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      Galantamine versus Risperidone for Agitation in People with Dementia: A Randomized, Twelve-Week, Single-Center Study

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          Abstract

          Aims: To examine the effects of galantamine and risperidone on agitation in patients with dementia. Methods: A total of 100 patients with dementia and neuropsychiatric symptoms (mean age ± SD: 78.6 ± 7.5 years; 67% female) were included in this 12-week, randomized, parallel-group, controlled, single-center trial. The participants received galantamine (n = 50; target dose: 24 mg) or risperidone (n = 50; target dose: 1.5 mg) for 12 weeks. Results: Both galantamine and risperidone treatment resulted in reduced agitation. However, risperidone showed a significant advantage over galantamine both at week 3 (mean difference in total Cohen-Mansfield Agitation Inventory score: 3.7 points; p = 0.03) and at week 12 (4.3 points; p = 0.01). Conclusions: Agitation improved in both groups, even if the treatment effects were more pronounced in the risperidone group; however, the effects on cognition and other aspects of tolerability were stronger with galantamine.

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          Pharmacological treatment of neuropsychiatric symptoms of dementia: a review of the evidence.

          Kaycee Sink, Karen F. Holden, Kristine Yaffe (2005)
          Neuropsychiatric symptoms of dementia are common and associated with poor outcomes for patients and caregivers. Although nonpharmacological interventions should be the first line of treatment, a wide variety of pharmacological agents are used in the management of neuropsychiatric symptoms; therefore, concise, current, evidence-based recommendations are needed. To evaluate the efficacy of pharmacological agents used in the treatment of neuropsychiatric symptoms of dementia. A systematic review of English-language articles published from 1966 to July 2004 using MEDLINE, the Cochrane Database of Systematic Reviews, and a manual search of bibliographies was conducted. Inclusion criteria were double-blind, placebo-controlled, randomized controlled trials (RCTs) or meta-analyses of any drug therapy for patients with dementia that included neuropsychiatric outcomes. Trials reporting only depression outcomes were excluded. Data on the inclusion criteria, patients, methods, results, and quality of each study were independently abstracted. Twenty-nine articles met inclusion criteria. For typical antipsychotics, 2 meta-analyses and 2 RCTs were included. Generally, no difference among specific agents was found, efficacy was small at best, and adverse effects were common. Six RCTs with atypical antipsychotics were included; results showed modest, statistically significant efficacy of olanzapine and risperidone, with minimal adverse effects at lower doses. Atypical antipsychotics are associated with an increased risk of stroke. There have been no RCTs designed to directly compare the efficacy of typical and atypical antipsychotics. Five trials of antidepressants were included; results showed no efficacy for treating neuropsychiatric symptoms other than depression, with the exception of 1 study of citalopram. For mood stabilizers, 3 RCTs investigating valproate showed no efficacy. Two small RCTs of carbamazepine had conflicting results. Two meta-analyses and 6 RCTs of cholinesterase inhibitors generally showed small, although statistically significant, efficacy. Two RCTs of memantine also had conflicting results for treatment of neuropsychiatric symptoms. Pharmacological therapies are not particularly effective for management of neuropsychiatric symptoms of dementia. Of the agents reviewed, the atypical antipsychotics risperidone and olanzapine currently have the best evidence for efficacy. However, the effects are modest and further complicated by an increased risk of stroke. Additional trials of cholinesterase inhibitors enrolling patients with high levels of neuropsychiatric symptoms may be warranted.
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            The prevalence of psychiatric symptoms and behavioural disturbances and the use of psychotropic drugs in Norwegian nursing homes.

            Geir Selbæk, Øyvind Kirkevold, Knut Engedal (2007)
            Psychiatric and behavioural symptoms in dementia are associated with a range of negative outcomes, including institutional placement and the widespread use of psychotropic drugs in spite of limited evidence for their efficacy. To determine the prevalence of psychiatric and behavioural symptoms and the pattern of psychotropic drug prescription in patients with various degrees of dementia. A sample of 1,163 non-selected nursing home patients were assessed by means of the Neuropsychiatric Inventory, the Clinical Dementia Rating scale and Lawton's activities of daily living scale. In addition, information was collected from the patients' records. Dementia was found in 81% of the patients and 72% of them had clinically significant psychiatric and behavioural symptoms. The frequencies of symptoms increased with the severity of the dementia. Psychotropic medication was being prescribed to 75% of patients with dementia. There was a significant relationship between the type of drug and the symptom for which it had been dispensed. Psychiatric and behavioural symptoms are frequent in nursing homes and the rate increases with the progression of the dementia. Systematic programmes are needed for disseminating skills and providing guidance regarding the evaluation and treatment of these symptoms in nursing homes.
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              Cognitive effects of atypical antipsychotic medications in patients with Alzheimer's disease: outcomes from CATIE-AD.

              Wendy J. Mack, Ling-Ling Zheng, D Sultzer … (2011)
              The impact of the atypical antipsychotics olanzapine, quetiapine, and risperidone on cognition in patients with Alzheimer's disease is unclear. The authors assessed the effects of time and treatment on neuropsychological functioning during the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer's Disease study (CATIE-AD). CATIE-AD included 421 outpatients with Alzheimer's disease and psychosis or agitated/aggressive behavior who were randomly assigned to receive masked, flexible-dose olanzapine, quetiapine, risperidone, or placebo. Based on their clinicians' judgment, patients could discontinue the originally assigned medication and receive another randomly assigned medication. Patients were followed for 36 weeks, and cognitive assessments were obtained at baseline and at 12, 24, and 36 weeks. Outcomes were compared for 357 patients for whom data were available for at least one cognitive measure at baseline and one follow-up assessment that took place after they had been on their prescribed medication or placebo for at least 2 weeks. Overall, patients showed steady, significant declines over time in most cognitive areas, including in scores on the Mini-Mental State Examination (MMSE; -2.4 points over 36 weeks) and the cognitive subscale of the Alzheimer's Disease Assessment Scale (-4.4 points). Cognitive function declined more in patients receiving antipsychotics than in those given placebo on multiple cognitive measures, including the MMSE, the cognitive subscale of the Brief Psychiatric Rating Scale, and a cognitive summary score summarizing change on 18 cognitive tests. In CATIE-AD, atypical antipsychotics were associated with worsening cognitive function at a magnitude consistent with 1 year's deterioration compared with placebo. Further cognitive impairment is an additional risk of treatment with atypical antipsychotics that should be considered when treating patients with Alzheimer's disease.
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                Author and article information

                Journal
                Journal ID (publisher-id): DEM
                Journal ID (nlm-ta): Dement Geriatr Cogn Disord
                Journal ID (doi): 10.1159/issn.1420-8008
                Title: Dementia and Geriatric Cognitive Disorders
                Publisher: S. Karger AG
                ISSN (Print): 1420-8008
                ISSN (Electronic): 1421-9824
                Publication date Subscription-year: 2014
                Publication date (Print): August 2014
                Publication date (Electronic): 25 June 2014
                Volume: 38
                Issue: 3-4
                Pages: 234-244
                Affiliations
                aDepartment of Neurobiology, Caring Sciences and Society (NVS), Division of Clinical Geriatrics, Karolinska Institutet, and bDepartment of Geriatric Medicine, Karolinska University Hospital Huddinge, Stockholm, Sweden; cResearch Department, Stavanger University Hospital, and dDepartment of Mathematics and Natural Sciences, University of Stavanger, Stavanger, Norway
                Author notes
                *Yvonne Freund-Levi, Department of Neurobiology, Caring Sciences and Society (NVS), Division of Clinical Geriatrics, Karolinska Institutet, SE-146 86 Stockholm (Sweden), E-Mail Yvonne.Freund-Levi@ki.se
                Article
                Publisher ID: 362204 Other ID: Dement Geriatr Cogn Disord 2014;38:234-244
                DOI: 10.1159/000362204
                PubMed ID: 24969380
                SO-VID: 1f580dcb-246f-4a8d-91b7-312658579230
                Copyright © © 2014 S. Karger AG, Basel
                License:

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. 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
                Date accepted : 13 March 2014
                Page count
                Figures: 2, Tables: 3, Pages: 11
                Categories
                Subject: Original Research Article

                ScienceOpen disciplines: Geriatric medicine,Neurology,Cardiovascular Medicine,Neurosciences,Clinical Psychology & Psychiatry,Public health
                Keywords: Agitation,Galantamine,Risperidone,Dementia,Behavioral and psychological symptoms of dementia,Neuropsychiatric symptoms
                Data availability:
                ScienceOpen disciplines: Geriatric medicine, Neurology, Cardiovascular Medicine, Neurosciences, Clinical Psychology & Psychiatry, Public health
                Keywords: Agitation, Galantamine, Risperidone, Dementia, Behavioral and psychological symptoms of dementia, Neuropsychiatric symptoms

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