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| Sponsor: | Groupe Hospitalier Pitie-Salpetriere |
|---|---|
| Collaborator: |
Institut National de la Santé Et de la Recherche Médicale, France |
| Information provided by: | Groupe Hospitalier Pitie-Salpetriere |
| ClinicalTrials.gov Identifier: | NCT00139373 |
Purpose
The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in the occurrence of the distractibility in these patients. The aim of this study is to evaluate the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients, by using oculomotor and neuropsychological assessments.
| Condition | Intervention | Phase |
|---|---|---|
|
Supranuclear Palsy, Progressive |
Drug: donepezil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy |
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bertrand Gaymard, MD, PhD | 33-142162218 | gaymard@ccr.jussieu.fr |
| Contact: Sophie Rivaud-Pechoux, PhD | 33-142162218 | rivaud@ccr.jussieu.fr |
| France | |
| Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE | Recruiting |
| PARIS, France, 75013 | |
| Contact: Marie-Laure Welter, MD 33-42161950 marie-laure.welter@psl.aphp.fr | |
| Contact: Bertrand Gaymard, MD, PhD 33-142162218 gaymard@ccr.jussieu.fr | |
| Principal Investigator: Bertrand Gaymard, MD, PhD | |
| Principal Investigator: | Bertrand Gaymard, MD, PhD | INSERM-U679 |
More Information
| Study ID Numbers: | RBM0323 |
| Study First Received: | August 30, 2005 |
| Last Updated: | September 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00139373 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Progressive supranuclear palsy Frontal lobe Oculomotor testing |
Neuropsychological scores Motor disability (UPDRS) Distractibility |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Basal Ganglia Diseases Physiological Effects of Drugs Neurodegenerative Diseases Brain Diseases Cholinergic Agents Ocular Motility Disorders Signs and Symptoms Movement Disorders Therapeutic Uses Donepezil Nootropic Agents |
Eye Diseases Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Ophthalmoplegia Pharmacologic Actions Paralysis Cholinesterase Inhibitors Supranuclear Palsy, Progressive Neurologic Manifestations Cranial Nerve Diseases Tauopathies Central Nervous System Agents |
