Atypical ParkinsonismCAPNCT03368300
Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans
A study testing Clinical and biological exam in people with Atypical Parkinsonism, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atypical Parkinsonism
- What is being tested?
- Clinical and biological exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Aug 2012to 3 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 10Show fewer
- 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
Who cannot join
- 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 -
Trial locations and contacts
2 sites in 2 countries.
Mélanie PETAPERMAL, Monito manager contact
2 sites in 2 countries
French Guiana1 site, 1 recruiting
- Recruiting
University Hospital of Guyana
Cayenne, 97306
Dominique MARNET, PH, 05 94 39 51 46 ext. (+0594), domminique.marnet@ch-cayenne.fr
Martinique1 site, 1 recruiting
- Recruiting
University Hospital of Martinique
Fort-de-France, 97261
Régine EDRAGAS, PH, 05 96 720482 ext. (+596), nakapmireil@yahoo.fr
About this study
The primary aim of this study is to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana.
Read the 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.
- Conditions
- Atypical Parkinsonism
- Being tested
- Clinical and biological exam
- Keywords
- progressive supranuclear palsy, Caribbean atypical Parkinsonism, Annona Muricata
- Medical subject headings
- Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and biological examOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Parkinson's patient Receives: Other: Clinical and biological exam |
| witnesses: without parkinson's disease | Other | Subjects without parkinson's disease Receives: Other: Clinical and biological exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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;
Collection of :
administrative and socioeconomic data, medical consultation with video recording , recording oculomotor to the atypical neuropsychological balance assessment ,
- Clinical diagnostic criteria
- Compilation of functional indicators of motor and cognitive autonomy and Collection of intercurrent medical events
- Food and exposure questionnaire
- Neuropsychological assessment
- Recording of oculomotor movements and Post-mortem analysis
- biological collection (plasma, DNA, serum)
Measured: 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 ;
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 ,
Measured: 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;
Neuropsychological assessment Food and exposure survey
Measured: 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);
Neuropsychological assessment Food and exposure survey
Measured: Through study completion, an average of 11 years
to determine the latency of cognitive decline in idiopathic Parkinson's disease in the 3 areas ;
Recording of oculomotor movements and Post-mortem analysis (sampling of blood and cutaneous biopsy to establish a collection of biological samples)
Measured: Through study completion, an average of 11 years, post-mortem analysis after death if applicable
to constitute a biological collection (plasma, DNA, serum).
biological collection (plasma, DNA, serum)
Measured: At the end of the Period of inclusion, around 5-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start3 Aug 2012
- Primary completion3 Aug 2018 (estimated)
- Study completion3 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atypical ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annie LANNUZEL, PU-PH, Study director, University Hospital of GuadeloupeRégine EDRAGAS, PH, Principal investigator, University Hospital of MartiniqueDominique MARNET, PH, Principal investigator, : University Hospital of Guyana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368300
- Sponsor's protocol ID
- RBM-PAP-2011/86
- Acronym
- CAP
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mameri T, Edragas R, Chavonnet A, Tressieres B, Dragin L, Lackmy A, Pelonde-Erimee V, Gaete S, Hierso R, Pouget P, Roze E, Michel PP, Lannuzel A. Higher serum uric acid associates with better cognitive performance and survival in Caribbean parkinsonism. J Neural Transm (Vienna). 2026 Sep 2. doi: 10.1007/s00702-026-03229-6. Online ahead of print.
PubMed 42684476Ribeyron L, Petit A, Edragas R, Belson S, Tressieres B, Bachoud-Levi AC, Remy P, Roze E, Cleret de Langavant L, Lannuzel A. The Clinical Effect of Annonaceae Fruit Consumption on Caribbean Parkinson's Disease Severity. Behav Neurol. 2026;2026(1):e8897550. doi: 10.1155/bn/8897550.
PubMed 42192274
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans
- ClinicalTrials.gov ID
- NCT03368300
- Acronym / sponsor ID
- CAP / RBM-PAP-2011/86
- Conditions
- Atypical Parkinsonism
- Keywords
- progressive supranuclear palsy, Caribbean atypical Parkinsonism, Annona Muricata
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 3 Aug 2012 (actual)
- Primary completion
- 3 Aug 2018 (estimated)
- Study completion
- 3 Aug 2023 (estimated)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Clinical and biological examParkinson's patient |
| witnesses: without parkinson's disease | Other | Other: Clinical and biological examSubjects without parkinson's disease |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pour les patients :
Key exclusion criteria (7 listed)
- 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
- Personnes présentant des troubles cognitifs ou un syndrome parkinsonien diagnostiqué.
- Patient non affilié au régime de sécurité sociale -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and biological examThe 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 | Patients, witnesses: without parkinson's disease |
Primary outcome
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
6 secondary outcomes
to compare the proportion of atypical forms within parkinsonian syndromes;
Time frame: 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
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
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
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
to constitute a biological collection (plasma, DNA, serum).
Time frame: At the end of the Period of inclusion, around 5-6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Derived from this study: PubMed 42684476Mameri T, Edragas R, Chavonnet A, Tressieres B, Dragin L, Lackmy A, Pelonde-Erimee V, Gaete S, Hierso R, Pouget P, Roze E, Michel PP, Lannuzel A. Higher serum uric acid associates with better cognitive performance and survival in Caribbean parkinsonism. J Neural Transm (Vienna). 2026 Sep 2. doi: 10.1007/s00702-026-03229-6. Online ahead of print.
- Derived from this study: PubMed 42192274Ribeyron L, Petit A, Edragas R, Belson S, Tressieres B, Bachoud-Levi AC, Remy P, Roze E, Cleret de Langavant L, Lannuzel A. The Clinical Effect of Annonaceae Fruit Consumption on Caribbean Parkinson's Disease Severity. Behav Neurol. 2026;2026(1):e8897550. doi: 10.1155/bn/8897550.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie PETAPERMAL, Monito manager contact
Annie LANNUZEL, PU-PH study director
University Hospital of Guadeloupe
Régine EDRAGAS, PH principal investigator
University Hospital of Martinique
Dominique MARNET, PH principal investigator
: University Hospital of Guyana
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and biological exam in people with Atypical Parkinsonism, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in French Guiana, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie HAMONY SOTER, Project leader (0590 93 46 86 ext. +590, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03368300, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.