CompletedPhase 3Results posted

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

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)

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

127

Recruiting sites

Enrollment

583

actual

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MMSE 10-26

Primary endpoints

•Adverse Events (AEs) Due, or Potentially Due•Study Drug Discontinuations Due to Predefined AEs That Are Due

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCENA713B2315

NCT IDNCT00623103

Timeline

Milestones

Study start2008-01 (month precision)

Study first posted2008-02-25estimated

Primary completion2010-11actual (month precision)

Last update posted2011-11-28estimated

Results first posted2011-11-28estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

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

Time frame:From Baseline to Weeks 16, 24, 52 and 76

change from baseline, improvement

Secondary/registry result

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

Time frame:From Baseline to Weeks 16, 24, 52 and 76

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
Rivastigmine CapsuleWeek 16n=273 Participants	5.4	11.98
Week 24n=273 Participants	6.5	12.98
Week 52n=273 Participants	4.6	13.62
Week 76n=273 Participants	3.9	16.82
Rivastigmine PatchWeek 16n=273 Participants	3.4	11.53
Week 24n=273 Participants	4.4	12.85
Week 52n=273 Participants	1.3	15.07
Week 76n=273 Participants	-1.4	17.43

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Score	Standard deviation
Rivastigmine CapsuleWeek 16 (n=273, 270)n=294 Participants	-0.4	9.60
Week 24 (n=273,270)n=294 Participants	-0.6	10.12
Week 52 (n=273,270)n=294 Participants	-2.2	11.13
Week 76 (n=273, 270)n=294 Participants	-4.4	13.13
Rivastigmine PatchWeek 16 (n=273, 270)n=288 Participants	-1.3	10.38
Week 24 (n=273,270)n=288 Participants	-1.5	10.91
Week 52 (n=273,270)n=288 Participants	-5.4	13.57
Week 76 (n=273, 270)n=288 Participants	-7.8	15.62

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

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

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

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

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

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

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Score	Standard deviation
Rivastigmine CapsuleWeek 16n=294 Participants	-3.3	9.75
Week 24n=294 Participants	-2.6	10.31
Week 52n=294 Participants	-1.7	11.40
Week 76n=294 Participants	-1.6	11.22
Rivastigmine PatchWeek 16n=288 Participants	-0.5	10.89
Week 24n=288 Participants	-1.0	10.27
Week 52n=288 Participants	-0.3	11.26
Week 76n=288 Participants	0.7	12.62

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

Time frame:76 Weeks

threshold achievement, event

Primary/registry result

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

Time frame:76 Weeks

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Rivastigmine CapsuleTremorn=294 Participants	24.5	-19.7 - 29.8
Muscle Rigidityn=294 Participants	4.1	-2.1 - 7.0
Bradykinesian=294 Participants	5.1	-2.9 - 8.3
Falln=294 Participants	17.0	-12.9 - 21.8
Rivastigmine PatchTremorn=288 Participants	9.7	-6.6 - 13.7
Muscle Rigidityn=288 Participants	5.2	-2.9 - 8.4
Bradykinesian=288 Participants	6.3	-3.7 - 9.7
Falln=288 Participants	20.1	-15.7 - 25.2

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

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)

Time frame:76 Weeks

threshold achievement, improvement

Primary/registry result

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)

Time frame:76 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Rivastigmine CapsuleTremorn=294 Participants	2.4	-1.0 - 4.8
Muscle Rigidityn=294 Participants	0.3	-0.0 - 1.9
Bradykinesian=294 Participants	1.0	-0.2 - 3.0
Falln=294 Participants	1.0	-0.2 - 3.0
Rivastigmine PatchTremorn=288 Participants	0.7	-0.1 - 2.5
Muscle Rigidityn=288 Participants	0.3	-0.0 - 1.9
Bradykinesian=288 Participants	0.0	-0.0 - 0.0
Falln=288 Participants	1.4	-0.4 - 3.5

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

Time frame:From Baseline to Weeks 8, 16, 24, 52 and 76

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:From Baseline to Weeks 16, 24, 52 and 76

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

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

ratio, descriptive

Secondary/registry result/low confidence

Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline

Time frame:From Baseline to Weeks 8, 16, 24, 52 and 76

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
Rivastigmine CapsuleWeek 8 (n=276,277)n=294 Participants	-0.4	6.99
Week 16 (n=254,252)n=294 Participants	0.5	7.72
Week 24 (n=229,237)n=294 Participants	0.1	8.19
Week 52 (n=203,206)n=294 Participants	0.7	8.66
Week 76 (n=183,175)n=294 Participants	2.1	9.98
Rivastigmine PatchWeek 8 (n=276,277)n=288 Participants	-0.9	7.05
Week 16 (n=254,252)n=288 Participants	-1.7	7.44
Week 24 (n=229,237)n=288 Participants	-1.4	7.90
Week 52 (n=203,206)n=288 Participants	1.6	9.57
Week 76 (n=183,175)n=288 Participants	2.1	9.65

Secondary/registry result/low confidence

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

Time frame:From Baseline to Weeks 16, 24, 52 and 76

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
Rivastigmine CapsuleWeek 16n=273 Participants	0.5	2.75
Week 24n=273 Participants	0.6	3.18
Week 52n=273 Participants	0.3	2.97
Week 76n=273 Participants	0.0	3.2
Rivastigmine PatchWeek 16n=273 Participants	0.4	3.02
Week 24n=273 Participants	0.3	3.40
Week 52n=273 Participants	-0.1	3.33
Week 76n=273 Participants	-0.3	3.57

Secondary/registry result/low confidence

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

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

ratio, descriptive

Posted result

Group	Value (mean), Score	Standard deviation
Rivastigmine CapsuleBaseline (n = 294,288)n=294 Participants	2.7	0.65
Week 8 (n=17,18)n=294 Participants	2.6	0.70
Week 16 (n=254,252)n=294 Participants	2.8	0.68
Week 24 (229, 236)n=294 Participants	2.7	0.75
Week 52 (n=202,208)n=294 Participants	2.8	0.73
Week 76 (n=184, 175)n=294 Participants	2.8	0.74
Rivastigmine PatchBaseline (n = 294,288)n=288 Participants	2.7	0.70
Week 8 (n=17,18)n=288 Participants	2.7	1.05
Week 16 (n=254,252)n=288 Participants	2.7	0.67
Week 24 (229, 236)n=288 Participants	2.7	0.67
Week 52 (n=202,208)n=288 Participants	2.8	0.69
Week 76 (n=184, 175)n=288 Participants	2.8	0.79

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.