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Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans (CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368300
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Pointe-a-Pitre

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.

Condition or disease Intervention/treatment Phase
Atypical Parkinsonism Other: Clinical and biological exam Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Other
Official Title: Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans
Actual Study Start Date : August 3, 2012
Estimated Primary Completion Date : August 3, 2018
Estimated Study Completion Date : August 3, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients
Parkinson's patient
Other: 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
Other: 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).





Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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 ,

    1. Clinical diagnostic criteria
    2. Compilation of functional indicators of motor and cognitive autonomy and Collection of intercurrent medical events
    3. Food and exposure questionnaire
    4. Neuropsychological assessment
    5. Recording of oculomotor movements and Post-mortem analysis
    6. biological collection (plasma, DNA, serum)

  2. 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 ,


  3. 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

  4. 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

  5. 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)

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pour les patients :

    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:

Pour les patients :

  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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368300


Contacts
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Contact: Valérie HAMONY SOTER, Project leader 0590 93 46 86 ext +590 valerie.soter@chu-guadeloupe.fr
Contact: Mélanie PETAPERMAL, Monito manager 0590 93 46 86 ext +590 melanie.petapermal@chu-guadeloupe.fr

Locations
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French Guiana
University Hospital of Guyana Recruiting
Cayenne, French Guiana, 97306
Contact: Dominique MARNET, PH    05 94 39 51 46 ext (+0594)    domminique.marnet@ch-cayenne.fr   
Martinique
University Hospital of Martinique Recruiting
Fort-de-France, Martinique, 97261
Contact: Régine EDRAGAS, PH    05 96 720482 ext (+596)    nakapmireil@yahoo.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Pointe-a-Pitre
Investigators
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Study Director: Annie LANNUZEL, PU-PH University Hospital of Guadeloupe
Principal Investigator: Régine EDRAGAS, PH University Hospital of Martinique
Principal Investigator: Dominique MARNET, PH : University Hospital of Guyana

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Responsible Party: Centre Hospitalier Universitaire de Pointe-a-Pitre
ClinicalTrials.gov Identifier: NCT03368300    
Other Study ID Numbers: RBM-PAP-2011/86
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Pointe-a-Pitre:
progressive supranuclear palsy
Caribbean atypical Parkinsonism
Annona Muricata
Additional relevant MeSH terms:
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Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders