Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans

NCT03368300 | Unknown DMC

• 1 other identifier: RBM-PAP-2011/86
• Study Type: interventional
• Target: 550
• Locations: 2 countries
• Sites: 2

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.

Conditions

Atypical Parkinsonism

Keywords

progressive supranuclear palsy; Caribbean atypical Parkinsonism; Annona Muricata

Outcome Measures

Primary Outcomes (1)

• 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

  At the end of the Period of inclusion, around 5-6 years

Secondary Outcomes (6)

• to compare the proportion of atypical forms within parkinsonian syndromes;

  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 ;

  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;

  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);

  Through study completion, an average of 11 years

• to determine the latency of cognitive decline in idiopathic Parkinson's disease in the 3 areas ;

  Through study completion, an average of 11 years, post-mortem analysis after death if applicable

Study Arms (2)

Patients

OTHER

Parkinson's patient

Other: Clinical and biological exam

witnesses: without parkinson's disease

OTHER

Subjects without parkinson's disease

Other: Clinical and biological exam

Interventions

Clinical and biological exam OTHER

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).

Patients; witnesses: without parkinson's disease

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (2)

University Hospital of Guyana

Cayenne, 97306, French Guiana

RECRUITING

University Hospital of Martinique

Fort-de-France, 97261, Martinique

RECRUITING

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annie LANNUZEL, PU-PH

  University Hospital of Guadeloupe

  STUDY DIRECTOR

• Régine EDRAGAS, PH

  University Hospital of Martinique

  PRINCIPAL INVESTIGATOR

• Dominique MARNET, PH

  : University Hospital of Guyana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie HAMONY SOTER, Project leader

CONTACT

0590 93 46 86; valerie.soter@chu-guadeloupe.fr

Mélanie PETAPERMAL, Monito manager

CONTACT

0590 93 46 86; melanie.petapermal@chu-guadeloupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Not masking, 2 groups parallel
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 11, 2017
• Study Start: August 3, 2012
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2023
• Last Updated: December 11, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); MA (1)