CompletedPhase 3Results posted

A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease

A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Study to Assess the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (Mini-Mental State Examination (MMSE) 10-20)

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

501

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-20•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

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 IDCENA713D2344

NCT IDNCT01399125

Timeline

Milestones

Study start2011-07 (month precision)

Study first posted2011-07-21estimated

Primary completion2013-05actual (month precision)

Study completion2013-05actual (month precision)

Last update posted2014-08-04estimated

Results first posted2014-08-04estimated

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

•have a diagnosis of dementia of the Alzheimer's type according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria;

•have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria.

•have a brain scan (magnetic resonance imaging (MRI) or computed tomography (CT)) consistent with the diagnosis of AD. The brain scan must have been performed within one year prior to randomization;

•have an MMSE score of ≥ 10 and ≤ 20;

•have sufficient education to have been able to read, write, and communicate effectively during the premorbid state;

•be residing with someone in the community throughout the study or, if living alone, in contact with the primary caregiver everyday

Exclusion criteria

•have an advanced, severe, progressive, or unstable infectious, metabolic, immune, endocrinologic, hepatic, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological condition that may interfere with efficacy and safety assessments or put the patient at special risk;

•have a history or current diagnosis of any medical or neurological condition other than AD that is identified as contributing cause of the patient's dementia;

•have a current diagnosis of probable or possible vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences criteria (NINDS-AIREN);

•have a score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);

•have a current DSM-IV diagnosis of major depression, unless, in the opinion of the investigator, is in remission for at least 12 weeks;

Other protocol-defined inclusion/exclusion criteria may apply

Endpoints (10)

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

Global cognition

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

4 endpoints

Primary/protocol endpoint

Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)

Time frame:Change at 24 weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)

Time frame:Change at 24 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Rivastigmine Patchn=192 Participants	-0.5	6.70
Rivastigmine Capsulesn=188 Participants	-0.7	6.74

Secondary/protocol endpoint

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

Time frame:Change at 24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

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

Time frame:Change at 24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Rivastigmine Patchn=192 Participants	0.7	3.31
Rivastigmine Capsulesn=188 Participants	0.7	3.30

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score

Time frame:Change at 24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score

Time frame:Change at 24 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Rivastigmine Patchn=192 Participants	-1.9	11.02
Rivastigmine Capsulesn=188 Participants	-1.7	11.31

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score

Time frame:Change at 24 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score

Time frame:Change at 24 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Rivastigmine PatchNPI-12: Total score (frequency x severity)n=192 Participants	-1.3	11.22
NPI-10: Total score (frequency x severity)n=192 Participants	-1.2	9.84
NPI-D: Distress score (frequency x severity)n=192 Participants	-0.4	5.65
Rivastigmine CapsulesNPI-12: Total score (frequency x severity)n=188 Participants	-1.3	11.98
NPI-10: Total score (frequency x severity)n=188 Participants	-1.3	10.46
NPI-D: Distress score (frequency x severity)n=188 Participants	-0.6	5.88

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)

Time frame:Change at 24 weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)

Time frame:Change at 24 weeks

change from baseline, improvement

Posted result

Group	Value (number), participants	Reported bounds
Rivastigmine Patchmarked improvementn=192 Participants	1	-
Moderate improvementn=192 Participants	10	-
Minimal improvementn=192 Participants	68	-
No changen=192 Participants	67	-
Minimal worseningn=192 Participants	38	-
Moderate worseningn=192 Participants	7	-
Marked worseningn=192 Participants	1	-
Rivastigmine Capsulesmarked improvementn=188 Participants	1	-
Moderate improvementn=188 Participants	12	-
Minimal improvementn=188 Participants	59	-
No changen=188 Participants	74	-
Minimal worseningn=188 Participants	35	-
Moderate worseningn=188 Participants	6	-
Marked worseningn=188 Participants	0	-

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.