Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | September 1, 2005 | ||||
Last Updated Date | April 18, 2007 | ||||
Start Date † | November 2003 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00142311 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Functional Characterization of Parkin + Patients | ||||
Official Title † | Clinical, Molecular and Metabolic Comparison Between Early Onset Parkinsonian, With or Without Parkin Mutation: Physiopathological Perspectives | ||||
Brief Summary | Parkinson’s disease is one of the most frequent neurodegenerative diseases, and for which the mechanisms remains unknown. Since the implication of susceptibility factors is highly suspect, we have recently shown that one monogenic form due to alterations in the Parkin gene was responsible for an important proportion of early onset familial and isolated cases. Nevertheless, it not has been determined yet the relationship between idiopathic Parkinson’s disease and secondary Parkinson’s disease with a Parkin gene mutation at the clinical, neuropsychological, metabolic and physiopathological levels. For establishing phenotype-genotype correlations, we propose to compare the phenotype of patients carrying a Parkin mutation (parkin « + », n=25) to those of early onset parkinsonians without a Parkin mutation (Parkin ” - ”, n = 25), and for some aspects (neuropsychological, behavioural and psychiatric evaluations) to the healthy brothers and sisters of Parkin cases “+”(n = 25). The evaluation will carry on the clinical aspects (quantification of the parkinsonian syndrome and reactivity to levodopa, neuropsychological, behavioural and psychiatric evaluations), molecular (types of abnormalities in the Parkin gene) and metabolic (PET – tomography by positron emission) of the disease. Parkinson’s disease caused by Parkin gene mutations is associated with an important and homogeneous loss of dopaminergic neurons of the substantia nigra pars compacta, which is different from those observed during the idiopathic Parkinson’s disease. The corresponding dopaminergic deficit should be associated with an excellent reactivity to levodopa, to a cognitive deficit and to behavioural and/or psychiatric attitudes, in relation with the massive alteration of dopaminergic efferences. This multidisciplinary approach on Parkin cases will be performed in the centers for of clinical investigations of Grenoble and Paris, with the help of the French Parkinson’s Disease Study Group, and two centers for TEP (Lyon and Orsay). This project will allow to a better definition of diagnostic criteria of Parkin « + » cases, which will help for the molecular diagnosis in early onset cases, and will study precisely the clinical, psychiatric and metabolic consequences of a massive and homogeneous dopaminergic denervation, which seems to be different of idiopathic Parkinson’s disease. |
||||
Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Observational | ||||
Study Design † | Natural History, Longitudinal, Case Control, Prospective Study | ||||
Condition † | Parkinson's Disease | ||||
Intervention † | |||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Terminated | ||||
Enrollment † | 97 | ||||
Completion Date | September 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria: - Age at onset before 45 Presence of at least two of the three cardinal signs: bradykinesia, rigidity with dental wheel, postural tremor Frank response to L-Dopa (> 30 %) Absence of personal history of meningitis-encephalopathy, neuroleptic treatment, absence of pyramidal, cerebellar or oculomotor signs, absence of dysautonomia or dementia that occurred less than 2 years before the onset of the disease Exclusion of Wilson's disease by usual biological tests Normal cerebral MRI Exclusion Criteria: - Incapacity of the patient to understand and participate in the protocol Patients who present a contraindication to the realization of cerebral MRI (pacemaker, cardiac valve, ustensile of neurosurgery or vascular surgery, intraocular tissue) could not be included in the group of patients with PET. Women in age to procreate could not participate to the study with PET, only if she uses an effective contraception (oestroprogestives or a coil). Furthermore, the dates of PET examinations should be at the beginning of the menstrual cycle. At the first doubt, a dosage of b-HCG will be performed. |
||||
Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | France | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00142311 | ||||
Responsible Party | |||||
Secondary IDs †† | 4CC03H-A02094SP, RAF/03003/P011104/PCR02006 | ||||
Study Sponsor † | Institut National de la Santé Et de la Recherche Médicale, France | ||||
Collaborators †† | Assistance Publique - Hôpitaux de Paris | ||||
Investigators † |
|
||||
Information Provided By | Institut National de la Santé Et de la Recherche Médicale, France | ||||
Verification Date | April 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |