NCT00139373

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
Last Updated

September 14, 2007

Status Verified

July 1, 2005

First QC Date

August 30, 2005

Last Update Submit

September 12, 2007

Conditions

Supranuclear Palsy, Progressive

Keywords

Progressive supranuclear palsyFrontal lobeOculomotor testingNeuropsychological scoresMotor disability (UPDRS)Distractibility

Interventions

donepezilDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with PSP
  • Age \> 30 years old
  • Disease duration \< 5 years
  • Mini mental state (MMS) \> 24
  • Antisaccades %: 40-80%

You may not qualify if:

  • Other parkinsonian syndromes
  • MMS \< 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Bertrand Gaymard, MD, PhD

    INSERM-U679

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand Gaymard, MD, PhD

CONTACT

33-142162218gaymard@ccr.jussieu.fr

Sophie Rivaud-Pechoux, PhD

CONTACT

33-142162218rivaud@ccr.jussieu.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2005

First Posted

August 31, 2005

Last Updated

September 14, 2007

Record last verified: 2005-07

Locations

FR(1)