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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)

NCT ID: NCT00623103

Last Updated: 2011-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

583 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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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

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Conditions

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Parkinson's Disease Dementia

Keywords

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Parkinson's disease dementia cholinesterase inhibitor rivastigmine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rivastigmine capsule

Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76.

Group Type EXPERIMENTAL

Rivastigmine capsule

Intervention Type DRUG

Rivastigmine capsules orally twice a day. Target dose 12 mg/day.

Rivastigmine patch

Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.

Group Type EXPERIMENTAL

Rivastigmine transdermal patch

Intervention Type DRUG

Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period.

Interventions

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Rivastigmine capsule

Rivastigmine capsules orally twice a day. Target dose 12 mg/day.

Intervention Type DRUG

Rivastigmine transdermal patch

Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period.

Intervention Type DRUG

Other Intervention Names

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Exelon® Exelon®

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

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21st Century Neurology

Phoenix, Arizona, United States

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Neurosearch, Inc.

Reseda, California, United States

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Neurosearch II, Inc.

Ventura, California, United States

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Sunrise Clinical Research, Inc.

Hollywood, Florida, United States

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Collier Neurologic Specialists

Naples, Florida, United States

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Comprehensive Neurology Specialists, PC

Suwanee, Georgia, United States

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Neurological Associates

Meridian, Idaho, United States

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Evanstan Northwestern Healthcare Medical Group

Glenview, Illinois, United States

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University of Kansas Medical Center

Kansas City, Kansas, United States

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Neurological Care of Central NY

Syracuse, New York, United States

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Neurology & Neuroscience Associates, Inc.

Akron, Ohio, United States

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Square 1 Clinical Research

Erie, Pennsylvania, United States

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Research Protocol Management Solutions

Pittsburgh, Pennsylvania, United States

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Neurology Specialists of Dallas

Dallas, Texas, United States

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Progressive Clinical Research

Bountiful, Utah, United States

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Veterans Affairs Puget Sound Health Care System

Seattle, Washington, United States

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Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Bs As, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires F.D., Argentina

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Rosario, Santa Fe Province, Argentina

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Kogarah, New South Wales, Australia

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Heidelberg, Victoria, Australia

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Malvern, Victoria, Australia

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Melbourne, Victoria, Australia

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Prahran, Victoria, Australia

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Graz, , Austria

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Innsbruck, , Austria

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Linz, , Austria

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Linz, , Austria

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Vienna, , Austria

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Antwerp, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Jette, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Wilrijk, , Belgium

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Regina, Saskatchewan, Canada

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Amiens, , France

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Clermont, , France

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Lille, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Pessac, , France

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Rennes, , France

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Roanne, , France

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Bad Nauheim, , Germany

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Beelitz-Heilstätten, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Dresden, , Germany

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Göttingen, , Germany

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Hamburg, , Germany

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Kassel, , Germany

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Leipzig, , Germany

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Leun-Biskirchen, , Germany

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Lubin, , Germany

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Mainz, , Germany

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Marburg, , Germany

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München, , Germany

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München, , Germany

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Nuremberg, , Germany

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Ulm, , Germany

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Ulm, , Germany

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Wolfach, , Germany

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Bari, BA, Italy

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Bologna, BO, Italy

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Brescia, BS, Italy

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Foggia, FG, Italy

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Pozzilli, IS, Italy

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Lido di Camaiore, LU, Italy

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Milan, MI, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Trieste, TS, Italy

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Arcugnano, VI, Italy

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Cassino, , Italy

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Napoli, , Italy

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Napoli, , Italy

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Zwolle, AB, Netherlands

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Blaricum, AN, Netherlands

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Maastricht, AZ, Netherlands

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Breda, CK, Netherlands

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Enschede, ER, Netherlands

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Tilburg, GC, Netherlands

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Groningen, GZ, Netherlands

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's-Hertogenbosch, JL, Netherlands

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Heerlen, PC, Netherlands

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Sittard, , Netherlands

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Adana, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Sihhiye/Ankara, , Turkey (Türkiye)

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Yenisehir/Izmir, , Turkey (Türkiye)

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Blackburn, , United Kingdom

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Blandford Forum, Dorset, , United Kingdom

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Christchurch, Dorset, , United Kingdom

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Newcastle, , United Kingdom

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Oxford, , United Kingdom

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Peterborough, , United Kingdom

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Southampton, , United Kingdom

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Vale of Glamorgan, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Canada France Germany Italy Netherlands Spain Turkey (Türkiye) United Kingdom

Other Identifiers

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CENA713B2315

Identifier Type: -

Identifier Source: org_study_id