KAPA

CompletedPhase 4Results posted

Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

A Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease

Lead sponsor

Novartis

Asset

Rivastigmine

Listed sites

Recruiting sites

Enrollment

142

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any

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 IDCENA713DES07

NCT IDNCT00549601

Timeline

Milestones

Study start2007-09 (month precision)

Study first posted2007-10-26estimated

Primary completion2009-04actual (month precision)

Study completion2009-04actual (month precision)

Last update posted2011-03-24estimated

Results first posted2011-03-24estimated

Assets

Drug assets

Rivastigmine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Meet DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score > 10 and < 26

•Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study

•Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver

•Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study

Exclusion criteria

•A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)

•Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)

•History of allergy to topical products containing vitamin E

•Taken any of the following substances prior to randomization:

-succinylcholine-type muscle relaxants during the previous 2 weeks

-an investigational drug during the previous 4 weeks

Other protocol-defined inclusion/exclusion criteria applied to the study.

Endpoints (12)

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

Caregiver / quality of life

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3

Time frame:Baseline to Month 1 and Month 3

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result