Clinical trial NCT00623103: Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease Dementia
Keywords: Parkinson's disease dementia
cholinesterase inhibitor
rivastigmine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 583
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)
timeFrame: 76 Weeks
measure: 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)
timeFrame: 76 Weeks
Secondary outcomes:
measure: 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
timeFrame: From Baseline to Weeks 8, 16, 24, 52 and 76
measure: Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline
timeFrame: From Baseline to Weeks 16, 24, 52 and 76
measure: Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
timeFrame: From Baseline to Weeks 16, 24, 52 and 76
measure: Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
timeFrame: At Week 16, 24, 52 and 76 (or early discontinuation)
measure: 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
timeFrame: From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)
measure: UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)
timeFrame: From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: 21st Century Neurology
state: Arizona
city: Reseda
country: United States
facility: Neurosearch, Inc.
state: California
city: Ventura
country: United States
facility: Neurosearch II, Inc.
state: California
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Suwanee
country: United States
facility: Comprehensive Neurology Specialists, PC
state: Georgia
city: Meridian
country: United States
facility: Neurological Associates
state: Idaho
city: Glenview
country: United States
facility: Evanstan Northwestern Healthcare Medical Group
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Syracuse
country: United States
facility: Neurological Care of Central NY
state: New York
city: Akron
country: United States
facility: Neurology & Neuroscience Associates, Inc.
state: Ohio
city: Erie
country: United States
facility: Square 1 Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Solutions
state: Pennsylvania
city: Dallas
country: United States
facility: Neurology Specialists of Dallas
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research
state: Utah
city: Seattle
country: United States
facility: Veterans Affairs Puget Sound Health Care System
state: Washington
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Malvern
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Jette
country: Belgium
facility: Novartis Investigative Site
city: Kortrijk
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Kitchener
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regina
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Amiens Cedex
country: France
facility: Novartis Investigative Site
city: Clermont
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Marseille Cedex
country: France
facility: Novartis Investigative Site
city: Montpellier Cedex 5
country: France
facility: Novartis Investigative Site
city: Paris Cedex
country: France
facility: Novartis Investigative Site
city: Pessac Cedex
country: France
facility: Novartis Investigative site
city: Rennes
country: France
facility: Novartis Investigative site
city: Roanne
country: France
facility: Novartis Investigative Site
city: Bad Nauheim
country: Germany
facility: Novartis Investigative Site
city: Beelitz-Heilstaetten
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Goettingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leun-Biskirchen
country: Germany
facility: Novartis Investigative Site
city: Luebben
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wolfach
country: Germany
facility: Novartis Investigative Site
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
state: IS
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
state: LU
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Trieste
country: Italy
facility: Novartis Investigative Site
state: TS
city: Arcugnano
country: Italy
facility: Novartis Investigative Site
state: VI
city: Cassino
country: Italy
facility: Novartis Investigative site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Zwolle
country: Netherlands
facility: Novartis Investigative Site
state: AB
city: Blaricum
country: Netherlands
facility: Novartis Investigative Site
state: AN
city: Maastricht
country: Netherlands
facility: Novartis Investigative Site
state: AZ
city: Breda
country: Netherlands
facility: Novartis Investigative Site
state: CK
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
state: ER
city: Tilburg
country: Netherlands
facility: Novartis Investigative Site
state: GC
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
state: GZ
city: Hertogenbosch
country: Netherlands
facility: Novartis Investigative Site
state: JL
city: Heerlen
country: Netherlands
facility: Novartis Investigative Site
state: PC
city: Sittard
country: Netherlands
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Sihhiye/Ankara
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
city: Blackburn
country: United Kingdom
facility: Novartis Investigative Site
city: Blandford Forum, Dorset
country: United Kingdom
facility: Novartis Investigative Site
city: Christchurch, Dorset
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Peterborough
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
city: Vale of Glamorgan
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: