Clinical trial NCT00549601: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's
rivastigmine
transdermal
safety
randomized
switch
patch
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 142
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study
timeFrame: Baseline to end of study (Month 3)
Secondary outcomes:
measure: Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)
timeFrame: Baseline to end of study (Month 3)
measure: Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.
timeFrame: Baseline to end of study (Month 3)
measure: Overall Caregiver Satisfaction With Treatment
timeFrame: At end of study (Month 3)
measure: Overall Patient Satisfaction With Treatment
timeFrame: At end of study (Month 3)
measure: Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3
timeFrame: Baseline to Month 1 and Month 3
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals, MD
role: STUDY_DIRECTOR
References: