The syndrom 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 neurodegenrative disorder with a severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the Meynert basalis nucleus. This could participate to the occurence of the distractibility in these patients. The aim of this study is to evaluate the effect of the donezepil, an anticholinesterasic, on the distractibility in PSP patients, by using oculomotor and neuropsychological assessments.

Condition	Intervention	Phase
Distractibility Oculomotor testing Neuropsychological scores Motor disability (UPDRS)	Drug: donezepil	Phase II

Ages Eligible for Study:  30 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with PSP
• Age > 30 years
• Disease duration < 5 years
• MMS > 24
• Antisaccades % : 40-80%

Exclusion Criteria:

• Others parkinsonian syndromes
• MMS < 24

Please refer to this study by ClinicalTrials.gov identifier  NCT00139373

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

France
      Centre d''''Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE, Paris,  75013,  France; Recruiting

Study chairs or principal investigators

Bertrand Gaymard, MD, PhD,  Principal Investigator,  INSERM-U679   

Study ID Numbers:  RBM0323
Last Updated:  August 30, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00139373
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-06