CompletedPhase 3Results posted

Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

A 24-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Evaluation of the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease (MMSE 10-20)

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

859

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10

Primary endpoints

•The Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)•Overall Clinical Rating of Change

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 IDCENA713D1301

SecondaryCENA713D1301E1

NCT IDNCT00423085

Timeline

Milestones

Study start2007-01 (month precision)

Study first posted2007-01-17estimated

Primary completion2009-03actual (month precision)

Study completion2010-04actual (month precision)

Results first posted2011-05-25estimated

Last update posted2014-02-10estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria

•A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria

•An MMSE score of > or = 10 and < or = 20

Exclusion criteria

•A current DSM-IV diagnosis of major depression

•Taken rivastigmine in the past

•A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS) Other protocol-defined inclusion/exclusion criteria may apply

Other protocol-defined inclusion/exclusion criteria may apply

Extension Phase Eligibility Criteria

Inclusion Criteria:

•Patients who have completed the Double-blind Treatment Phase on study medication

Exclusion Criteria

•Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase

Endpoints (18)

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

Function / daily living

Global cognition

Behavior / neuropsychiatric

Other clinical outcomes

Global cognition

6 endpoints

Primary/protocol endpoint

Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)

Time frame:Baseline and Week 24

change from baseline, improvement

Primary/registry result

Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PlaceboBaseline Scoren=265 Participants	24.8	9.46
Week 24 Scoren=265 Participants	26.1	11.49
Change from Baselinen=265 Participants	1.3	5.07
Rivastigmine 5 cm^2Baseline Scoren=266 Participants	25.2	9.62
Week 24 Scoren=266 Participants	25.7	11.70
Change from Baselinen=266 Participants	0.5	4.96
Rivastigmine 10 cm^2Baseline Scoren=268 Participants	25.0	9.93
Week 24 Scoren=268 Participants	25.1	11.25
Change from Baselinen=268 Participants	0.1	5.04

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)

Time frame:Extension Phase Baseline and Week 52 of extension phase

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PlaceboBaseline Scoren=251 Participants	16.7	2.87
Week 24 Scoren=251 Participants	16.4	4.21
Change from Baselinen=251 Participants	-0.3	2.82
Rivastigmine 5 cm^2Baseline Scoren=236 Participants	16.9	2.88
Week 24 Scoren=236 Participants	16.6	4.62
Change from Baselinen=236 Participants	-0.3	3.05
Rivastigmine 10 cm^2Baseline Scoren=246 Participants	16.4	3.09
Week 24 Scoren=246 Participants	16.4	4.47
Change from Baselinen=246 Participants	0.0	2.87

Secondary/registry result

Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)

Time frame:Extension Phase Baseline and Week 52 of extension phase

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Open-label Extension ArmExtension Baselinen=577 Participants	16.6	4.43
End of Extensionn=577 Participants	14.9	5.58
Change from Baselinen=577 Participants	-1.7	3.28

Function / daily living

8 endpoints

Primary/protocol endpoint

Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)

Time frame:Baseline and Week 24

change from baseline, improvement

Primary/registry result

Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
PlaceboMarkedly improvedn=267 Participants	0	-
Moderately improvedn=267 Participants	5	-
Minimally improvedn=267 Participants	36	-
Unchangedn=267 Participants	111	-
Minimally worsen=267 Participants	84	-
Moderately worsen=267 Participants	29	-
Markedly worsen=267 Participants	2	-
Rivastigmine 5 cm^2Markedly improvedn=269 Participants	0	-
Moderately improvedn=269 Participants	12	-
Minimally improvedn=269 Participants	45	-
Unchangedn=269 Participants	109	-
Minimally worsen=269 Participants	82	-
Moderately worsen=269 Participants	21	-
Markedly worsen=269 Participants	0	-
Rivastigmine 10 cm^2Markedly improvedn=270 Participants	0	-
Moderately improvedn=270 Participants	6	-
Minimally improvedn=270 Participants	53	-
Unchangedn=270 Participants	109	-
Minimally worsen=270 Participants	78	-
Moderately worsen=270 Participants	22	-
Markedly worsen=270 Participants	2	-

Secondary/protocol endpoint

Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/protocol endpoint

Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)

Time frame:Extension Phase Baseline and Week 52 of extension phase

descriptive

Secondary/protocol endpoint

Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale

Time frame:Extension Phase Baseline and Week 52 of extension phase

descriptive

Secondary/registry result

Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PlaceboBaseline Scoren=267 Participants	66.70	19.902
Week 24 Scoren=267 Participants	62.54	22.395
Change from Baselinen=267 Participants	-4.16	12.443
Rivastigmine 5 cm^2Baseline Scoren=269 Participants	64.19	20.571
Week 24 Scoren=269 Participants	61.19	22.415
Change from Baselinen=269 Participants	-2.99	10.259
Rivastigmine 10 cm^2Baseline Scoren=269 Participants	64.15	21.921
Week 24 Scoren=269 Participants	62.27	23.691
Change from Baselinen=269 Participants	-1.88	10.657

Secondary/registry result

Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)

Time frame:Extension Phase Baseline and Week 52 of extension phase

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Open-label Extension ArmExtension Baselinen=567 Participants	61.99	22.939
End of Extensionn=567 Participants	51.95	25.407
Change from Baselinen=567 Participants	-10.04	14.089

Secondary/registry result

Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale

Time frame:Extension Phase Baseline and Week 52 of extension phase

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
Open-label Extension ArmExtension Baselinen=634 Participants	20.0	10.04
End of Extensionn=634 Participants	24.0	11.30
Change from Baselinen=634 Participants	4.0	6.74

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PlaceboBaseline Scoren=267 Participants	4.8	4.50
Week 24 Scoren=267 Participants	4.8	5.41
Change from Baselinen=267 Participants	-0.1	3.76
Rivastigmine 5 cm^2Baseline Scoren=269 Participants	4.7	4.96
Week 24 Scoren=269 Participants	4.6	5.03
Change from Baselinen=269 Participants	-0.1	4.17
Rivastigmine 10 cm^2Baseline Scoren=270 Participants	5.4	5.15
Week 24 Scoren=270 Participants	5.1	5.89
Change from Baselinen=270 Participants	-0.3	4.70

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)

Time frame:Baseline and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PlaceboBaseline Scoren=267 Participants	23.2	11.13
Week 24 Scoren=267 Participants	26.1	12.68
Change from Baselinen=267 Participants	2.9	6.18
Rivastigmine 5 cm^2Baseline Scoren=269 Participants	24.3	11.72
Week 24 Scoren=269 Participants	26.5	13.43
Change from Baselinen=269 Participants	2.2	5.86
Rivastigmine 10 cm^2Baseline Scoren=270 Participants	24.6	11.36
Week 24 Scoren=270 Participants	26.2	12.69
Change from Baselinen=270 Participants	1.6	5.82

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.