Phase 3
N=583
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Parkinson's Disease Dementia
Bottom Line
View on ClinicalTrials.gov: NCT00623103 ↗Enrolled (actual)
583
Serious AEs
29.2%
Results posted
Nov 2011
Primary outcome: Primary: Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) — 24.5; 9.7; 4.1; 5.2 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivastigmine capsule (Drug); Rivastigmine transdermal patch (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) |
24.5; 9.7; 4.1; 5.2; 5.1; 6.3 | — |
| PRIMARY Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) |
2.4; 0.7; 0.3; 0.3; 1.0; 0.0 | — |
| SECONDARY 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 |
-0.4; -0.9; 0.5; -1.7; 0.1; -1.4 | — |
| SECONDARY Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline |
5.4; 3.4; 6.5; 4.4; 4.6; 1.3 | — |
| SECONDARY Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline |
0.5; 0.4; 0.6; 0.3; 0.3; -0.1 | — |
| SECONDARY Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline |
-3.3; -0.5; -2.6; -1.0; -1.7; -0.3 | — |
| SECONDARY 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 |
-0.4; -1.3; -0.6; -1.5; -2.2; -5.4 | — |
| SECONDARY UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation) |
2.7; 2.7; 2.6; 2.7; 2.8; 2.7 | — |
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 symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.
Eligibility Criteria
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 ≤ 26 (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.
Data sourced from ClinicalTrials.gov (NCT00623103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.