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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)
  • 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).
• Drug: Rivastigmine patch (9.5 mg/day)
  • Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
• Drug: Rivastigmine capsules (6 mg to 12 mg/day)
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)
• Experimental: Rivastigmine patch (9.5 mg/day)
• Active Comparator: Rivastigmine capsules (6 mg to 12 mg/day)

Primary Measures

• Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study
  • Time Frame: Baseline to end of study (Month 3)
    Safety Issue?: Yes

Secondary Measures

• Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)
  • Time Frame: Baseline to end of study (Month 3)
    Safety Issue?: Yes
• Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.
  • Time Frame: Baseline to end of study (Month 3)
    Safety Issue?: Yes
• Overall Caregiver Satisfaction With Treatment
  • Time Frame: At end of study (Month 3)
    Safety Issue?: No
• Overall Patient Satisfaction With Treatment
  • Time Frame: At end of study (Month 3)
    Safety Issue?: No
• 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
    Safety Issue?: No

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.

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 Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals, MD Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

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