MedDataX Logo

Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

NCT ID: NCT00139373

Last Updated: 2007-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Supranuclear Palsy, Progressive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

donepezil

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER_GOV

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bertrand Gaymard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

INSERM-U679

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bertrand Gaymard, MD, PhD

Role: CONTACT

[email protected]
33-142162218

Sophie Rivaud-Pechoux, PhD

Role: CONTACT

[email protected]
33-142162218

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marie-Laure Welter, MD

Role: primary

[email protected]
33-42161950

Bertrand Gaymard, MD, PhD

Role: backup

[email protected]
33-142162218

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RBM0323

Identifier Type: -

Identifier Source: org_study_id