CompletedPhase 3Results posted

Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)

A 24-week, Multicenter, Parallel-group, Randomized,Double-blind Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Methods of Rivastigmine Patch (ENA713D/ONO-2540) in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-20)

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

216

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-20

Primary endpoint

•Adverse Events Leading to Study Drug Discontinuation

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 IDCENA713D1303

NCT IDNCT01614886

Timeline

Milestones

Study first posted2012-06-08estimated

Study start2012-07 (month precision)

Primary completion2014-05actual (month precision)

Study completion2014-05actual (month precision)

Results first posted2015-05-12estimated

Last update posted2016-08-01estimated

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 ≥ 10 and ≤ 20 at baseline

Exclusion criteria

•Any medical or neurological conditions other than AD that could explain the patient's dementia

•A current diagnosis of probable or possible vascular dementia

•A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)

•A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.

•Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.

•an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk

•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

Other clinical outcomes

Safety / tolerability / PK

Global cognition

4 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, 8,16, and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and 24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, 8,16, and 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Rivastigmine Patch 1 StepWeek 8 (n=99, 100)n=104 Participants	-1.3	3.94
Week 16 (n=100, 100)n=104 Participants	-1.6	5.01
Week 24 (n=100, 100)n=104 Participants	-1.6	4.66
Rivastigmine Patch 3 StepWeek 8 (n=99, 100)n=105 Participants	-0.9	4.49
Week 16 (n=100, 100)n=105 Participants	-1.2	5.48
Week 24 (n=100, 100)n=105 Participants	-1.8	5.58

Secondary/registry result

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

Time frame:Baseline and 24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale	Standard deviation
Rivastigmine Patch 1 Stepn=94 Participants	0.6	2.91
Rivastigmine Patch 3 Stepn=88 Participants	0.5	3.15

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation

Time frame:Up to 24 weeks

threshold achievement, event

Primary/registry result

Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation

Time frame:Up to 24 weeks

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Rivastigmine Patch 1 Stepn=107 Participants	15	-
Rivastigmine Patch 3 Stepn=108 Participants	18.5	-

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint

Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly

Time frame:4, 8, 12,16, 20 and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

The Percentage of Treatment Retention.

Time frame:Up to 24 weeks

threshold achievement, improvement

Secondary/registry result

Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly

Time frame:4, 8, 12,16, 20 and 24 weeks

change from baseline, improvement

Posted result

Group	Value (number), Participants	Reported bounds
Rivastigmine Patch 1 StepWeek 4n=104 Participants	22	-
Week 8n=104 Participants	35	-
Week 12n=104 Participants	37	-
Week 16n=104 Participants	35	-
Week 20n=104 Participants	32	-
Week 24n=104 Participants	39	-
Rivastigmine Patch 3 StepWeek 4n=105 Participants	23	-
Week 8n=105 Participants	26	-
Week 12n=105 Participants	33	-
Week 16n=105 Participants	31	-
Week 20n=105 Participants	32	-
Week 24n=105 Participants	38	-

Secondary/registry result

The Percentage of Treatment Retention.

Time frame:Up to 24 weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Rivastigmine Patch 1 Stepn=107 Participants	71	-
Rivastigmine Patch 3 Stepn=108 Participants	69.4	-

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.