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Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Primary Purpose

Supranuclear Palsy, Progressive

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

donepezil

About this trial

This is an interventional treatment trial for Supranuclear Palsy, Progressive focused on measuring Progressive supranuclear palsy, Frontal lobe, Oculomotor testing, Neuropsychological scores, Motor disability (UPDRS), Distractibility

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERERecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00139373

First Posted

August 30, 2005

Last Updated

September 12, 2007

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT00139373

Brief Title

Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Official Title

Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2005

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Supranuclear Palsy, Progressive

Keywords

Progressive supranuclear palsy, Frontal lobe, Oculomotor testing, Neuropsychological scores, Motor disability (UPDRS), Distractibility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

donepezil

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bertrand Gaymard, MD, PhD

Phone

33-142162218

gaymard@ccr.jussieu.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie Rivaud-Pechoux, PhD

Phone

33-142162218

rivaud@ccr.jussieu.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bertrand Gaymard, MD, PhD

Organizational Affiliation

INSERM-U679

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Laure Welter, MD

Phone

33-42161950

marie-laure.welter@psl.aphp.fr

First Name & Middle Initial & Last Name & Degree

Bertrand Gaymard, MD, PhD

Phone

33-142162218

gaymard@ccr.jussieu.fr

First Name & Middle Initial & Last Name & Degree

Bertrand Gaymard, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

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