A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial)
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{"title"=>"A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (The DART-AD Trial)", "type"=>"journal", "authors"=>[{"first_name"=>"Clive", "last_name"=>"Ballard", "scopus_author_id"=>"35351371500"}, {"first_name"=>"Marisa Margallo", "last_name"=>"Lana", "scopus_author_id"=>"18836482200"}, {"first_name"=>"Megan", "last_name"=>"Theodoulou", "scopus_author_id"=>"24473876400"}, {"first_name"=>"Simon", "last_name"=>"Douglas", "scopus_author_id"=>"57198066105"}, {"first_name"=>"Rupert", "last_name"=>"McShane", "scopus_author_id"=>"7003565899"}, {"first_name"=>"Robin", "last_name"=>"Jacoby", "scopus_author_id"=>"7103078762"}, {"first_name"=>"Katja", "last_name"=>"Kossakowski", "scopus_author_id"=>"24174575000"}, {"first_name"=>"Ly Mee", "last_name"=>"Yu", "scopus_author_id"=>"7404164174"}, {"first_name"=>"Edmund", "last_name"=>"Juszczak", "scopus_author_id"=>"57192264856"}], "year"=>2008, "source"=>"PLoS Medicine", "identifiers"=>{"pmid"=>"18384230", "sgr"=>"43249092442", "doi"=>"10.1371/journal.pmed.0050076", "scopus"=>"2-s2.0-43249092442", "pui"=>"351649258", "isbn"=>"1549-1676\\r1549-1277 (Linking)", "issn"=>"15491277"}, "id"=>"4744ec8e-07c5-3e8f-a619-3d22e22f0824", "abstract"=>"BACKGROUND: There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease. METHODS AND FINDINGS: Design: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial. Setting: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom. Participants: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo. Interventions: Continue neuroleptic treatment for 12 mo or switch to an identical placebo. Outcome measures: Primary outcome was total Severe Impairment Battery (SIB) score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI). Results: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment), of whom 128 (78%) commenced treatment (64 continue/64 placebo). Of those, 26 were lost to follow-up (13 per arm), resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo) -0.4 (95% confidence interval [CI] -6.4 to 5.5), adjusted for baseline value (p = 0.9). For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively) in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment) -2.4 (95% CI -8.2 to 3.5), adjusted for baseline value (p = 0.4). Both results became more pronounced at 12 mo. There was some evidence to suggest that those patients with initial NPI >/= 15 benefited on neuropsychiatric symptoms from continuing treatment. CONCLUSIONS: For most patients with AD, withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status. Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms, but this benefit must be weighed against the side effects of therapy. Trial registration: Cochrane Central Registry of Controlled Trials/National Research Register (#ISRCTN33368770).", "link"=>"http://www.mendeley.com/research/randomised-blinded-placebocontrolled-trial-dementia-patients-continuing-stopping-neuroleptics-dartad", "reader_count"=>76, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Librarian"=>1, "Researcher"=>13, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>8, "Student > Master"=>9, "Other"=>16, "Student > Bachelor"=>8, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>4}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Librarian"=>1, "Researcher"=>13, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>8, "Student > Master"=>9, "Other"=>16, "Student > Bachelor"=>8, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>4}, "reader_count_by_subject_area"=>{"Unspecified"=>8, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>45, "Agricultural and Biological Sciences"=>5, "Neuroscience"=>2, "Arts and Humanities"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>4, "Chemistry"=>1, "Psychology"=>6, "Social Sciences"=>1, "Computer Science"=>1, "Decision Sciences"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>45}, "Neuroscience"=>{"Neuroscience"=>2}, "Chemistry"=>{"Chemistry"=>1}, "Social Sciences"=>{"Social Sciences"=>1}, "Decision Sciences"=>{"Decision Sciences"=>1}, "Psychology"=>{"Psychology"=>6}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Computer Science"=>{"Computer Science"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>8}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>4}, "Arts and Humanities"=>{"Arts and Humanities"=>1}}, "reader_count_by_country"=>{"Canada"=>1, "United States"=>2, "Ireland"=>1, "United Kingdom"=>2, "France"=>1, "Switzerland"=>1, "Spain"=>1}, "group_count"=>6}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/934447"], "description"=>"<p>Flow of Participants through the Trial</p>", "links"=>[], "tags"=>["neurological disorders"], "article_id"=>604890, "categories"=>["Neuroscience"], "users"=>["Clive Ballard", "Marisa Margallo Lana", "Megan Theodoulou", "Simon Douglas", "Rupert McShane", "Robin Jacoby", "Katja Kossakowski", "Ly-Mee Yu", "Edmund Juszczak"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0050076.g001", "stats"=>{"downloads"=>3, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_of_Participants_through_the_Trial_/604890", "title"=>"Flow of Participants through the Trial", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2008-04-01 01:21:30"}
  • {"files"=>["https://ndownloader.figshare.com/files/934744"], "description"=>"<p>Subgroup Analysis (Change in NPI from Baseline to 6 Months)</p>", "links"=>[], "tags"=>["npi", "baseline"], "article_id"=>605187, "categories"=>["Neuroscience"], "users"=>["Clive Ballard", "Marisa Margallo Lana", "Megan Theodoulou", "Simon Douglas", "Rupert McShane", "Robin Jacoby", "Katja Kossakowski", "Ly-Mee Yu", "Edmund Juszczak"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0050076.g003", "stats"=>{"downloads"=>1, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Subgroup_Analysis_Change_in_NPI_from_Baseline_to_6_Months_/605187", "title"=>"Subgroup Analysis (Change in NPI from Baseline to 6 Months)", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2008-04-01 01:26:27"}
  • {"files"=>["https://ndownloader.figshare.com/files/475325"], "description"=>"<div><h3>Background</h3><p>There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease.</p> <h3>Methods and Findings</h3><p>Design: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial.</p> <p>Setting: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom.</p> <p>Participants: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo.</p> <p>Interventions: Continue neuroleptic treatment for 12 mo or switch to an identical placebo.</p> <p>Outcome measures: Primary outcome was total Severe Impairment Battery (SIB) score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI).</p> <p>Results: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment), of whom 128 (78%) commenced treatment (64 continue/64 placebo). Of those, 26 were lost to follow-up (13 per arm), resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo) −0.4 (95% confidence interval [CI] −6.4 to 5.5), adjusted for baseline value (<em>p</em> = 0.9). For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (<em>n</em> = 56 and 53, respectively) in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment) −2.4 (95% CI −8.2 to 3.5), adjusted for baseline value (<em>p</em> = 0.4). Both results became more pronounced at 12 mo. There was some evidence to suggest that those patients with initial NPI ≥ 15 benefited on neuropsychiatric symptoms from continuing treatment.</p> <h3>Conclusions</h3><p>For most patients with AD, withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status. Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms, but this benefit must be weighed against the side effects of therapy.</p> <p><b>Trial registration:</b> Cochrane Central Registry of Controlled Trials/National Research Register (<a href=\"http://www.controlled-trials.com/ISRCTN33368770/Ballard\">#ISRCTN33368770</a>).</p> </div>", "links"=>[], "tags"=>["placebo-controlled", "dementia", "patients", "stopping", "neuroleptics", "dart-ad"], "article_id"=>153636, "categories"=>["Neuroscience"], "users"=>["Clive Ballard", "Marisa Margallo Lana", "Megan Theodoulou", "Simon Douglas", "Rupert McShane", "Robin Jacoby", "Katja Kossakowski", "Ly-Mee Yu", "Edmund Juszczak"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0050076", "stats"=>{"downloads"=>1, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/A_Randomised_Blinded_Placebo_Controlled_Trial_in_Dementia_Patients__Continuing_or_Stopping_Neuroleptics_The_DART_AD_Trial_/153636", "title"=>"A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients\n Continuing or Stopping Neuroleptics (The DART-AD Trial)", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-04-01 01:00:36"}
  • {"files"=>["https://ndownloader.figshare.com/files/934636"], "description"=>"<p>Change in Total SIB Score (Baseline to 6 Months) by Treatment Group</p>", "links"=>[], "tags"=>["sib"], "article_id"=>605082, "categories"=>["Neuroscience"], "users"=>["Clive Ballard", "Marisa Margallo Lana", "Megan Theodoulou", "Simon Douglas", "Rupert McShane", "Robin Jacoby", "Katja Kossakowski", "Ly-Mee Yu", "Edmund Juszczak"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0050076.g002", "stats"=>{"downloads"=>0, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Change_in_Total_SIB_Score_Baseline_to_6_Months_by_Treatment_Group_/605082", "title"=>"Change in Total SIB Score (Baseline to 6 Months) by Treatment Group", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2008-04-01 01:24:42"}
  • {"files"=>["https://ndownloader.figshare.com/files/934933"], "description"=>"<p>Subgroup Analysis (Change in SIB from Baseline to 6 Months)</p>", "links"=>[], "tags"=>["sib", "baseline"], "article_id"=>605383, "categories"=>["Neuroscience"], "users"=>["Clive Ballard", "Marisa Margallo Lana", "Megan Theodoulou", "Simon Douglas", "Rupert McShane", "Robin Jacoby", "Katja Kossakowski", "Ly-Mee Yu", "Edmund Juszczak"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0050076.g004", "stats"=>{"downloads"=>2, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Subgroup_Analysis_Change_in_SIB_from_Baseline_to_6_Months_/605383", "title"=>"Subgroup Analysis (Change in SIB from Baseline to 6 Months)", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2008-04-01 01:29:43"}

PMC Usage Stats | Further Information

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Relative Metric

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