A 76-week Prospective, Open-label, Multicenter Study to E... | EligiMed

A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00623103Tipo: INTERVENTIONALInicio: 1 de ene de 2008

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease Society Brain Bank criteria
Diagnosis of Parkinson's disease dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with onset of symptoms of dementia at least 2 years following the first diagnosis of idiopathic Parkinson's disease
Mini Mental State Examination score of ≥10 and ≤ 26 (at Screening Visit only)

Criterios de exclusión

An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations
A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn and Yahr Staging (UPDRS Part V)
A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD
A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.
A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria
A current diagnosis of a major depressive episode according to DSM-IV criteria
A history of stereotaxic brain surgery for Parkinson's disease
A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine or to other cholinergic compounds

Intervenciones

drug

Rivastigmine capsule

Rivastigmine capsules orally twice a day. Target dose 12 mg/day.

drug

Rivastigmine transdermal patch

Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Buenos Aires F.D., Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalNovartis

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