An interventional study of Clinical and biological exam in Atypical Parkinsonism, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Status unknown at 2 sites in 2 countries. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-11.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Not applicable, Interventional, and Other
The primary aim of this study is to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana.
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.
171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.
This study's planned enrollment of 550 is above the median of 43 across 102 interventional studies indexed under Supranuclear Palsy, Progressive.
Browse Supranuclear Palsy, Progressive studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
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Pour les patients :
Patient domicilié aux Antilles-Guyane
Pour les témoins :
Exclusion Criteria:
Pour les patients :
Pour les témoins :
Parkinson's patient
Other: Clinical and biological exam
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).
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
Time frame: At the end of the Period of inclusion, around 5-6 years
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 , 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)
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 ;
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 ,
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;
Neuropsychological assessment Food and exposure survey
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);
Neuropsychological assessment Food and exposure survey
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 ;
Recording of oculomotor movements and Post-mortem analysis (sampling of blood and cutaneous biopsy to establish a collection of biological samples)
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).
biological collection (plasma, DNA, serum)
Time frame: At the end of the Period of inclusion, around 5-6 years
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2012 (actual). Primary completion is estimated for Aug 2018, 72 months after the start.
Of 28 interventional studies with no phase under Supranuclear Palsy, Progressive, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 29. This study's planned 72 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Supranuclear Palsy, Progressive →
Centre Hospitalier Universitaire de la Guadeloupe