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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00139373 History of Changes |
| Other Study ID Numbers: | RBM0323 |
| Study First Received: | August 30, 2005 |
| Last Updated: | September 12, 2007 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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Progressive supranuclear palsy Frontal lobe Oculomotor testing |
Neuropsychological scores Motor disability (UPDRS) Distractibility |
|
Supranuclear Palsy, Progressive Paralysis Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Neurodegenerative Diseases Neurologic Manifestations |
Eye Diseases Signs and Symptoms Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |