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

Phase 4

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)
Drug: Rivastigmine patch (9.5 mg/day)
Drug: Rivastigmine capsules (6 mg to 12 mg/day)

Registration Number: NCT00549601

Lead Sponsor: Novartis

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 142

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)	Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)	-
Rivastigmine patch (9.5 mg/day)	Rivastigmine patch (9.5 mg/day)	-
Rivastigmine capsules (6 mg to 12 mg/day)	Rivastigmine capsules (6 mg to 12 mg/day)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study	Baseline to end of study (Month 3)	Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.	Baseline to end of study (Month 3)	Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken.
Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)	Baseline to end of study (Month 3)	Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).
Overall Caregiver Satisfaction With Treatment	At end of study (Month 3)	Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction.
Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3	Baseline to Month 1 and Month 3	The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.
Overall Patient Satisfaction With Treatment	At end of study (Month 3)	Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction.