Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

Completed · Phase 3

Conditions studied: Parkinson's Disease Dementia

In brief

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.

Key facts

Study ID

NCT00623103

Run by

Novartis

People needed

583

Starts

2008-01-01

Last updated by the study team

2011-11-28

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• 21st Century Neurology — Phoenix, Arizona, United States
• Neurosearch, Inc. — Reseda, California, United States
• Neurosearch II, Inc. — Ventura, California, United States
• Sunrise Clinical Research, Inc. — Hollywood, Florida, United States
• Collier Neurologic Specialists — Naples, Florida, United States
• Comprehensive Neurology Specialists, PC — Suwanee, Georgia, United States
• Neurological Associates — Meridian, Idaho, United States
• Evanstan Northwestern Healthcare Medical Group — Glenview, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Neurological Care of Central NY — Syracuse, New York, United States
• Neurology & Neuroscience Associates, Inc. — Akron, Ohio, United States
• Square 1 Clinical Research — Erie, Pennsylvania, United States
• Research Protocol Management Solutions — Pittsburgh, Pennsylvania, United States
• Neurology Specialists of Dallas — Dallas, Texas, United States
• Progressive Clinical Research — Bountiful, Utah, United States
• Veterans Affairs Puget Sound Health Care System — Seattle, Washington, United States
• 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
• Novartis Investigative Site — Kogarah, New South Wales, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Malvern, Victoria, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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