CompletedPhase 3Results posted

Safety of Switching From Donepezil to Rivastigmine Patch in Patients With Probable Alzheimer's Disease

A Prospective, 5-Week, Open-Label, Randomized, Multi-Center, Parallel-Group Study With a 20-Week, Open-Label Extension Evaluating the Tolerability and Safety of Switching From Donepezil to an Initial Dose of 5 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

262

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10•Study partner/caregiver required•AD symptomatic therapy: stable ≥6 months

Primary endpoint

•Number of Participants Who Discontinued From the Study Due to Any Reason During

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 IDCENA713DUS38

Secondary IDCENA713DUS38E1Novartis

NCT IDNCT00428389

Timeline

Milestones

Study start2007-01 (month precision)

Study first posted2007-01-30estimated

Primary completion2008-02actual (month precision)

Study completion2008-02actual (month precision)

Results first posted2011-06-27estimated

Last update posted2014-06-11estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Be at least 50 years of age;

•Have a diagnosis of probable Alzheimer's Disease;

•Have an MMSE score of > or = 10 and < or = 24;

•Must have a caregiver who is able to attend all study visits;

•Have received continuous treatment with donepezil for at least 6 months prior to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months

Exclusion criteria

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

•Have a history of malignancy of any organ system, treated or untreated, within the past 5 years;

•Have a history within the past year or current diagnosis of cerebrovascular disease;

•Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months;

•Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease);

•Digestive problems related to peptic ulcer;

•Urinary obstruction or current severe urinary tract infection;

•Abnormal thyroid function tests;

•Low folate or Vitamin B12;

•Have a disability that may prevent the patient from completing all study requirements;

•Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch;

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

Safety / tolerability / PK

Global cognition

Function / daily living

Behavior / neuropsychiatric

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study

Time frame:Baseline and Week 25 (end of the extension phase) and at the end of study

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study

Time frame:Baseline and Week 25 (end of the extension phase) and at the end of study

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Immediate SwitchAt Week 25 (n= 96, 106)n=131 Participants	-0.7	3.58
At the End of Study (n= 115, 118)n=131 Participants	-0.5	3.62
Delayed SwitchAt Week 25 (n= 96, 106)n=130 Participants	-0.4	3.94
At the End of Study (n= 115, 118)n=130 Participants	-0.3	4.11

Function / daily living

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study

Time frame:Baseline, Week 25 (end of the extension phase) and at the end of Study

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study

Time frame:Baseline, Week 25 (end of the extension phase) and at the end of Study

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Immediate SwitchAt Week 25 (n= 95, 107)n=131 Participants	-3.9	8.72
At the End of Study (n= 113, 117)n=131 Participants	-3.1	9.44
Delayed SwitchAt Week 25 (n= 95, 107)n=130 Participants	-4.2	9.91
At the End of Study (n= 113, 117)n=130 Participants	-4.2	9.65

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.

Time frame:Baseline, Week 25 (end of the extension phase) and at End of Study

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.

Time frame:Baseline, Week 25 (end of the extension phase) and at End of Study

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Immediate SwitchAt week 25 (n= 95, 107)n=131 Participants	-0.1	9.53
At the End of Study (n= 114, 118)n=131 Participants	-0.8	11.22
Delayed SwitchAt week 25 (n= 95, 107)n=130 Participants	0.4	12.92
At the End of Study (n= 114, 118)n=130 Participants	0.5	12.36

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study

Time frame:Baseline through the end of the core phase of the study (Week 5)

event count, event

Primary/registry result

Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study

Time frame:Baseline through the end of the core phase of the study (Week 5)

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
Immediate Switchn=131 Participants	11	-
Delayed Switchn=130 Participants	10	-

Secondary/protocol endpoint

Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study

Time frame:Baseline through the end of study (25 weeks)

event count, event

Secondary/protocol endpoint

Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase

Time frame:From week 5 through the end of extension phase (25 weeks)

event count, event

Secondary/registry result

Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study

Time frame:Baseline through the end of study (25 weeks)

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
Immediate Switchn=131 Participants	23	-
Delayed Switchn=130 Participants	15	-

Secondary/registry result

Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase

Time frame:From week 5 through the end of extension phase (25 weeks)

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
Immediate Switchn=117 Participants	32	-
Delayed Switchn=117 Participants	26	-

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25

Time frame:Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25

Time frame:Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
Immediate SwitchAt Week 5 (n= 116, 114)n=131 Participants	3.9	0.85
At Week 25 (n= 105, 109)n=131 Participants	4.1	1.16
Delayed SwitchAt Week 5 (n= 116, 114)n=130 Participants	4.0	0.84
At Week 25 (n= 105, 109)n=130 Participants	4.3	0.96

Publications (1)

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

Farlow MR, Alva G, Meng X, Olin JT. A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer's disease: a post hoc analysis. Curr Med Res Opin. 2010 Feb;26(2):263-9. doi: 10.1185/03007990903434914.
PMID19929593via DERIVED

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.