A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease
Background: As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer’s disease (AD) in 64 countries. Methods: This 24-week, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the 5-cm2 (9-mg loading dose; 4.6 mg/24...
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| Format: | Article |
| Language: | English |
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Karger Publishers
2011-06-01
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| Series: | Dementia and Geriatric Cognitive Disorders Extra |
| Subjects: | |
| Online Access: | http://www.karger.com/Article/FullText/328929 |
| _version_ | 1819075355824095232 |
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| author | Yu Nakamura Yukimichi Imai Masahiro Shigeta Ana Graf Toru Shirahase Hyosung Kim Akifumi Fujii Joji Mori Akira Homma |
| author_facet | Yu Nakamura Yukimichi Imai Masahiro Shigeta Ana Graf Toru Shirahase Hyosung Kim Akifumi Fujii Joji Mori Akira Homma |
| author_sort | Yu Nakamura |
| collection | DOAJ |
| description | Background: As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer’s disease (AD) in 64 countries. Methods: This 24-week, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the 5-cm2 (9-mg loading dose; 4.6 mg/24 h delivery rate) and 10-cm2 (18-mg loading dose; 9.5 mg/24 h delivery rate) rivastigmine patch in Japanese patients with AD. Results: In the primary analysis population (intent-to-treat last observation carried forward) at week 24, delayed deterioration was seen with the 10-cm2 patch versus placebo on the Japanese version of the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-J cog; p = 0.005) and the Japanese version of the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC plus-J; p = 0.067). Participants receiving the rivastigmine patch showed numerically less decline versus placebo at week 24 on the CIBIC plus-J, although this did not reach statistical significance. Statistical significance for the CIBIC plus-J was met following adjustment for body weight and baseline Mini-Mental State Examination score as dynamic allocation factors (p = 0.042) and on the Disability Assessment for Dementia (DAD; p = 0.024) and Mental Function Impairment (MENFIS; p = 0.016) subscales. Serious adverse events were rare and were consistent with the known safety profile of the rivastigmine patch. Conclusion: The rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with AD. |
| first_indexed | 2024-12-21T18:24:06Z |
| format | Article |
| id | doaj.art-752c75f6bfca4637bfe80e509795d760 |
| institution | Directory Open Access Journal |
| issn | 1664-5464 |
| language | English |
| last_indexed | 2024-12-21T18:24:06Z |
| publishDate | 2011-06-01 |
| publisher | Karger Publishers |
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| series | Dementia and Geriatric Cognitive Disorders Extra |
| spelling | doaj.art-752c75f6bfca4637bfe80e509795d7602022-12-21T18:54:27ZengKarger PublishersDementia and Geriatric Cognitive Disorders Extra1664-54642011-06-011116317910.1159/000328929328929A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s DiseaseYu NakamuraYukimichi ImaiMasahiro ShigetaAna GrafToru ShirahaseHyosung KimAkifumi FujiiJoji MoriAkira HommaBackground: As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer’s disease (AD) in 64 countries. Methods: This 24-week, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the 5-cm2 (9-mg loading dose; 4.6 mg/24 h delivery rate) and 10-cm2 (18-mg loading dose; 9.5 mg/24 h delivery rate) rivastigmine patch in Japanese patients with AD. Results: In the primary analysis population (intent-to-treat last observation carried forward) at week 24, delayed deterioration was seen with the 10-cm2 patch versus placebo on the Japanese version of the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-J cog; p = 0.005) and the Japanese version of the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC plus-J; p = 0.067). Participants receiving the rivastigmine patch showed numerically less decline versus placebo at week 24 on the CIBIC plus-J, although this did not reach statistical significance. Statistical significance for the CIBIC plus-J was met following adjustment for body weight and baseline Mini-Mental State Examination score as dynamic allocation factors (p = 0.042) and on the Disability Assessment for Dementia (DAD; p = 0.024) and Mental Function Impairment (MENFIS; p = 0.016) subscales. Serious adverse events were rare and were consistent with the known safety profile of the rivastigmine patch. Conclusion: The rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with AD.http://www.karger.com/Article/FullText/328929Alzheimerߣs diseaseCholinesterase inhibitorsJapaneseRandomized clinical trialRivastigmine |
| spellingShingle | Yu Nakamura Yukimichi Imai Masahiro Shigeta Ana Graf Toru Shirahase Hyosung Kim Akifumi Fujii Joji Mori Akira Homma A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease Dementia and Geriatric Cognitive Disorders Extra Alzheimerߣs disease Cholinesterase inhibitors Japanese Randomized clinical trial Rivastigmine |
| title | A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease |
| title_full | A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease |
| title_fullStr | A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease |
| title_full_unstemmed | A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease |
| title_short | A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease |
| title_sort | 24 week randomized double blind placebo controlled study to evaluate the efficacy safety and tolerability of the rivastigmine patch in japanese patients with alzheimer s disease |
| topic | Alzheimerߣs disease Cholinesterase inhibitors Japanese Randomized clinical trial Rivastigmine |
| url | http://www.karger.com/Article/FullText/328929 |
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