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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)

Primary Purpose

Parkinson's Disease Dementia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Rivastigmine capsule

Rivastigmine transdermal patch

About this trial

This is an interventional treatment trial for Parkinson's Disease Dementia focused on measuring Parkinson's disease dementia, cholinesterase inhibitor, rivastigmine

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Rivastigmine capsule

Rivastigmine patch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)

The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.

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)

The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.

Secondary Outcome Measures

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

Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.

Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline

Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention [0-37], Initiation/Perservation [0-37] (performing alternating movements), Construction [0-6] (copying designs), Conceptualization [0-39] (similarities) and Memory [0-25] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.

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

The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.

Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).

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

The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items. The change from baseline was calculated such that a positive change indicates an improvement.

UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)

Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).

Full Information

NCT ID

NCT00623103

First Posted

February 14, 2008

Last Updated

October 19, 2011

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00623103

Brief Title

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

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease Dementia

Keywords

Parkinson's disease dementia, cholinesterase inhibitor, rivastigmine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

583 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rivastigmine capsule

Arm Type

Experimental

Arm Description

Arm Title

Rivastigmine patch

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rivastigmine capsule

Other Intervention Name(s)

Exelon®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rivastigmine transdermal patch

Other Intervention Name(s)

Exelon®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)

Description

Time Frame

76 Weeks

Title

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)

Description

Time Frame

76 Weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline

Description

Time Frame

From Baseline to Weeks 16, 24, 52 and 76

Title

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

Description

Time Frame

From Baseline to Weeks 16, 24, 52 and 76

Title

Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

Description

Time Frame

At Week 16, 24, 52 and 76 (or early discontinuation)

Title

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

Description

Time Frame

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

Title

UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)

Description

Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).

Time Frame

From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

21st Century Neurology

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Neurosearch, Inc.

City

Reseda

State/Province

California

ZIP/Postal Code

91335

Country

United States

Facility Name

Neurosearch II, Inc.

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Sunrise Clinical Research, Inc.

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Collier Neurologic Specialists

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Comprehensive Neurology Specialists, PC

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Neurological Associates

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83646

Country

United States

Facility Name

Evanstan Northwestern Healthcare Medical Group

City

Glenview

State/Province

Illinois

ZIP/Postal Code

60026

Country

United States

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Neurological Care of Central NY

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210-1853

Country

United States

Facility Name

Neurology & Neuroscience Associates, Inc.

City

Akron

State/Province

Ohio

ZIP/Postal Code

44302

Country

United States

Facility Name

Square 1 Clinical Research

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16506

Country

United States

Facility Name

Research Protocol Management Solutions

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Neurology Specialists of Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Progressive Clinical Research

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

Veterans Affairs Puget Sound Health Care System

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

State/Province

Buenos Aires

ZIP/Postal Code

C1122AAL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

State/Province

Capital Federal

ZIP/Postal Code

C1429DUC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000BZL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1425CDC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Novartis Investigative Site

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Novartis Investigative Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative site

City

Linz

ZIP/Postal Code

A-4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1220

Country

Austria

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2018

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Jette

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N1

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 2B5

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3J 3T1

Country

Canada

Facility Name

Novartis Investigative Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2H 5Z8

Country

Canada

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 4G3

Country

Canada

Facility Name

Novartis Investigative site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Novartis Investigative Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Novartis Investigative Site

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 1A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1R 3X5

Country

Canada

Facility Name

Novartis Investigative Site

City

Amiens Cedex

ZIP/Postal Code

80054

Country

France

Facility Name

Novartis Investigative Site

City

Clermont

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille Cedex

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative site

City

Rennes

ZIP/Postal Code

F-35043

Country

France

Facility Name

Novartis Investigative Site

City

Roanne

ZIP/Postal Code

42328

Country

France

Facility Name

Novartis Investigative Site

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Novartis Investigative Site

City

Beelitz-Heilstaetten

ZIP/Postal Code

14547

Country

Germany

Facility Name

Novartis Investigative site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Goettingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

21075

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34128

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leun-Biskirchen

ZIP/Postal Code

35638

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebben

ZIP/Postal Code

15907

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

D-55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35032

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80804

Country

Germany

Facility Name

Novartis Investigative Site

City

Munchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90402

Country

Germany

Facility Name

Novartis Investigative site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Wolfach

ZIP/Postal Code

77709

Country

Germany

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70121

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Foggia

State/Province

ZIP/Postal Code

71100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pozzilli

State/Province

ZIP/Postal Code

86077

Country

Italy

Facility Name

Novartis Investigative Site

City

Lido di Camaiore

State/Province

ZIP/Postal Code

55041

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00163

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00179

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00185

Country

Italy

Facility Name

Novartis Investigative Site

City

Trieste

State/Province

ZIP/Postal Code

34149

Country

Italy

Facility Name

Novartis Investigative Site

City

Arcugnano

State/Province

ZIP/Postal Code

36057

Country

Italy

Facility Name

Novartis Investigative site

City

Cassino

ZIP/Postal Code

03043

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Novartis Investigative Site

City

Zwolle

State/Province

ZIP/Postal Code

8025

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Blaricum

State/Province

ZIP/Postal Code

1261

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Maastricht

State/Province

ZIP/Postal Code

6202

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

State/Province

ZIP/Postal Code

4818

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Enschede

State/Province

ZIP/Postal Code

7513

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Tilburg

State/Province

ZIP/Postal Code

5022

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

State/Province

ZIP/Postal Code

9713

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hertogenbosch

State/Province

ZIP/Postal Code

5232

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Heerlen

State/Province

ZIP/Postal Code

6419

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Sittard

ZIP/Postal Code

6131 BK

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08014

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08190

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Novartis Investigative Site

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novartis Investigative Site

City

Sihhiye/Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Yenisehir/Izmir

ZIP/Postal Code

35120

Country

Turkey

Facility Name

Novartis Investigative Site

City

Blackburn

ZIP/Postal Code

BB2 3HH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Blandford Forum, Dorset

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Christchurch, Dorset

ZIP/Postal Code

BH 232JX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle

ZIP/Postal Code

NE4 5PL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Peterborough

ZIP/Postal Code

PE3 6DA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO30 3JB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Vale of Glamorgan

ZIP/Postal Code

CF64 2XX

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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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)

Parkinson's Disease Dementia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial