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CompletedPhase 4

Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease Switched From Cholinesterase Inhibitors

A 24-week, Open-label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Rivastigmine Patch in Patients With Mild to Moderate Alzheimer's Disease (MMSE 10-23) Switched From Cholinesterase Inhibitors (Donepezil, Galantamine)

Asset

Rivastigmine

Listed sites

11

Recruiting sites

-

Enrollment

52

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10

Primary endpoint

•The Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J 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 IDCENA713D1403
NCT IDNCT01529619

Timeline

Milestones

Study first posted2012-02-09estimated
Study start2012-03 (month precision)
Primary completion2013-12actual (month precision)
Study completion2013-12actual (month precision)
Last update posted2016-11-18estimated

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 > or = 10 and < or = 23
•Continuous treatment with donepezil ≤ 5 mg/day or galantamine ≤ 24 mg/day for 4 weeks prior to baseline visit
•Patients having difficulties being treated orally with ChE inhibitors (donepezil or galantamine) as judged by the investigator. Difficulties are defined as:
•Inadequate compliance with the ChE inhibitors at screening and baseline
•Presence of caregiver's burden for administering drugs orally at screening and baseline
•Inadequate treatment (efficacious dose cannot be reached or inadequate compliance) with the ChE inhibitors because of adverse events at screening and baseline
•Patients with swallowing difficulties at screening and baseline

Exclusion criteria

•A current DSM-IV diagnosis of major depression
•Taken rivastigmine in the past
•A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS)

Other protocol-defined inclusion/exclusion criteria may apply

Endpoints (7)

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
2
Caregiver / quality of life
2
Function / daily living
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Global cognition

2 endpoints
Primary/protocol endpoint

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

Time frame:Baseline and Week 24

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia (DAD)

Time frame:Baseline and Week 24

change from baseline, improvement

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Modified Crichton Scale

Time frame:Baseline and Week 4, 8, 12, 16, 20, 24

change from baseline, improvement

Secondary/protocol endpoint

Formulation usability questionnaire

Time frame:Week 24

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse Events, Serious Adverse Events, Adverse event leading to discontinuation of study drug

Time frame:Week 24

event count, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Japanese version of the Clinical global impression of change (J-CGIC)

Time frame:Week 4, 8, 12, 16, 20, 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.