Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Supranuclear Palsy, Progressive Clinical Trial

Official title:

Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00139373
• Other study ID #: RBM0323
• Status: Recruiting
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: September 12, 2007

Study information

• Verified date: July 2005
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: Bertrand Gaymard, MD, PhD
• Phone: 33-142162218
• Email: gaymard[@]ccr.jussieu.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supranuclear Palsy, Progressive

Intervention

Drug:
• donepezil

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France,