CompletedPhase 3Results posted

Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm^2 Patch in Patients With Mild to Moderate Alzheimer's Disease (AD) Showing Functional and Cognitive Decline

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

145

Recruiting sites

Enrollment

1,584

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE 10-24

Primary endpoints

•ADAS-Cog•Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living

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 IDCENA713D2340

NCT IDNCT00506415

Timeline

Milestones

Study start2007-06 (month precision)

Study first posted2007-07-25estimated

Primary completion2011-05actual (month precision)

Study completion2011-05actual (month precision)

Last update posted2012-09-19estimated

Results first posted2012-09-19estimated

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

•Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers Disease,

•Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,

•A primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments.

•For double blind only: Meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State Examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48

Exclusion criteria

•Presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk,

•Any medical or neurological condition other than Alzheimers Disease that could explain the patient's dementia,

•A diagnosis of probable or possible vascular dementia,

•A current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication,

•A history or current diagnosis of cerebrovascular disease (e.g. stroke),

•A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease).

Other protocol-defined inclusion/exclusion criteria may apply.

Endpoints (14)

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

Executive function / language

Function / daily living

Global cognition

Behavior / neuropsychiatric

Safety / tolerability / PK

Global cognition

2 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Double Blind: Rivastigmine (10 cm^2)n=268 Participants	4.9	7.49
Double Blind: Rivastigmine (15 cm^2)n=264 Participants	4.1	8.00

Executive function / language

4 endpoints

Secondary/protocol endpoint

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period

Time frame:Baseline and week 48 of double blind period

change from baseline, improvement

Secondary/protocol endpoint

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

change from baseline, improvement

Secondary/registry result

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period

Time frame:Baseline and week 48 of double blind period

change from baseline, improvement

Posted result

Group	Value (mean), Time in seconds	Standard deviation
Double Blind: Rivastigmine (10 cm^2)n=258 Participants	18.2	62.57
Double Blind: Rivastigmine (15 cm^2)n=254 Participants	16.3	66.09

Secondary/registry result

Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

change from baseline, improvement

Posted result

Group	Value (mean), Time in seconds	Standard deviation
Double Blind: Rivastigmine (15 cm^2)n=235 Participants	9.3	68.80
Double Blind: Rivastigmine (10 cm^2)n=236 Participants	5.8	65.38

Function / daily living

4 endpoints

Primary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

change from baseline, improvement

Primary/registry result

Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Double Blind: Rivastigmine (10 cm^2)n=271 Participants	-6.2	8.78
Double Blind: Rivastigmine (15 cm^2)n=265 Participants	-4.4	8.21

Secondary/protocol endpoint

Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period

Time frame:390 days was the maximum

time to event, event

Secondary/registry result

Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period

Time frame:390 days was the maximum

time to event, event

Posted result

Group	Value (median), Time in days	Reported bounds
Double Blind: Rivastigmine (10 cm^2)n=271 Participants	90	-85 - 113
Double Blind: Rivastigmine (15 cm^2)n=265 Participants	91	-85 - 113

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period

Time frame:Baseline and week 48 of double blind period

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Double Blind: Rivastigmine (10 cm^2)n=271 Participants	0.9	10.98
Double Blind: Rivastigmine (15 cm^2)n=265 Participants	1.4	11.51

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events

Time frame:30 days after a maximum of 96 weeks treatment

event count, event

Secondary/registry result

Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events

Time frame:30 days after a maximum of 96 weeks treatment

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)n=1582 Participants	1135	-
Double Blind: Rivastigmine (10 cm^2)n=283 Participants	193	-
Double Blind: Rivastigmine (15 cm^2)n=280 Participants	210	-
Extended Open Label (10 cm^2)n=457 Participants	263	-

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.