CompletedPhase 4Results posted

Tolerability of Rivastigmine Before and After Switching From Oral Formulation to Transdermal Patch in Alzheimer's Dementia

A 52-week, Prospective, Multi-center, Open-label Study to Assess the Tolerability of Rivastigmine Before and After Switching From Oral Formulation to Transdermal Patch in Patients With Alzheimer's Dementia in a Controlled Titration Schedule

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

121

actual

Study population

Alzheimer’s disease

Key I/E criterion

•mild-to-moderate AD

Primary endpoint

•Adverse Events, Serious Adverse Events, and Death

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 IDCENA713DTW04

NCT IDNCT01585272

Timeline

Milestones

Study first posted2012-04-25estimated

Study start2012-08 (month precision)

Primary completion2015-06actual (month precision)

Study completion2015-06actual (month precision)

Results first posted2016-11-10estimated

Last update posted2018-04-18actual

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

•With diagnosis of mild to moderate Alzheimer's disease.

•Mini-Mental Status Examination score of 10-26 within 3 months before starting oral rivastigmine treatment.

•A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria. The brain scan (magnetic resonance imaging (MRI) or computed tomography (CT) used for establishing that these criteria are met must have been available on the source document within one year prior to study participation.

•Patients who are currently taking or planned to receive Exelon 3 mg capsule twice-daily treatment.

•Written informed consent must be obtained before any assessment is performed.

•If female, must be surgically sterile or at least one year post-menopausal.

•Sufficient education to read, write, and communicate effectively.

•Capable of complying with the requirements of the study

Exclusion criteria

•Any advanced, severe or unstable disease that could interfere with study evaluation or completion or put patient at special risk.

•Any medical or neurological condition other than AD that could explain the patient's dementia (e.g., abnormal thyroid function tests, Vitamin B12 or folate deficiency, posttraumatic conditions, Huntington's disease, Parkinson's disease, syphilis).

•Active uncontrolled peptic ulceration, or gastrointestinal bleeding, within the previous 3 months prior to visit 1.

•A current diagnosis of active, uncontrolled seizure disorder.

•A history within the past year or current diagnosis of cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms).

•Bradycardia (< 50 beats per minute), sick sinus syndrome, conduction deficits (S-A block, second or third degree A-V block)

•Severe or unstable cardiovascular disease.

•Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.

•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes, or other components of the formulation.

•Current diagnosis of a systemic active skin disorder or lesion that would prevent accurate assessment of the adhesion and skin irritation potential of the patch.

•Previous lack of efficacy with cholinesterase inhibitors.

•History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. Patients with history of malignancy yet have been treated and defined as complete remission for more than 5 years are not excluded from study participation.

•Pregnant or nursing (lactating) women.

•Concurrently treated with succinylcholine, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol 2 weeks before the start of study drug and during the treatment period.

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 (unclassified)

Safety / tolerability / PK

Global cognition

4 endpoints

Secondary/protocol endpoint

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

Time frame:Baselin, week 16, 28 and 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

Time frame:Baseline, week 16, 28 and 52

ADAS-Cog

change from baseline, improvement

Secondary/registry result

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

Time frame:Baselin, week 16, 28 and 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), Score	Standard deviation
RivastigmineWeek 16 (n=90)n=102 Participants	-0.1	2.62
Week 28 (n=82)n=102 Participants	0.1	2.62
Week 52 (n=93)n=102 Participants	-1.0	3.48

Secondary/registry result

Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

Time frame:Baseline, week 16, 28 and 52

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Score	Standard deviation
RivastigmineWeek 16 (n=90)n=102 Participants	0.0	4.92
Week 28 (n=82)n=102 Participants	0.4	5.20
Week 52 (n=93)n=102 Participants	0.8	7.37

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Patients With Adverse Events, Serious Adverse Events, and Death

Time frame:Baseline through week 28

event count, event

Primary/registry result

Number of Patients With Adverse Events, Serious Adverse Events, and Death

Time frame:Baseline through week 28

event count, event

Posted result

Group	Value (number), Participants	Reported bounds
RivastigminePatients with at least one SAEsn=102 Participants	16	-
Patients with at least one AEn=102 Participants	94	-
Deathn=102 Participants	0	-

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

The Discontinuation Rate Due to the Treatment Switching From Oral Capsule to Rivastigmine Patch Treatment

Time frame:Baseline through week 52

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Patients Successfully Titrated to Rivastigmine Patch 10 cm^2

Time frame:Baseline through week 52

threshold achievement, improvement

Secondary/registry result/low confidence

The Discontinuation Rate Due to the Treatment Switching From Oral Capsule to Rivastigmine Patch Treatment

Time frame:Baseline through week 52

threshold achievement, improvement

Posted result

Group	Value (number), Participants	Reported bounds
RivastigmineExelon patch 5 cm 2:Week 4 - Week 28n=114 Participants	18	-
Exelon patch 10 cm 2: Week 28 - Week 52n=114 Participants	14	-

Secondary/registry result/low confidence

Percentage of Patients Successfully Titrated to Rivastigmine Patch 10 cm^2

Time frame:Baseline through week 52

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Rivastigminen=102 Participants	85.3	-

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.