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 (KAPA)

Novartis

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day); Drug: Rivastigmine capsules (6 mg to 12 mg/day); Drug: Rivastigmine patch (9.5 mg/day)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549601

CENA713DES07

Details and patient eligibility

About

This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.

Enrollment: 142 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 3 patient groups

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)

Experimental group

Treatment:

Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)

Rivastigmine patch (9.5 mg/day)

Experimental group

Treatment:

Drug: Rivastigmine patch (9.5 mg/day)

Rivastigmine capsules (6 mg to 12 mg/day)

Active Comparator group

Treatment:

Drug: Rivastigmine capsules (6 mg to 12 mg/day)