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
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day); Rivastigmine patch (9.5 mg/day); Rivastigmine capsules (6 mg to 12 mg/day)
Intervention description: Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).; Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).; Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
Intervention MeSH terms: Rivastigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Alzheimer's; rivastigmine; transdermal; safety; randomized; switch; patch

Summary:

      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.
    

Eligibility criteria:

        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.