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Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

G

Groupe Hospitalier Pitie-Salpetriere

Status and phase

Unknown
Phase 2

Conditions

Supranuclear Palsy, Progressive

Treatments

Drug: donepezil

Study type

Interventional

Funder types

Other

Identifiers

NCT00139373
RBM0323

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Sophie Rivaud-Pechoux, PhD; Bertrand Gaymard, MD, PhD

Data sourced from clinicaltrials.gov

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