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Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139373
First Posted: August 31, 2005
Last Update Posted: September 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Estimated Enrollment: 16
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with PSP
  • Age > 30 years old
  • Disease duration < 5 years
  • Mini mental state (MMS) > 24
  • Antisaccades %: 40-80%

Exclusion Criteria:

  • Other parkinsonian syndromes
  • MMS < 24
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139373


Contacts
Contact: Bertrand Gaymard, MD, PhD 33-142162218 gaymard@ccr.jussieu.fr
Contact: Sophie Rivaud-Pechoux, PhD 33-142162218 rivaud@ccr.jussieu.fr

Locations
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         
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Bertrand Gaymard, MD, PhD INSERM-U679
  More Information

ClinicalTrials.gov Identifier: NCT00139373     History of Changes
Other Study ID Numbers: RBM0323
First Submitted: August 30, 2005
First Posted: August 31, 2005
Last Update Posted: September 14, 2007
Last Verified: July 2005

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Progressive supranuclear palsy
Frontal lobe
Oculomotor testing
Neuropsychological scores
Motor disability (UPDRS)
Distractibility

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents