Phase 4
Completed N=142
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
Source: ClinicalTrials.gov NCT00549601 ↗Enrolled (actual)
142
Serious AEs
4.3%
Results posted
Mar 2011
Primary outcomePrimary: Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study — 4.65; 4.26; 6.12 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study |
4.65; 4.26; 6.12 | — |
| SECONDARY Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only) |
11.63; 17.02 | — |
| SECONDARY Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study. |
48.84; 55.32; 53.06 | — |
| SECONDARY Overall Caregiver Satisfaction With Treatment |
1; 3; 1; 18; 20; 10 | — |
| SECONDARY Overall Patient Satisfaction With Treatment |
0; 3; 1; 18; 14; 12 | — |
| SECONDARY Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3 |
0.12; 0.59; 1.00; -0.59; 0.12; -0.40 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00549601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.