Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans (CAP)

December 5, 2017 updated by: Centre Hospitalier Universitaire de Pointe-a-Pitre
The primary aim of this study is to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • French Guiana
      • Cayenne, French Guiana, 97306
  • Martinique
      • Fort-de-France, Martinique, 97261
        • Recruiting
        • University Hospital of Martinique
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 ,

  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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Pointe-a-Pitre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominique MARNET, PH, : University Hospital of Guyana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBM-PAP-2011/86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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