Official Title: “Feasibility of the Switch From Rivastigmine Capsules to Rivastigmine Transdermal Patch: Randomized, Open Label, Controlled Multicenter Study”

This study will use two doses of rivastigmine transdermal patch (5cm2, 10cm2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3mg/bid, 4,5mg/bid, 6mg/bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience and caregivers preferences of rivastigmine transdermal patch versus capsules.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: rivastigmine transdermal patch
• Drug: rivastigmine transdermal patch
• Drug: rivastigmine capsules

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3

Primary Measures

• The mean incidence of gastrointestinal adverse events between the two study groups.
  • Time Frame: At all visits during the study
    Safety Issue?: Yes

Secondary Measures

• The mean incidence of any adverse events between the two study groups.
  • Time Frame: At all visits during the study
    Safety Issue?: Yes
• The mean incidence of skin adverse events between the two study groups.
  • Time Frame: At all visits during the study
    Safety Issue?: Yes
• Caregiver / patient satisfaction with transdermal patch treatment.
  • Time Frame: At last visit
    Safety Issue?: No
• Changes in Mini Mental State Examination (MMSE in both transdermal patch treatment groups.
  • Time Frame: From baseline to visit 2 and last visit.
    Safety Issue?: No

Inclusion Criteria:

• Meet DSM-IV (Diagnostic & Statistical Manual of Mental Disorders) 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 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 (6mg of total daily dose) for at least 3 moths 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, (e.g., 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 (e.g. 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 may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals, MD Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00549601

Study ID Number: CENA713DES07

ClinicalTrials.gov Identifier: NCT00549601

Health Authority: Spain: Agencia Española del Medicamento