: witnesses: without parkinson's disease
Subjects without parkinson's disease
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana
Time Frame: At the end of the Period of inclusion, around 5-6 years
|
Collection of : administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical |
At the end of the Period of inclusion, around 5-6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to compare the proportion of atypical forms within parkinsonian syndromes;
Time Frame: At the end of the Period of inclusion, around 5-6 years
|
Collection of : administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical neuropsychological balance assessment ,
|
At the end of the Period of inclusion, around 5-6 years
|
to characterize the entity "Parkinson-dementia complex" described in Guadeloupe ; to characterize the entity "Parkinson-dementia complex" described in Guadeloupe ;
Time Frame: Through study completion, an average of 11 years
|
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 , |
Through study completion, an average of 11 years
|
to determine the natural history of typical and atypical forms of parkinsonism by following a cohort of the incident cases only;
Time Frame: Through study completion, an average of 11 years
|
Neuropsychological assessment Food and exposure survey
|
Through study completion, an average of 11 years
|
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);
Time Frame: Through study completion, an average of 11 years
|
Neuropsychological assessment Food and exposure survey
|
Through study completion, an average of 11 years
|
to determine the latency of cognitive decline in idiopathic Parkinson's disease in the 3 areas ;
Time Frame: Through study completion, an average of 11 years, post-mortem analysis after death if applicable
|
Recording of oculomotor movements and Post-mortem analysis (sampling of blood and cutaneous biopsy to establish a collection of biological samples)
|
Through study completion, an average of 11 years, post-mortem analysis after death if applicable
|
to constitute a biological collection (plasma, DNA, serum).
Time Frame: At the end of the Period of inclusion, around 5-6 years
|
biological collection (plasma, DNA, serum)
|
At the end of the Period of inclusion, around 5-6 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dominique MARNET, PH, : University Hospital of Guyana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBM-PAP-2011/86
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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