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      Efficacy, Safety, and Tolerability of Switching from Oral Cholinesterase Inhibitors to Rivastigmine Transdermal Patch with 1-Step Titration in Patients with Mild to Moderate Alzheimer’s Disease: A 24-Week, Open-Label, Multicenter Study in Japan

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          Abstract

          Background: Few studies have investigated treatment options for patients with Alzheimer’s disease (AD) showing a poor response to oral cholinesterase inhibitors (ChEIs) in Japan. Objective: To investigate the efficacy and safety of switching from oral ChEIs to rivastigmine transdermal patch in patients with AD. Methods: In this multicenter, open-label, phase IV study in outpatient clinics in Japan, patients with mild-moderate AD who had a poor response to or experienced difficulty in continuing donepezil or galantamine were switched to rivastigmine transdermal patch (5 cm<sup>2</sup>; loaded dose 9 mg, delivery rate 4.6 mg/24 h) with a 1-step titration in week 4 (10 cm<sup>2</sup>; loaded dose 18 mg, delivery rate 9.5 mg/24 h), which was continued for 4 weeks in the titration period and 16 weeks in a maintenance period. The primary endpoint was the change in Mini-Mental State Examination (MMSE) total score from baseline to week 24. Results: A total of 118 patients were enrolled and switched to rivastigmine, of which 102 completed the 24-week study. The MMSE total score was essentially unchanged during the study, with a least-square mean change (SD) of −0.35 (2.64) at week 24 ( p = 0.1750). Exploratory analysis with a mixed-effect model comparing changes in MMSE between the pre- and post-switch periods suggested that switching to rivastigmine prevented a worsening of MMSE. Application site skin reactions/irritations occurred in 30.5% of patients overall, in 22.0% in the 8-week titration period, and in 10.2% in the 16-week maintenance period. Conclusion: Within-class switching from an oral ChEI to rivastigmine transdermal patch might be an efficacious and tolerable option for AD patients showing a poor or limited response to a prior oral ChEI.

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          Efficacy and safety of donepezil, galantamine, and rivastigmine for the treatment of Alzheimer’s disease: A systematic review and meta-analysis

          Pharmacologic treatments for Alzheimer’s disease include the cholinesterase inhibitors donepezil, galantamine, and rivastigmine. We reviewed their evidence by searching MEDLINE®, Embase, The Cochrane Library, and the International Pharmaceutical Abstracts from 1980 through 2007 (July) for placebo-controlled and comparative trials assessing cognition, function, behavior, global change, and safety. Thirty-three articles on 26 studies were included in the review. Meta-analyses of placebo-controlled data support the drugs’ modest overall benefits for stabilizing or slowing decline in cognition, function, behavior, and clinical global change. Three open-label trials and one double-blind randomized trial directly compared donepezil with galantamine and rivastigmine. Results are conflicting; two studies suggest no differences in efficacy between compared drugs, while one study found donepezil to be more efficacious than galantamine, and one study found rivastigmine to be more efficacious than donepezil. Adjusted indirect comparison of placebo-controlled data did not find statistically significant differences among drugs with regard to cognition, but found the relative risk of global response to be better with donepezil and rivastigmine compared with galantamine (relative risk = 1.63 and 1.42, respectively). Indirect comparisons also favored donepezil over galantamine with regard to behavior. Across trials, the incidence of adverse events was generally lowest for donepezil and highest for rivastigmine.
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            Contrasting results between caregiver's report and direct assessment of activities of daily living in patients affected by mild and very mild dementia: the contribution of the caregiver's personal characteristics.

            To determine the level of agreement between the primary caregiver's report on patient activities of daily living (ADLs) and ADLs assessed directly in a sample of patients affected by very mild and mild dementia and to assess whether this agreement is influenced by the caregiver's depressive symptoms and burden. Data were obtained from the baseline sample of the Mild Dementia Longitudinal Study, consisting of 111 consecutive patients affected by dementia with very mild to mild functional impairment (grades .5 and 1 on the Clinical Dementia Rating Scale). As is usual for patients referred to our Alzheimer's Unit, anamnestic, cognitive, functional and behavioral information are collected from the primary caregiver. Along with sociodemographic characteristics, caregivers' depressive symptoms (Beck Depression Inventory Scale) and burden (Nowak and Guest's Caregiver Burden Inventory Scale) were also evaluated. Patients underwent a performance-based assessment of the activities of daily living (DAFS) and direct assessment of physical function with the Physical Performance Test (PPT). Caregiver's report and direct observation have been compared for the following ADLs: dressing, toileting, walking, telephone use, shopping, and money use. Discriminant analyses were conducted to examine the degree of agreement between caregiver-report functional status and performance-based measures and whether additional agreement is attributable to caregiver's burden and depressive symptoms. The strength of the association between the caregiver's report and performance-based measures of ADLs is high for motor performance (walking), moderate to good for dressing, but only moderate for telephone, money use, and shopping. No association was found for toileting. The discrepancies between caregiver report and performance-based assessment were influenced substantially by the burden caused by demands and restrictions on a caregiver's time. With the exception of motor performance (walking), the caregiver's report and the performance-based assessment of functional status measure different aspects of a patient's functional status. Contrasts between the caregiver's report and observed ADL performance in mildly and very mildly demented patients are influenced by the caregiver's burden.
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              Effectiveness of Interventions for Caregivers of People With Alzheimer’s Disease and Related Major Neurocognitive Disorders: A Systematic Review

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                Author and article information

                Journal
                DEE
                DEE
                10.1159/issn.1664-5464
                Dementia and Geriatric Cognitive Disorders Extra
                S. Karger AG
                1664-5464
                2019
                May – August 2019
                15 August 2019
                : 9
                : 2
                : 302-318
                Affiliations
                [_a] aNovartis Pharma K.K., Tokyo, Japan
                [_b] bKatayama Medical Clinic, Okayama, Japan
                [_c] cFaculty of Medicine, University of Tsukuba, Ibaraki, Japan
                [_d] dYokufukai Hospital, Tokyo, Japan
                [_e] eIkebe Clinic, Shizuoka, Japan
                [_f] fTakeda General Hospital, Fukushima, Japan
                [_g] gHachioji Medical Center, Geriatric Medicine, Tokyo Medical University, Tokyo, Japan
                [_h] hDepartment of Neurology, Fukuoka University, Fukuoka, Japan
                [_i] iDepartment of Geriatric Medicine, Tokyo Medical University, Tokyo, Japan
                [_j] jSagamihara Kyodo Hospital, Kanagawa, Japan
                [_k] kDepartment of Neurology, Osaka Red Cross Hospital, Osaka, Japan
                [_l] lDepartment of Psychiatry, Osaka University Graduate School of Medicine, Osaka, Japan
                [_m] mDepartment of Neuropsychiatry, Kagawa University School of Medicine, Kagawa, Japan
                [_n] nDepartment of Neurology, Kurashiki Heisei Hospital, Okayama, Japan
                [_o] oNovartis Healthcare Pvt. Ltd., Data Sciences, SSP, PLS, Hyderabad, India
                Author notes
                *Yu Nakamura MD, PhD, Department of Neuropsychiatry, Kagawa University School of Medicine, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793 (Japan), E-Mail yunaka@med.kagawa-u.ac.jp
                Article
                501364 PMC6751467 Dement Geriatr Cogn Disord Extra 2019;9:302–318
                10.1159/000501364
                PMC6751467
                31572426
                75901ae8-15ab-4d02-9a13-b446c711a408
                © 2019 The Author(s) Published by S. Karger AG, Basel

                This article is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                : 04 June 2019
                : 05 June 2019
                Page count
                Figures: 6, Tables: 8, Pages: 17
                Categories
                Research Article

                Geriatric medicine,Neurology,Cardiovascular Medicine,Neurosciences,Clinical Psychology & Psychiatry,Public health
                Cholinesterase inhibitors,Alzheimer’s disease,Rivastigmine transdermal patch,Switching

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