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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00549601
• Date of registration: 24/10/2007
• Primary sponsor: Novartis
• Public title: 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
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 142
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00549601
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Novartis Pharmaceuticals, MD
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

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

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

Drug: Rivastigmine patch (9.5 mg/day)

Primary Outcome(s)

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)]

Secondary Outcome(s)

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]

Overall Caregiver Satisfaction With Treatment [Time Frame: At end of study (Month 3)]

Overall Patient Satisfaction With Treatment [Time Frame: At end of study (Month 3)]

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)]

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)]

Secondary ID(s)

CENA713DES07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors