Long-Term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-Severe Dementia Associated With Parkinson's Disease (PDD) - Tabular View

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

July 8, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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)

Change History

Complete list of historical versions of study NCT00623103 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Parkinson's Disease Dementia

Intervention ^ICMJE

Drug: Rivastigmine capsule
Drug: Rivastigmine transdermal patch

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

550

Completion Date

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00623103

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CENA713B2315

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP