CARE

CompletedPhase 4

Compliance and Tolerability of Rivastigmine Transdermal Patch 10 cm² in Patients With Probable Alzheimer's Disease.

A 24-week, Multi-center, Open-label Evaluation of Compliance and Tolerability of the Once-daily 10 cm² Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease.

Lead sponsor

Novartis Pharmaceuticals

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

380

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

Primary endpoint

•Proportion of patients who can reach the target rivastigmine patch size of 10

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 IDCENA713DAU01

NCT IDNCT00731224

Timeline

Milestones

Study start2008-07 (month precision)

Study first posted2008-08-08estimated

Primary completion2011-10actual (month precision)

Study completion2011-10actual (month precision)

Last update posted2017-03-28actual

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

•Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria;

•MMSE score of ≥10 and ≤ 26

Exclusion criteria

•Bradycardia (beats per minute less than 50)

•Body weight less than 40 kg;

•Hypersensitivity to cholinesterase inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply

Endpoints (3)

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

Other (unclassified)

Global cognition

1 endpoint

Secondary/protocol endpoint

Mini-Mental State Examination (MMSE), Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), Global Deterioration Scale (GDS), caregiver burden (Zarit Burden Interview).

Time frame:At baseline, wk 12 and wk 24

Mini-Mental State Examination (MMSE)

ratio, descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Proportion of patients who can reach the target rivastigmine patch size of 10 cm2 and stay on it for at least 8 weeks.

Time frame:At week 24

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Patient compliance (drug accounting)

Time frame:During 24 weeks

descriptive

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.