Elderly Patients With Dementia-Related Symptoms of Severe Agitation and Aggression

Salzman, Carl; Jeste, Dilip V.; Meyer, Roger E.; Cohen‐Mansfield, Jiska; Cummings, Jeffrey L.; Grossberg, George T.; Jarvik, Lissy F.; Kraemer, Helena C.; Lebowitz, Barry D.; Maslow, Katie; Pollock, Bruce G.; Raskind, Murray A.; Schultz, Susan K.; Wang, Philip; Zito, Julie Magno; Zubenko, George S.

doi:10.4088/jcp.v69n0602

Cited by 203 publications

(49 citation statements)

References 38 publications

(37 reference statements)

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“…Among subjects studied, there was a wide degree of variation in type and severity of symptomatology. The clinical trials endpoints were based on behavior rating scales, including the Brief Psychiatric Rating Scale (BPRS), the Behavior Pathology in Alzheimer’s Disease Rating Scale (BEHAVE-AD), the Neuropsychiatric Inventory (NPI), the Cohen-Mansfield Agitation Inventory (CMAI) and subscales (proxy-based more common than direct observation), and global assessments (Salzman et al, 2008). A non-pharmacologic intervention before enrolling a patient in a clinical trial and a placebo run-in period were not common.…”

Section: Introductionmentioning

confidence: 99%

“…We hypothesized that a great heterogeneity in the design of recent RCTs of drugs for A/A in AD would be found and that specific key methodological issues could be identified. Thus, the objective on this paper was to review methodological aspects from recent RCTs of drugs for A/A in AD since 2008; the date of the most recent consensus statement on clinical trials methodology of treatments for A/A in dementia (Salzman et al, 2008). …”

Section: Introductionmentioning

confidence: 99%

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Medication development for agitation and aggression in Alzheimer disease: review and discussion of recent randomized clinical trial design

Soto

Andrieu

Nourhashémi

et al. 2014

Int. Psychogeriatr.

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Background The management of disruptive neuropsychiatric symptom (NPS) such as agitation and aggression (A/A) is a major priority in caring for people with Alzheimer’s disease (AD). Few effective pharmacological or non-pharmacological options are available. Results of randomized clinical trials (RCTs) of drugs for A/A have been disappointing. This may result from the absence of biological efficacy for medications tested in treating A/A. It may also be related to methodological issues such as the choice of outcomes. The aim of this review was to highlight key methodological issues pertaining to RCTs of current and emerging medications for the treatment of A/A in AD. Methods We searched PubMed/Medline, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for RCTs comparing medications with either placebo or other drugs in the treatment of A/A in AD, between January 2008 and December 2013. Results We identified a total of 18 RCTs; of these, 11 were completed and 7 ongoing. Of the ongoing RCTs, only one is in Phase III. Seven of 10 completed RCTs with reported results did not report greater benefit from drug than placebo. Each of the completed RCTs used a different definition of “clinically significant A/A”. There was considerable heterogeneity in study desin. The primary endpoints were largely proxy-based but a variety of scales were used. The definition of caregiver and scales used to assess caregiver outcomes were similarly heterogeneous. Placebo response was notable in all trials. Conclusions This review highlights a great heterogeneity in RCTs design of drugs for A/A in AD and some key methodological issues such as definition of A/A, choice of outcome measures and caregiver participation that could be addressed by an expert consensus to optimize future trials design.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Medication development for agitation and aggression in Alzheimer disease: review and discussion of recent randomized clinical trial design

Soto

Andrieu

Nourhashémi

et al. 2014

Int. Psychogeriatr.

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“…Additionally, many common behaviors that are troublesome to families (refusal of care, repetitive vocalizations, argumentation) do not respond to pharmacological treatments. For these reasons, recent consensus reports recommend nonpharmacologic approaches as the initial treatment modality 7,8 .…”

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confidence: 99%

Assistive devices caregivers use and find helpful to manage problem behaviors of dementia

Gitlin¹,

Winter²,

Dennis³

2010

Gerontechnology

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Purpose Use of assistive devices in caring for individuals with dementia has not been systematically examined, particularly as it concerns managing behavioral symptoms. We tested a nonpharmacologic intervention to manage behaviors that involved instructing families in effective communication techniques, simplifying tasks and the home environment and using assistive devices. This paper describes the assistive devices provided to families assigned to intervention, extent of use of issued devices, their perceived helpfulness, and cost. Design and Methods Following each treatment session, occupational therapists (OT) documented time spent training in the use of strategies to manage problem behaviors. For families receiving assistive devices, OTs asked caregivers after 4 months whether they continued to use the device (yes/no), and extent to which it helped manage the targeted problems (not at all, somewhat, very helpful). We also tracked the costs associated with ordering, delivering and installing devices. Results Of 272 caregiver-patient dyads enrolled in the original trial, 136 were randomized to the intervention group, of whom 63 received one or more assistive devices. Of 13 intervention sessions, an average of 4 (31%) involved discussing or training caregivers in using assistive devices. A total of 197 devices (3 per dyad) were issued of which 87.6% were reported in use at 4 months. Caregivers reported that overall, devices were somewhat to very helpful. Devices ranged in cost from US$4.80 to US$282.93 with an average cost per dyad of US$152.52(SD=US$102.70) which included the device, its ordering, delivery and installation.

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“…Agitation and other NPS are often treated with psychotropic drugs, even though the evidence for an effect is modest and this mode of treatment might cause severe side effects [10]. Non-pharmacological interventions are, therefore, recommended as the initial treatment approach [11,12]. However, Cochrane reviews conclude that there is either a lack of evidence of effect or methodological limitations to studies of non-pharmacological interventions such as music therapy [13], massage and touch [14], validation [15], bright light therapy [16], Snoezelen [17] and aroma therapy [10,18].…”

Section: Introductionmentioning

confidence: 99%

The Effect of Person-Centred Dementia Care to Prevent Agitation and Other Neuropsychiatric Symptoms and Enhance Quality of Life in Nursing Home Patients: A 10-Month Randomized Controlled Trial

Rokstad

Røsvik

Kirkevold³

et al. 2013

Dement Geriatr Cogn Disord

104

147

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Aims: We examined whether Dementia Care Mapping (DCM) or the VIPS practice model (VPM) is more effective than education of the nursing home staff about dementia (control group) in reducing agitation and other neuropsychiatric symptoms as well as in enhancing the quality of life among nursing home patients. Methods: A 10-month three-armed cluster-randomized controlled trial compared DCM and VPM with control. Of 624 nursing home patients with dementia, 446 completed follow-up assessments. The primary outcome was the change on the Brief Agitation Rating Scale (BARS). Secondary outcomes were changes on the 10-item version of the Neuropsychiatric Inventory Questionnaire (NPI-Q), the Cornell Scale for Depression in Dementia (CSDD) and the Quality of Life in Late-Stage Dementia (QUALID) scale. Results: Changes in the BARS score did not differ significantly between the DCM and the control group or between the VPM and the control group after 10 months. Positive differences were found for changes in the secondary outcomes: the NPI-Q sum score as well as the subscales NPI-Q agitation and NPI-Q psychosis were in favour of both interventions versus control, the QUALID score was in favour of DCM versus control and the CSDD score was in favour of VPM versus control. Conclusions: This study failed to find a significant effect of both interventions on the primary outcome. Positive effects on the secondary outcomes indicate that the methods merit further investigation.

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Elderly Patients With Dementia-Related Symptoms of Severe Agitation and Aggression

Abstract: This article outlines methodological enhancements to better evaluate treatment approaches in future registration trials and provides an algorithm for improving the treatment of these patients in nursing home and non-nursing home settings.

Cited by 203 publications

References 38 publications

Medication development for agitation and aggression in Alzheimer disease: review and discussion of recent randomized clinical trial design

Medication development for agitation and aggression in Alzheimer disease: review and discussion of recent randomized clinical trial design

Assistive devices caregivers use and find helpful to manage problem behaviors of dementia

The Effect of Person-Centred Dementia Care to Prevent Agitation and Other Neuropsychiatric Symptoms and Enhance Quality of Life in Nursing Home Patients: A 10-Month Randomized Controlled Trial

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