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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)

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00623103
Collaborator
(none)
583
Enrollment
127
Locations
2
Arms
4.6
Patients Per Site

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rivastigmine capsule
  • Drug: Rivastigmine transdermal patch
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
583 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Nov 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Rivastigmine capsule
Rivastigmine capsules orally twice a day. Target dose 12 mg/day.
Other Names:
  • Exelon®

    		•
    Experimental: 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.

    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.
    Other Names:
  • Exelon®

    		•

    Outcome Measures

    Primary Outcome Measures

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

      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.

    2. 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) [76 Weeks]

      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

    1. 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 [From Baseline to Weeks 8, 16, 24, 52 and 76]

      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.

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

      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.

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

      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.

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

      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).

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

      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.

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 21st Century Neurology Phoenix Arizona United States 85004
    3 Neurosearch, Inc. Reseda California United States 91335
    4 Neurosearch II, Inc. Ventura California United States 93003
    5 Sunrise Clinical Research, Inc. Hollywood Florida United States 33021
    6 Collier Neurologic Specialists Naples Florida United States 34102
    7 Comprehensive Neurology Specialists, PC Suwanee Georgia United States 30024
    8 Neurological Associates Meridian Idaho United States 83646
    9 Evanstan Northwestern Healthcare Medical Group Glenview Illinois United States 60026
    10 University of Kansas Medical Center Kansas City Kansas United States 66160
    11 Neurological Care of Central NY Syracuse New York United States 13210-1853
    12 Neurology & Neuroscience Associates, Inc. Akron Ohio United States 44302
    13 Square 1 Clinical Research Erie Pennsylvania United States 16506
    14 Research Protocol Management Solutions Pittsburgh Pennsylvania United States 15243
    15 Neurology Specialists of Dallas Dallas Texas United States 75231
    16 Progressive Clinical Research Bountiful Utah United States 84010
    17 Veterans Affairs Puget Sound Health Care System Seattle Washington United States 98108
    18 Novartis Investigative Site Ciudad Autonoma de Bs As Buenos Aires Argentina C1122AAL
    19 Novartis Investigative Site Buenos Aires Capital Federal Argentina C1429DUC
    20 Novartis Investigative Site Rosario Santa Fe Argentina S2000BZL
    21 Novartis Investigative Site Buenos Aires Argentina C1425CDC
    22 Novartis Investigative Site Kogarah New South Wales Australia 2217
    23 Novartis Investigative Site Heidelberg Victoria Australia 3084
    24 Novartis Investigative Site Malvern Victoria Australia 3144
    25 Novartis Investigative Site Melbourne Victoria Australia 3050
    26 Novartis Investigative Site Prahran Victoria Australia 3181
    27 Novartis Investigative Site Graz Austria 8036
    28 Novartis Investigative Site Innsbruck Austria 6020
    29 Novartis Investigative Site Linz Austria 4020
    30 Novartis Investigative site Linz Austria A-4020
    31 Novartis Investigative Site Vienna Austria 1220
    32 Novartis Investigative Site Antwerpen Belgium 2018
    33 Novartis Investigative Site Bruxelles Belgium 1200
    34 Novartis Investigative Site Edegem Belgium 2650
    35 Novartis Investigative Site Jette Belgium 1090
    36 Novartis Investigative Site Kortrijk Belgium 8500
    37 Novartis Investigative Site Leuven Belgium 3000
    38 Novartis Investigative Site Liege Belgium 4000
    39 Novartis Investigative Site Wilrijk Belgium 2610
    40 Novartis Investigative Site Calgary Alberta Canada T2N 4N1
    41 Novartis Investigative Site Vancouver British Columbia Canada V6T 2B5
    42 Novartis Investigative Site Halifax Nova Scotia Canada B3J 3T1
    43 Novartis Investigative Site Kitchener Ontario Canada N2H 5Z8
    44 Novartis Investigative Site London Ontario Canada N6A 5A5
    45 Novartis Investigative Site Ottawa Ontario Canada K1G 4G3
    46 Novartis Investigative site Toronto Ontario Canada M4N 3M5
    47 Novartis Investigative Site Windsor Ontario Canada N8X 5A6
    48 Novartis Investigative Site Greenfield Park Quebec Canada J4V 2J2
    49 Novartis Investigative Site Montreal Quebec Canada H2L 4M1
    50 Novartis Investigative Site Montreal Quebec Canada H3G 1A4
    51 Novartis Investigative Site Regina Saskatchewan Canada S4T 1A5
    52 Novartis Investigative Site Quebec Canada G1R 3X5
    53 Novartis Investigative Site Amiens Cedex France 80054
    54 Novartis Investigative Site Clermont France 63003
    55 Novartis Investigative Site Lille Cedex France 59037
    56 Novartis Investigative Site Marseille Cedex France 13385
    57 Novartis Investigative Site Montpellier Cedex 5 France 34295
    58 Novartis Investigative Site Paris Cedex France 75651
    59 Novartis Investigative site Pessac Cedex France 33604
    60 Novartis Investigative site Rennes France F-35043
    61 Novartis Investigative Site Roanne France 42328
    62 Novartis Investigative Site Bad Nauheim Germany 61231
    63 Novartis Investigative Site Beelitz-Heilstaetten Germany 14547
    64 Novartis Investigative site Berlin Germany 10713
    65 Novartis Investigative Site Berlin Germany 13353
    66 Novartis Investigative Site Bonn Germany 53105
    67 Novartis Investigative Site Dresden Germany 01307
    68 Novartis Investigative Site Goettingen Germany 37075
    69 Novartis Investigative Site Hamburg Germany 21075
    70 Novartis Investigative Site Kassel Germany 34128
    71 Novartis Investigative Site Leipzig Germany 04103
    72 Novartis Investigative Site Leun-Biskirchen Germany 35638
    73 Novartis Investigative Site Luebben Germany 15907
    74 Novartis Investigative Site Mainz Germany D-55131
    75 Novartis Investigative Site Marburg Germany 35032
    76 Novartis Investigative Site Muenchen Germany 80804
    77 Novartis Investigative Site Munchen Germany 81675
    78 Novartis Investigative Site Nuernberg Germany 90402
    79 Novartis Investigative site Ulm Germany 89073
    80 Novartis Investigative Site Ulm Germany 89081
    81 Novartis Investigative Site Wolfach Germany 77709
    82 Novartis Investigative Site Bari BA Italy 70121
    83 Novartis Investigative Site Bologna BO Italy 40138
    84 Novartis Investigative Site Brescia BS Italy 25123
    85 Novartis Investigative Site Foggia FG Italy 71100
    86 Novartis Investigative Site Pozzilli IS Italy 86077
    87 Novartis Investigative Site Lido di Camaiore LU Italy 55041
    88 Novartis Investigative Site Milano MI Italy 20100
    89 Novartis Investigative Site Roma RM Italy 00133
    90 Novartis Investigative Site Roma RM Italy 00163
    91 Novartis Investigative Site Roma RM Italy 00179
    92 Novartis Investigative Site Roma RM Italy 00185
    93 Novartis Investigative Site Trieste TS Italy 34149
    94 Novartis Investigative Site Arcugnano VI Italy 36057
    95 Novartis Investigative site Cassino Italy 03043
    96 Novartis Investigative Site Napoli Italy 80131
    97 Novartis Investigative Site Napoli Italy 80138
    98 Novartis Investigative Site Zwolle AB Netherlands 8025
    99 Novartis Investigative Site Blaricum AN Netherlands 1261
    100 Novartis Investigative Site Maastricht AZ Netherlands 6202
    101 Novartis Investigative Site Breda CK Netherlands 4818
    102 Novartis Investigative Site Enschede ER Netherlands 7513
    103 Novartis Investigative Site Tilburg GC Netherlands 5022
    104 Novartis Investigative Site Groningen GZ Netherlands 9713
    105 Novartis Investigative Site Hertogenbosch JL Netherlands 5232
    106 Novartis Investigative Site Heerlen PC Netherlands 6419
    107 Novartis Investigative Site Sittard Netherlands 6131 BK
    108 Novartis Investigative Site Barcelona Spain 08014
    109 Novartis Investigative Site Barcelona Spain 08028
    110 Novartis Investigative Site Barcelona Spain 08035
    111 Novartis Investigative Site Barcelona Spain 08190
    112 Novartis Investigative Site Madrid Spain 28034
    113 Novartis Investigative Site Adana Turkey 01330
    114 Novartis Investigative Site Antalya Turkey 07059
    115 Novartis Investigative Site Istanbul Turkey 34093
    116 Novartis Investigative Site Izmir Turkey 35340
    117 Novartis Investigative Site Kocaeli Turkey 41380
    118 Novartis Investigative Site Sihhiye/Ankara Turkey 06100
    119 Novartis Investigative Site Yenisehir/Izmir Turkey 35120
    120 Novartis Investigative Site Blackburn United Kingdom BB2 3HH
    121 Novartis Investigative Site Blandford Forum, Dorset United Kingdom
    122 Novartis Investigative Site Christchurch, Dorset United Kingdom BH 232JX
    123 Novartis Investigative Site Newcastle United Kingdom NE4 5PL
    124 Novartis Investigative Site Oxford United Kingdom OX3 9DU
    125 Novartis Investigative Site Peterborough United Kingdom PE3 6DA
    126 Novartis Investigative Site Southampton United Kingdom SO30 3JB
    127 Novartis Investigative Site Vale of Glamorgan United Kingdom CF64 2XX

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis
    ClinicalTrials.gov Identifier:
    NCT00623103
    Other Study ID Numbers:
    • CENA713B2315
    First Posted:
    Feb 25, 2008
    Last Update Posted:
    Nov 28, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Novartis
    Parkinson's disease dementia
    cholinesterase inhibitor
    rivastigmine
    Additional relevant MeSH terms:
    Parkinson Disease
    Dementia
    Rivastigmine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Period Title: Overall Study
    STARTED 295 288
    Safety Set: Received Study Drug 294 288
    COMPLETED 184 175
    NOT COMPLETED 111 113

    Baseline Characteristics

    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch Total
    Arm/Group 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 orally0. 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. Total of all reporting groups
    Overall Participants 295 288 583
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    72.35
    (6.295)
    72.26
    (6.352)
    72.31
    (6.318)
    Sex: Female, Male (Count of Participants)
    Female
    88
    29.8%
    97
    33.7%
    185
    31.7%
    Male
    207
    70.2%
    191
    66.3%
    398
    68.3%

    Outcome Measures

    1. Primary Outcome
    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 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.
    Time Frame 76 Weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 294 288
    Tremor
    24.5
    8.3%
    9.7
    3.4%
    Muscle Rigidity
    4.1
    1.4%
    5.2
    1.8%
    Bradykinesia
    5.1
    1.7%
    6.3
    2.2%
    Fall
    17.0
    5.8%
    20.1
    7%
    2. Primary Outcome
    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 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.
    Time Frame 76 Weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 294 288
    Tremor
    2.4
    0.8%
    0.7
    0.2%
    Muscle Rigidity
    0.3
    0.1%
    0.3
    0.1%
    Bradykinesia
    1.0
    0.3%
    0.0
    0%
    Fall
    1.0
    0.3%
    1.4
    0.5%
    3. Secondary Outcome
    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 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.
    Time Frame From Baseline to Weeks 8, 16, 24, 52 and 76

    Outcome Measure Data

    Analysis Population Description
    Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. "n" in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements.
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 294 288
    Week 8 (n=276,277)
    -0.4
    (6.99)
    -0.9
    (7.05)
    Week 16 (n=254,252)
    0.5
    (7.72)
    -1.7
    (7.44)
    Week 24 (n=229,237)
    0.1
    (8.19)
    -1.4
    (7.90)
    Week 52 (n=203,206)
    0.7
    (8.66)
    1.6
    (9.57)
    Week 76 (n=183,175)
    2.1
    (9.98)
    2.1
    (9.65)
    4. Secondary Outcome
    Title Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline
    Description 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.
    Time Frame From Baseline to Weeks 16, 24, 52 and 76

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 273 273
    Week 16
    5.4
    (11.98)
    3.4
    (11.53)
    Week 24
    6.5
    (12.98)
    4.4
    (12.85)
    Week 52
    4.6
    (13.62)
    1.3
    (15.07)
    Week 76
    3.9
    (16.82)
    -1.4
    (17.43)
    5. Secondary Outcome
    Title Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
    Description 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.
    Time Frame From Baseline to Weeks 16, 24, 52 and 76

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 273 273
    Week 16
    0.5
    (2.75)
    0.4
    (3.02)
    Week 24
    0.6
    (3.18)
    0.3
    (3.40)
    Week 52
    0.3
    (2.97)
    -0.1
    (3.33)
    Week 76
    0.0
    (3.2)
    -0.3
    (3.57)
    6. Secondary Outcome
    Title Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline
    Description 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).
    Time Frame At Week 16, 24, 52 and 76 (or early discontinuation)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 294 288
    Week 16
    -3.3
    (9.75)
    -0.5
    (10.89)
    Week 24
    -2.6
    (10.31)
    -1.0
    (10.27)
    Week 52
    -1.7
    (11.40)
    -0.3
    (11.26)
    Week 76
    -1.6
    (11.22)
    0.7
    (12.62)
    7. Secondary Outcome
    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 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.
    Time Frame From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF).
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 294 288
    Week 16 (n=273, 270)
    -0.4
    (9.60)
    -1.3
    (10.38)
    Week 24 (n=273,270)
    -0.6
    (10.12)
    -1.5
    (10.91)
    Week 52 (n=273,270)
    -2.2
    (11.13)
    -5.4
    (13.57)
    Week 76 (n=273, 270)
    -4.4
    (13.13)
    -7.8
    (15.62)
    8. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints.
    Arm/Group Title Rivastigmine Capsule Rivastigmine Patch
    Arm/Group 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 orally0. 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.
    Measure Participants 294 288
    Baseline (n = 294,288)
    2.7
    (0.65)
    2.7
    (0.70)
    Week 8 (n=17,18)
    2.6
    (0.70)
    2.7
    (1.05)
    Week 16 (n=254,252)
    2.8
    (0.68)
    2.7
    (0.67)
    Week 24 (229, 236)
    2.7
    (0.75)
    2.7
    (0.67)
    Week 52 (n=202,208)
    2.8
    (0.73)
    2.8
    (0.69)
    Week 76 (n=184, 175)
    2.8
    (0.74)
    2.8
    (0.79)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Exelon Capsule Exelon Patch
    Arm/Group Description Exelon Capsule Exelon Patch
    All Cause Mortality
    Exelon Capsule Exelon Patch
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Exelon Capsule Exelon Patch
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 87/294 (29.6%) 83/288 (28.8%)
    Cardiac disorders
    Acute myocardial infarction 0/294 (0%) 1/288 (0.3%)
    Angina pectoris 1/294 (0.3%) 2/288 (0.7%)
    Arteriosclerosis coronary artery 1/294 (0.3%) 0/288 (0%)
    Atrial fibrillation 3/294 (1%) 0/288 (0%)
    Atrial flutter 1/294 (0.3%) 0/288 (0%)
    Atrioventricular block second degree 0/294 (0%) 1/288 (0.3%)
    Bradycardia 1/294 (0.3%) 0/288 (0%)
    Cardiac arrest 1/294 (0.3%) 0/288 (0%)
    Cardiac failure 1/294 (0.3%) 2/288 (0.7%)
    Cardiac failure acute 0/294 (0%) 1/288 (0.3%)
    Cardiac valve sclerosis 1/294 (0.3%) 0/288 (0%)
    Cardio-respiratory arrest 1/294 (0.3%) 1/288 (0.3%)
    Coronary artery disease 1/294 (0.3%) 1/288 (0.3%)
    Myocardial infarction 2/294 (0.7%) 2/288 (0.7%)
    Sinus arrhythmia 1/294 (0.3%) 0/288 (0%)
    Gastrointestinal disorders
    Abdominal distension 1/294 (0.3%) 0/288 (0%)
    Abdominal hernia 1/294 (0.3%) 0/288 (0%)
    Abdominal pain 1/294 (0.3%) 0/288 (0%)
    Abdominal pain upper 1/294 (0.3%) 0/288 (0%)
    Constipation 0/294 (0%) 1/288 (0.3%)
    Diarrhoea 1/294 (0.3%) 3/288 (1%)
    Duodenal ulcer haemorrhage 1/294 (0.3%) 0/288 (0%)
    Gastric ulcer haemorrhage 0/294 (0%) 1/288 (0.3%)
    Haemorrhoidal haemorrhage 0/294 (0%) 1/288 (0.3%)
    Haemorrhoids 0/294 (0%) 1/288 (0.3%)
    Ileus 1/294 (0.3%) 1/288 (0.3%)
    Inguinal hernia 1/294 (0.3%) 1/288 (0.3%)
    Inguinal hernia strangulated 1/294 (0.3%) 0/288 (0%)
    Intestinal obstruction 1/294 (0.3%) 1/288 (0.3%)
    Melaena 0/294 (0%) 1/288 (0.3%)
    Mesenteric occlusion 1/294 (0.3%) 1/288 (0.3%)
    Nausea 2/294 (0.7%) 1/288 (0.3%)
    Pancreatitis 1/294 (0.3%) 0/288 (0%)
    Pancreatitis acute 1/294 (0.3%) 0/288 (0%)
    Periodontitis 0/294 (0%) 1/288 (0.3%)
    Rectal haemorrhage 0/294 (0%) 1/288 (0.3%)
    Salivary hypersecretion 1/294 (0.3%) 0/288 (0%)
    Small intestinal obstruction 2/294 (0.7%) 0/288 (0%)
    Umbilical hernia 1/294 (0.3%) 0/288 (0%)
    Vomiting 0/294 (0%) 1/288 (0.3%)
    General disorders
    Asthenia 1/294 (0.3%) 0/288 (0%)
    Complication of device insertion 0/294 (0%) 1/288 (0.3%)
    Device failure 1/294 (0.3%) 0/288 (0%)
    Fatigue 2/294 (0.7%) 0/288 (0%)
    Gait disturbance 0/294 (0%) 1/288 (0.3%)
    General physical health deterioration 1/294 (0.3%) 0/288 (0%)
    Non-cardiac chest pain 2/294 (0.7%) 0/288 (0%)
    Pyrexia 2/294 (0.7%) 3/288 (1%)
    Hepatobiliary disorders
    Cholelithiasis 2/294 (0.7%) 1/288 (0.3%)
    Infections and infestations
    Bronchitis 1/294 (0.3%) 0/288 (0%)
    Bronchopneumonia 1/294 (0.3%) 1/288 (0.3%)
    Cellulitis 0/294 (0%) 1/288 (0.3%)
    Cystitis klebsiella 1/294 (0.3%) 0/288 (0%)
    Gastroenteritis viral 0/294 (0%) 1/288 (0.3%)
    Gastrointestinal infection 2/294 (0.7%) 0/288 (0%)
    Helicobacter infection 2/294 (0.7%) 0/288 (0%)
    Lung infection 1/294 (0.3%) 0/288 (0%)
    Pneumonia 9/294 (3.1%) 7/288 (2.4%)
    Pneumonia fungal 1/294 (0.3%) 0/288 (0%)
    Post procedural sepsis 0/294 (0%) 1/288 (0.3%)
    Rash pustular 1/294 (0.3%) 0/288 (0%)
    Respiratory tract infection 2/294 (0.7%) 0/288 (0%)
    Sepsis 0/294 (0%) 1/288 (0.3%)
    Tracheobronchitis 0/294 (0%) 1/288 (0.3%)
    Urinary tract infection 2/294 (0.7%) 4/288 (1.4%)
    Injury, poisoning and procedural complications
    Accidental overdose 0/294 (0%) 1/288 (0.3%)
    Brain herniation 1/294 (0.3%) 0/288 (0%)
    Concussion 1/294 (0.3%) 0/288 (0%)
    Contusion 2/294 (0.7%) 0/288 (0%)
    Fall 2/294 (0.7%) 9/288 (3.1%)
    Femoral neck fracture 2/294 (0.7%) 1/288 (0.3%)
    Femur fracture 6/294 (2%) 3/288 (1%)
    Hand fracture 1/294 (0.3%) 0/288 (0%)
    Head injury 2/294 (0.7%) 0/288 (0%)
    Hip fracture 3/294 (1%) 2/288 (0.7%)
    Humerus fracture 0/294 (0%) 2/288 (0.7%)
    Lower limb fracture 1/294 (0.3%) 2/288 (0.7%)
    Nerve root injury 0/294 (0%) 1/288 (0.3%)
    Pelvic fracture 0/294 (0%) 1/288 (0.3%)
    Post-traumatic pain 1/294 (0.3%) 0/288 (0%)
    Rib fracture 1/294 (0.3%) 2/288 (0.7%)
    Scapula fracture 1/294 (0.3%) 0/288 (0%)
    Skin laceration 1/294 (0.3%) 0/288 (0%)
    Spinal compression fracture 1/294 (0.3%) 0/288 (0%)
    Spinal fracture 1/294 (0.3%) 0/288 (0%)
    Upper limb fracture 1/294 (0.3%) 0/288 (0%)
    Wrist fracture 1/294 (0.3%) 0/288 (0%)
    Investigations
    Weight decreased 0/294 (0%) 1/288 (0.3%)
    Metabolism and nutrition disorders
    Decreased appetite 0/294 (0%) 1/288 (0.3%)
    Dehydration 3/294 (1%) 4/288 (1.4%)
    Hypokalaemia 1/294 (0.3%) 0/288 (0%)
    Weight loss poor 0/294 (0%) 1/288 (0.3%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/294 (0%) 1/288 (0.3%)
    Back pain 2/294 (0.7%) 0/288 (0%)
    Bursitis 1/294 (0.3%) 0/288 (0%)
    Mobility decreased 0/294 (0%) 1/288 (0.3%)
    Musculoskeletal discomfort 0/294 (0%) 1/288 (0.3%)
    Pathological fracture 1/294 (0.3%) 0/288 (0%)
    Spinal osteoarthritis 0/294 (0%) 1/288 (0.3%)
    Synovitis 1/294 (0.3%) 0/288 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 1/294 (0.3%) 0/288 (0%)
    Breast cancer 0/294 (0%) 1/288 (0.3%)
    Malignant melanoma 1/294 (0.3%) 0/288 (0%)
    Meningioma benign 0/294 (0%) 1/288 (0.3%)
    Prostate cancer 1/294 (0.3%) 1/288 (0.3%)
    Rectosigmoid cancer 0/294 (0%) 1/288 (0.3%)
    Waldenstrom's macroglobulinaemia 0/294 (0%) 1/288 (0.3%)
    Nervous system disorders
    Akinesia 2/294 (0.7%) 3/288 (1%)
    Aphasia 0/294 (0%) 1/288 (0.3%)
    Balance disorder 1/294 (0.3%) 0/288 (0%)
    Basilar artery thrombosis 0/294 (0%) 1/288 (0.3%)
    Bradykinesia 2/294 (0.7%) 3/288 (1%)
    Cerebral infarction 0/294 (0%) 2/288 (0.7%)
    Cerebrovascular accident 1/294 (0.3%) 0/288 (0%)
    Cognitive disorder 1/294 (0.3%) 0/288 (0%)
    Cogwheel rigidity 4/294 (1.4%) 2/288 (0.7%)
    Coma 0/294 (0%) 1/288 (0.3%)
    Convulsion 0/294 (0%) 1/288 (0.3%)
    Dementia 1/294 (0.3%) 0/288 (0%)
    Depressed level of consciousness 1/294 (0.3%) 0/288 (0%)
    Dizziness 1/294 (0.3%) 3/288 (1%)
    Dysarthria 0/294 (0%) 1/288 (0.3%)
    Dyskinesia 0/294 (0%) 3/288 (1%)
    Epilepsy 0/294 (0%) 2/288 (0.7%)
    Freezing phenomenon 2/294 (0.7%) 1/288 (0.3%)
    Hypokinesia 0/294 (0%) 1/288 (0.3%)
    Lacunar infarction 0/294 (0%) 1/288 (0.3%)
    Loss of consciousness 1/294 (0.3%) 2/288 (0.7%)
    Monoparesis 0/294 (0%) 1/288 (0.3%)
    On and off phenomenon 3/294 (1%) 0/288 (0%)
    Parkinson's disease 0/294 (0%) 1/288 (0.3%)
    Parkinsonian gait 3/294 (1%) 2/288 (0.7%)
    Parkinsonian rest tremor 3/294 (1%) 2/288 (0.7%)
    Psychomotor hyperactivity 2/294 (0.7%) 0/288 (0%)
    Psychomotor skills impaired 1/294 (0.3%) 0/288 (0%)
    Quadriplegia 1/294 (0.3%) 0/288 (0%)
    Somnolence 1/294 (0.3%) 1/288 (0.3%)
    Syncope 5/294 (1.7%) 1/288 (0.3%)
    Transient ischaemic attack 1/294 (0.3%) 4/288 (1.4%)
    Psychiatric disorders
    Agitation 0/294 (0%) 2/288 (0.7%)
    Anxiety 1/294 (0.3%) 1/288 (0.3%)
    Confusional state 3/294 (1%) 6/288 (2.1%)
    Delirium 0/294 (0%) 2/288 (0.7%)
    Delusion 1/294 (0.3%) 1/288 (0.3%)
    Depression 0/294 (0%) 1/288 (0.3%)
    Hallucination 1/294 (0.3%) 4/288 (1.4%)
    Hallucination, visual 3/294 (1%) 3/288 (1%)
    Insomnia 0/294 (0%) 2/288 (0.7%)
    Mental status changes 1/294 (0.3%) 0/288 (0%)
    Psychotic disorder 0/294 (0%) 1/288 (0.3%)
    Psychotic disorder due to a general medical condition 0/294 (0%) 1/288 (0.3%)
    Renal and urinary disorders
    Bladder trabeculation 0/294 (0%) 1/288 (0.3%)
    Calculus bladder 1/294 (0.3%) 0/288 (0%)
    Haematuria 1/294 (0.3%) 0/288 (0%)
    Micturition urgency 0/294 (0%) 1/288 (0.3%)
    Renal failure 1/294 (0.3%) 1/288 (0.3%)
    Urinary bladder polyp 1/294 (0.3%) 0/288 (0%)
    Urinary incontinence 0/294 (0%) 1/288 (0.3%)
    Urinary retention 2/294 (0.7%) 0/288 (0%)
    Urinary tract obstruction 1/294 (0.3%) 0/288 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/294 (0.3%) 0/288 (0%)
    Prostatic obstruction 0/294 (0%) 1/288 (0.3%)
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/294 (0.3%) 0/288 (0%)
    Brain hypoxia 1/294 (0.3%) 1/288 (0.3%)
    Dyspnoea 3/294 (1%) 1/288 (0.3%)
    Lung disorder 0/294 (0%) 1/288 (0.3%)
    Pleural effusion 1/294 (0.3%) 0/288 (0%)
    Pneumonia aspiration 0/294 (0%) 1/288 (0.3%)
    Productive cough 0/294 (0%) 1/288 (0.3%)
    Pulmonary embolism 4/294 (1.4%) 1/288 (0.3%)
    Pulmonary oedema 1/294 (0.3%) 0/288 (0%)
    Respiratory arrest 1/294 (0.3%) 0/288 (0%)
    Skin and subcutaneous tissue disorders
    Skin ulcer 0/294 (0%) 1/288 (0.3%)
    Urticaria 1/294 (0.3%) 0/288 (0%)
    Vascular disorders
    Haematoma 0/294 (0%) 1/288 (0.3%)
    Hypertension 0/294 (0%) 2/288 (0.7%)
    Hypertensive crisis 1/294 (0.3%) 1/288 (0.3%)
    Hypotension 3/294 (1%) 0/288 (0%)
    Orthostatic hypotension 1/294 (0.3%) 0/288 (0%)
    Peripheral arterial occlusive disease 0/294 (0%) 1/288 (0.3%)
    Phlebitis 1/294 (0.3%) 0/288 (0%)
    Other (Not Including Serious) Adverse Events
    Exelon Capsule Exelon Patch
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 239/294 (81.3%) 215/288 (74.7%)
    Gastrointestinal disorders
    Constipation 21/294 (7.1%) 21/288 (7.3%)
    Diarrhoea 27/294 (9.2%) 14/288 (4.9%)
    Nausea 117/294 (39.8%) 23/288 (8%)
    Vomiting 45/294 (15.3%) 7/288 (2.4%)
    General disorders
    Application site erythema 0/294 (0%) 40/288 (13.9%)
    Fatigue 19/294 (6.5%) 13/288 (4.5%)
    Infections and infestations
    Urinary tract infection 17/294 (5.8%) 21/288 (7.3%)
    Injury, poisoning and procedural complications
    Fall 48/294 (16.3%) 49/288 (17%)
    Investigations
    Weight decreased 19/294 (6.5%) 18/288 (6.3%)
    Metabolism and nutrition disorders
    Decreased appetite 18/294 (6.1%) 12/288 (4.2%)
    Musculoskeletal and connective tissue disorders
    Back pain 13/294 (4.4%) 16/288 (5.6%)
    Nervous system disorders
    Bradykinesia 13/294 (4.4%) 15/288 (5.2%)
    Dizziness 26/294 (8.8%) 21/288 (7.3%)
    Headache 15/294 (5.1%) 12/288 (4.2%)
    On and off phenomenon 12/294 (4.1%) 16/288 (5.6%)
    Parkinsonian gait 15/294 (5.1%) 12/288 (4.2%)
    Parkinsonian rest tremor 69/294 (23.5%) 26/288 (9%)
    Somnolence 23/294 (7.8%) 18/288 (6.3%)
    Psychiatric disorders
    Anxiety 17/294 (5.8%) 22/288 (7.6%)
    Confusional state 21/294 (7.1%) 21/288 (7.3%)
    Depression 6/294 (2%) 22/288 (7.6%)
    Hallucination 19/294 (6.5%) 21/288 (7.3%)
    Hallucination, visual 12/294 (4.1%) 16/288 (5.6%)
    Insomnia 14/294 (4.8%) 23/288 (8%)
    Vascular disorders
    Hypertension 16/294 (5.4%) 12/288 (4.2%)
    Hypotension 22/294 (7.5%) 10/288 (3.5%)
    Orthostatic hypotension 18/294 (6.1%) 17/288 (5.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

    Results Point of Contact

    Name/Title Study Director
    Organization Novartis Pharmaceuticals
    Phone 862-778-8300
    Email
    Responsible Party:
    Novartis
    ClinicalTrials.gov Identifier:
    NCT00623103
    Other Study ID Numbers:
    • CENA713B2315
    First Posted:
    Feb 25, 2008
    Last Update Posted:
    Nov 28, 2011
    Last Verified:
    Oct 1, 2011