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Reference: Clive Ballard, Marisa Margallo Lana, Megan Theodoulou et al., (2008). A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (The DART-AD Trial). PLoS Medicine, 5 (4), Article: e76.Citable link to this page:

 

A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (The DART-AD Trial)

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.

Publication status:PublishedPeer Review status:Peer reviewedVersion:Publisher's versionNotes:Citation: Ballard, C. et al. (2008). 'A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (The DART-AD Trial)', PLoS Medicine, 5(4), e76. [Available at http://medicine.plosjournals.org]. © 2008 Ballard et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Bibliographic Details

Publisher: Public Library of Science

Publisher Website: http://www.plos.org/

Host: PLoS Medicinesee more from them

Publication Website: http://medicine.plosjournals.org/

Issue Date: 2008-April

Copyright Date: 2008

pages:Article: e76Identifiers

Doi: https://doi.org/10.1371/journal.pmed.0050076

Issn: 1549-1277

Eissn: 1549-1676

Urn: uuid:f699950a-83dd-48ff-909d-9ee71ac69010 Item Description

Type: Article: post-print;

Language: en

Version: Publisher's versionKeywords: dementia neuroleptics Alzheimer disease cognitive decline neuropsychiatric symptomsSubjects: Medical sciences Psychiatry Old Age psychiatry Statistics (see also social sciences) Tiny URL: ora:2506

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Author: Clive Ballard - institutionKing's College London, London, UK facultyWolfson Centre for Age-Related Diseases fundingAlzheimer&

Source: https://ora.ox.ac.uk/objects/uuid:f699950a-83dd-48ff-909d-9ee71ac69010



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