Bupropion for the Treatment of Apathy in Alzheimer Disease: A Randomized Clinical Trial

Apathy is a frequent neuropsychiatric symptom in dementia of Alzheimer type and negatively affects the disease course and patients' and caregivers' quality of life. Effective treatment options are needed. To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibit...

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Veröffentlicht in:JAMA network open 2020-05, Vol.3 (5), p.e206027
Hauptverfasser: Maier, Franziska, Spottke, Annika, Bach, Jan-Philipp, Bartels, Claudia, Buerger, Katharina, Dodel, Richard, Fellgiebel, Andreas, Fliessbach, Klaus, Frölich, Lutz, Hausner, Lucrezia, Hellmich, Martin, Klöppel, Stefan, Klostermann, Arne, Kornhuber, Johannes, Laske, Christoph, Peters, Oliver, Priller, Josef, Richter-Schmidinger, Tanja, Schneider, Anja, Shah-Hosseini, Kija, Teipel, Stefan, von Arnim, Christine A F, Wiltfang, Jens, Jessen, Frank
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creator Maier, Franziska
Spottke, Annika
Bach, Jan-Philipp
Bartels, Claudia
Buerger, Katharina
Dodel, Richard
Fellgiebel, Andreas
Fliessbach, Klaus
Frölich, Lutz
Hausner, Lucrezia
Hellmich, Martin
Klöppel, Stefan
Klostermann, Arne
Kornhuber, Johannes
Laske, Christoph
Peters, Oliver
Priller, Josef
Richter-Schmidinger, Tanja
Schneider, Anja
Shah-Hosseini, Kija
Teipel, Stefan
von Arnim, Christine A F
Wiltfang, Jens
Jessen, Frank
description Apathy is a frequent neuropsychiatric symptom in dementia of Alzheimer type and negatively affects the disease course and patients' and caregivers' quality of life. Effective treatment options are needed. To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type. This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019. Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study. Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks. A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (
doi_str_mv 10.1001/jamanetworkopen.2020.6027
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Effective treatment options are needed. To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type. This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019. Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study. Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks. A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (mean change, -0.27; 95% CI, -3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups. Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood. EU Clinical Trials Register Identifier: 2007-005352-17.</description><identifier>ISSN: 2574-3805</identifier><identifier>EISSN: 2574-3805</identifier><identifier>DOI: 10.1001/jamanetworkopen.2020.6027</identifier><identifier>PMID: 32463470</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Activities of daily living ; Aged ; Alzheimer Disease - drug therapy ; Alzheimer Disease - psychology ; Antidepressive Agents, Second-Generation - adverse effects ; Antidepressive Agents, Second-Generation - therapeutic use ; Apathy ; Apathy - drug effects ; Bupropion - adverse effects ; Bupropion - therapeutic use ; Clinical trials ; Dementia ; Double-Blind Method ; Female ; Humans ; Male ; Mental Status and Dementia Tests ; Online Only ; Original Investigation ; Psychiatry ; Quality of life</subject><ispartof>JAMA network open, 2020-05, Vol.3 (5), p.e206027</ispartof><rights>2020. 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Effective treatment options are needed. To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type. This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019. Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study. Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks. A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (mean change, -0.27; 95% CI, -3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups. Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood. 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Spottke, Annika ; Bach, Jan-Philipp ; Bartels, Claudia ; Buerger, Katharina ; Dodel, Richard ; Fellgiebel, Andreas ; Fliessbach, Klaus ; Frölich, Lutz ; Hausner, Lucrezia ; Hellmich, Martin ; Klöppel, Stefan ; Klostermann, Arne ; Kornhuber, Johannes ; Laske, Christoph ; Peters, Oliver ; Priller, Josef ; Richter-Schmidinger, Tanja ; Schneider, Anja ; Shah-Hosseini, Kija ; Teipel, Stefan ; von Arnim, Christine A F ; Wiltfang, Jens ; Jessen, Frank</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a363t-4e24ba883340186328fd9d431a8a964375a25864dd6426759c36ce98f6d2fe993</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Activities of daily living</topic><topic>Aged</topic><topic>Alzheimer Disease - drug therapy</topic><topic>Alzheimer Disease - psychology</topic><topic>Antidepressive Agents, Second-Generation - adverse effects</topic><topic>Antidepressive Agents, Second-Generation - therapeutic use</topic><topic>Apathy</topic><topic>Apathy - drug effects</topic><topic>Bupropion - adverse effects</topic><topic>Bupropion - therapeutic use</topic><topic>Clinical trials</topic><topic>Dementia</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Mental Status and Dementia Tests</topic><topic>Online Only</topic><topic>Original Investigation</topic><topic>Psychiatry</topic><topic>Quality of life</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maier, Franziska</creatorcontrib><creatorcontrib>Spottke, Annika</creatorcontrib><creatorcontrib>Bach, Jan-Philipp</creatorcontrib><creatorcontrib>Bartels, Claudia</creatorcontrib><creatorcontrib>Buerger, Katharina</creatorcontrib><creatorcontrib>Dodel, Richard</creatorcontrib><creatorcontrib>Fellgiebel, Andreas</creatorcontrib><creatorcontrib>Fliessbach, Klaus</creatorcontrib><creatorcontrib>Frölich, Lutz</creatorcontrib><creatorcontrib>Hausner, Lucrezia</creatorcontrib><creatorcontrib>Hellmich, Martin</creatorcontrib><creatorcontrib>Klöppel, Stefan</creatorcontrib><creatorcontrib>Klostermann, Arne</creatorcontrib><creatorcontrib>Kornhuber, Johannes</creatorcontrib><creatorcontrib>Laske, Christoph</creatorcontrib><creatorcontrib>Peters, Oliver</creatorcontrib><creatorcontrib>Priller, Josef</creatorcontrib><creatorcontrib>Richter-Schmidinger, Tanja</creatorcontrib><creatorcontrib>Schneider, Anja</creatorcontrib><creatorcontrib>Shah-Hosseini, Kija</creatorcontrib><creatorcontrib>Teipel, Stefan</creatorcontrib><creatorcontrib>von Arnim, Christine A F</creatorcontrib><creatorcontrib>Wiltfang, Jens</creatorcontrib><creatorcontrib>Jessen, Frank</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health &amp; 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Effective treatment options are needed. To examine the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type. This 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted in a psychiatric and neurological outpatient setting between July 2010 and July 2014 in Germany. Patients with mild-to-moderate dementia of Alzheimer type and clinically relevant apathy were included. Patients with additional clinically relevant depressed mood were excluded. Data analyses were performed between August 2018 and August 2019. Patients received either bupropion or placebo (150 mg for 4 weeks plus 300 mg for 8 weeks). In case of intolerability of 300 mg, patients continued to receive 150 mg throughout the study. Change on the Apathy Evaluation Scale-Clinician Version (AES-C) (score range, 18-72 points) between baseline and week 12 was the primary outcome parameter. Secondary outcome parameters included measures of neuropsychiatric symptoms, cognition, activities of daily living, and quality of life. Outcome measures were assessed at baseline and at 4, 8, and 12 weeks. A total of 108 patients (mean [SD] age, 74.8 [5.9] years; 67 men [62%]) were included in the intention-to-treat analysis, with 54 randomized to receive bupropion and 54 randomized to receive placebo. The baseline AES-C score was comparable between the bupropion group and the placebo group (mean [SD], 52.2 [8.7] vs 50.4 [8.2]). After controlling for the baseline AES-C score, site, and comedication with donepezil or galantamine, the mean change in the AES-C score between the bupropion and placebo groups was not statistically significant (mean change, 2.22; 95% CI, -0.47 to 4.91; P = .11). Results on secondary outcomes showed statistically significant differences between bupropion and placebo in terms of total neuropsychiatric symptoms (mean change, 5.52; 95% CI, 2.00 to 9.04; P = .003) and health-related quality of life (uncorrected for multiple comparisons; mean change, -1.66; 95% CI, -3.01 to -0.31; P = .02) with greater improvement in the placebo group. No statistically significant changes between groups were found for activities of daily living (mean change, -2.92; 95% CI, -5.89 to 0.06; P = .05) and cognition (mean change, -0.27; 95% CI, -3.26 to 2.73; P = .86). The numbers of adverse events (bupropion group, 39 patients [72.2%]; placebo group, 33 patients [61.1%]) and serious adverse events (bupropion group, 5 patients [9.3%]; placebo group, 2 patients [3.7%]) were comparable between groups. Although it is safe, bupropion was not superior to placebo for the treatment of apathy in patients with dementia of Alzheimer type in the absence of clinically relevant depressed mood. EU Clinical Trials Register Identifier: 2007-005352-17.</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>32463470</pmid><doi>10.1001/jamanetworkopen.2020.6027</doi><oa>free_for_read</oa></addata></record>
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subjects Activities of daily living
Aged
Alzheimer Disease - drug therapy
Alzheimer Disease - psychology
Antidepressive Agents, Second-Generation - adverse effects
Antidepressive Agents, Second-Generation - therapeutic use
Apathy
Apathy - drug effects
Bupropion - adverse effects
Bupropion - therapeutic use
Clinical trials
Dementia
Double-Blind Method
Female
Humans
Male
Mental Status and Dementia Tests
Online Only
Original Investigation
Psychiatry
Quality of life
title Bupropion for the Treatment of Apathy in Alzheimer Disease: A Randomized Clinical Trial
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