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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00623103
• Date of registration: 14/02/2008
• Primary sponsor: Novartis
• Public title: Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
• Scientific title: 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)
• Date of first enrolment: January 2008
• Target sample size: 583
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00623103
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease Dementia

Intervention(s)

Drug: Rivastigmine capsule

Drug: Rivastigmine transdermal patch

Primary Outcome(s)

Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) [Time Frame: 76 Weeks]

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) [Time Frame: 76 Weeks]

Secondary Outcome(s)

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: From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)]

Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline [Time Frame: From Baseline to Weeks 16, 24, 52 and 76]

Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline [Time Frame: At Week 16, 24, 52 and 76 (or early discontinuation)]

Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline [Time Frame: From Baseline to Weeks 16, 24, 52 and 76]

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: From Baseline to Weeks 8, 16, 24, 52 and 76]

UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation) [Time Frame: From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)]

Secondary ID(s)

CENA713B2315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors