Universität zu Köln

Maier, Franziska, Spottke, Annika, Bach, Jan-Philipp, Bartels, Claudia, Buerger, Katharina, Dodel, Richard, Fellgiebel, Andreas, Fliessbach, Klaus, Froelich, Lutz, Hausner, Lucrezia, Hellmich, Martin, Kloeppel, Stefan, Klostermann, Arne, Kornhuber, Johannes, Laske, Christoph, Peters, Oliver, Priller, Josef, Richter-Schmidinger, Tanja, Schneider, Anja, Shah-Hosseini, Kija ORCID: 0000-0001-9616-6942, Teipel, Stefan, von Arnim, Christine A. F., Wiltfang, Jens and Jessen, Frank (2020). Bupropion for the Treatment of Apathy in Alzheimer Disease A Randomized Clinical Trial. JAMA Netw. Open, 3 (5). CHICAGO: AMER MEDICAL ASSOC. ISSN 2574-3805

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Abstract

This randomized clinical trial examines the efficacy and safety of the dopamine and noradrenaline reuptake inhibitor bupropion in the treatment of apathy in patients with dementia of Alzheimer type. Importance 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. Objective 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. Design, Setting, and Participants 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. Interventions 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. Main Outcomes and Measures 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. Results 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. Conclusions and Relevance 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. Question Is bupropion an effective and safe treatment for apathy in nondepressed patients with dementia of Alzheimer type? Findings In this 12-week, multicenter, double-blind, placebo-controlled, randomized clinical trial, 54 patients received bupropion and 54 received placebo. The mean change in the Apathy Evaluation Scale-Clinician Version score was not statistically significant between the treatment groups. Meaning Bupropion did not improve apathy in patients with dementia of Alzheimer type without depressed mood.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Maier, Franziska UNSPECIFIED UNSPECIFIED UNSPECIFIED Spottke, Annika UNSPECIFIED UNSPECIFIED UNSPECIFIED Bach, Jan-Philipp UNSPECIFIED UNSPECIFIED UNSPECIFIED Bartels, Claudia UNSPECIFIED UNSPECIFIED UNSPECIFIED Buerger, Katharina UNSPECIFIED UNSPECIFIED UNSPECIFIED Dodel, Richard UNSPECIFIED UNSPECIFIED UNSPECIFIED Fellgiebel, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Fliessbach, Klaus UNSPECIFIED UNSPECIFIED UNSPECIFIED Froelich, Lutz UNSPECIFIED UNSPECIFIED UNSPECIFIED Hausner, Lucrezia UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellmich, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Kloeppel, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Klostermann, Arne UNSPECIFIED UNSPECIFIED UNSPECIFIED Kornhuber, Johannes UNSPECIFIED UNSPECIFIED UNSPECIFIED Laske, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Peters, Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Priller, Josef UNSPECIFIED UNSPECIFIED UNSPECIFIED Richter-Schmidinger, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Schneider, Anja UNSPECIFIED UNSPECIFIED UNSPECIFIED Shah-Hosseini, Kija UNSPECIFIED orcid.org/0000-0001-9616-6942 UNSPECIFIED Teipel, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED von Arnim, Christine A. F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiltfang, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Jessen, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-332725
DOI:	10.1001/jamanetworkopen.2020.6027
Journal or Publication Title:	JAMA Netw. Open
Volume:	3
Number:	5
Date:	2020
Publisher:	AMER MEDICAL ASSOC
Place of Publication:	CHICAGO
ISSN:	2574-3805
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NEUROPSYCHIATRIC SYMPTOMS; MULTIDIMENSIONAL APATHY; COGNITIVE IMPAIRMENT; DOUBLE-BLIND; DEPRESSION; DEMENTIA; METHYLPHENIDATE; PREVALENCE; DOPAMINE Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/33272