Status:
COMPLETED
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Lead Sponsor:
Novartis
Conditions:
Parkinson's Disease Dementia
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT00623103
Start Date
January 1 2008
Last Update
November 28 2011
Active Locations (127)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
21st Century Neurology
Phoenix, Arizona, United States, 85004
3
Neurosearch, Inc.
Reseda, California, United States, 91335
4
Neurosearch II, Inc.
Ventura, California, United States, 93003