| February 14, 2008 |
| July 8, 2009 |
| January 2008 |
| October 2010 (final data collection date for primary outcome measure) |
- Predefined adverse events (AEs) due, or potentially due, to worsening of PD motor symptoms (tremor, muscle rigidity, bradykinesia, fall) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
- Study drug discontinuations due to predefined AEs that are due, or potentially due, to worsening of PD motor symptoms (tremor, muscle rigidity, bradykinesia, fall) [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
|
- Predefined adverse events (AEs) due, or potentially due, to worsening of PD motor symptoms (tremor, muscle rigidity, bradykinesia, fall)
- Study drug discontinuations due to predefined AEs that are due, or potentially due, to worsening of PD motor symptoms (tremor, muscle rigidity, bradykinesia, fall)
|
| Complete list of historical versions of study NCT00623103 on ClinicalTrials.gov Archive Site |
- Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III motor examination scores at Weeks 8, 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 8, 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: Yes ]
- Change in Mattis Dementia Rating Scale (Mattis DRS-2) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
- Change in Ten Point Clock Test (TPCT) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
- Change in Neuropsychiatric Inventory-10 (NPI-10) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
- Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: No ]
- Change in UPDRS Part V stage (Modified Hoehn and Yahr Staging)at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline [ Time Frame: At Weeks 16, 24, 52 and 76 (or early discontinuation) ] [ Designated as safety issue: Yes ]
|
- Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III motor examination scores at Weeks 8, 16, 24, 52 and 76 (or early discontinuation) compared to baseline
- Change in Mattis Dementia Rating Scale (Mattis DRS-2) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline
- Change in Ten Point Clock Test (TPCT) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline
- Change in Neuropsychiatric Inventory-10 (NPI-10) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline
- Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) scores at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline
- Change in UPDRS Part V stage (Modified Hoehn and Yahr Staging)at Weeks 16, 24, 52 and 76 (or early discontinuation) compared to baseline
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| |
| Long-Term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-Severe Dementia Associated With Parkinson's Disease (PDD) |
| 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) |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Parkinson's Disease Dementia |
- Drug: Rivastigmine capsule
- Drug: Rivastigmine transdermal patch
|
| |
| |
| |
| Active, not recruiting |
| 550 |
|
| October 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 ≤ 24 (at Screening Visit only)
Exclusion Criteria:
- 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. |
| Both |
| 50 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Turkey, United Kingdom |
| |
| NCT00623103 |
| External Affairs, Novartis |
| CENA713B2315 |
| Novartis |
|
| Study Director: |
Novartis Pharmaceuticals |
Novartis Pharmaceuticals |
|
|
| Novartis |
| July 2009 |