Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was  Recruiting
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere Identifier:
First received: August 30, 2005
Last updated: September 12, 2007
Last verified: July 2005
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
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

Resource links provided by NLM:

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

Estimated Enrollment: 16

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00139373

Contact: Bertrand Gaymard, MD, PhD 33-142162218
Contact: Sophie Rivaud-Pechoux, PhD 33-142162218

Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE Recruiting
Paris, France, 75013
Contact: Marie-Laure Welter, MD    33-42161950   
Contact: Bertrand Gaymard, MD, PhD    33-142162218   
Principal Investigator: Bertrand Gaymard, MD, PhD         
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Bertrand Gaymard, MD, PhD INSERM-U679
  More Information 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Neurodegenerative Diseases
Eye Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents processed this record on October 20, 2016