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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00139373
Other study ID # RBM0323
Secondary ID
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
Est. completion date
Est. primary completion date
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


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, 

See also
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Terminated NCT03068468 - Study of BIIB092 in Participants With Progressive Supranuclear Palsy Phase 2
Recruiting NCT04468932 - Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy N/A
Completed NCT04858893 - Application of Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms
Terminated NCT02658916 - Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003 Phase 1