Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

September 12, 2007 updated by: Groupe Hospitalier Pitie-Salpetriere
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
        • Contact:
        • Principal Investigator:
          • Bertrand Gaymard, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (ESTIMATE)

August 31, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2007

Last Update Submitted That Met QC Criteria

September 12, 2007

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBM0323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Supranuclear Palsy, Progressive

Clinical Trials on donepezil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe