Identifying Better Outcome Measures to Improve Treatment of Agitation in Dementia: A Report from the EU/US/CTAD Task Force (original) (raw)
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International Psychogeriatrics
ABSTRACTObjectives:More than 90% of individuals with Alzheimer’s disease (AD) experience behavioral and neuropsychiatric symptoms (NPS), such as agitation. However, little is known regarding the specific burden of agitation for Alzheimer’s patients.Design:A global systematic literature review was conducted in MEDLINE and Embase for studies of clinical, humanistic, and economic burden of agitation in AD/dementia published from 2006–2016. References of identified papers and related literature reviews were examined. Studies meeting predetermined inclusion criteria for burden of agitation/NPS were summarized.Results:Eighty papers met the inclusion criteria for burden of agitation in dementia. Wide ranges of agitation prevalence were reported, but few papers provided information on incidence. The association of agitation with AD severity was presented in multiple studies; a few suggested positive association of agitation with mortality.Conclusions:High prevalence of agitation is consiste...
JPAD, 2015
BACKGROUND The management of neuropsychiatric symptoms (NPS) such as agitation and aggression is a major priority in caring for people with Alzheimer's disease (AD). Agitation and aggression (A/A) are among the most disruptive symptoms, and given their impact, they are increasingly an important target for development of effective treatments. Considerable progress has been made in the last years with a growing number of randomized controlled trials (RCTs) of drugs for NPS. The limited benefits reported in some RCTs may be accounted for by the absence of a biological link of the tested molecule to NPS and also by key methodological issues. In recent RCTs of A/A, a great heterogeneity design was found. Designing trials for dementia populations with NPS presents many challenges, including identification of appropriate participants for such trials, engagement and compliance of patients and caregivers in the trials and the choice of optimal outcome measures to demonstrate treatment effectiveness. The EU/US-CTAD Task Force, an international collaboration of investigators from academia, industry, non-profit foundations, and regulatory agencies met in Philadelphia on November 19, 2014 to address some of these challenges. Despite potential heterogeneity in clinical manifestations and neurobiology, agitation and aggression seems to be accepted as an entity for drug development. The field appears to be reaching a consensus in using both agitation and aggression (or other NPS)-specific quantitative measures plus a global rating of change for agitation outcomes based on clinician judgment as the main outcomes.
The Impact of Agitation in Dementia on Caregivers: A Real-World Survey
Journal of Alzheimer's Disease
Background: Dementia patients frequently depend on caregivers. Agitation is a common behavioral dementia symptom particularly burdensome to patients and caregivers. Objective: To assess the association of agitation severity with non-professional caregiver hours, burden, health status, and productivity. Secondarily, to assess the association of agitation severity with these outcomes for patients receiving remote (not living with the patient) and proximate (living with the patient) caregiving. Methods: A retrospective analysis of physician and non-professional caregiver-reported data from a US point-in-time survey. Patients were aged ≥50 years, with early cognitive impairment or dementia. Regression analyses compared outcomes by agitation severity; covariates included age, sex, and clinical characteristics. Results: Data were included for 1,349 patients (non-agitated n = 656, agitated n = 693; no care n = 305, remote care n = 248, proximate care n = 691; unknown care n = 105). Greater...
Journal of the American Medical Directors Association, 2013
Objective: To test the effect of a complex guideline-based intervention on agitation and psychotropic prescriptions. Design, Setting, Participants: Cluster randomized controlled trial (VIDEANT) with blinded assessment of outcome in 18 nursing homes in Berlin, Germany, comprising 304 dementia patients. Intervention: Training, support, and activity therapy intervention, delivered at the level of each nursing home, focusing on the management of agitation in dementia. Control group nursing homes received treatment as usual. Measurements: Levels of agitated and disruptive behavior (Cohen-Mansfield agitation inventory [CMAI]) as the primary outcome. Number of neuroleptics, antidepressants, and cholinesterase inhibitors (ChEIs) prescribed in defined daily dosages (DDDs). Results: Of 326 patients screened, 304 (93.3%) were eligible and cluster-randomized to 9 intervention (n ¼ 163) and 9 control (n ¼ 141) nursing homes. Data were collected from 287 (94.4%) patients at 10 months. At 10 months, compared with controls, nursing home residents with dementia in the intervention group exhibited significantly less agitation as measured with the CMAI (adjusted mean difference, 6.24; 95% CI 2.03e14.14; P ¼ .009; Cohen's d ¼ 0.43), received fewer neuroleptics (P < .05), more ChEIs (P < .05), and more antidepressants (P < .05). Conclusion: Complex guideline-based interventions are effective in reducing agitated and disruptive behavior in nursing home residents with dementia. At the same time, increased prescription of ChEIs and antidepressants together with decreased neuroleptic prescription suggests an effect toward guidelinebased pharmacotherapy.
British journal of clinical pharmacology, 2018
To determine the most efficacious and acceptable treatments of agitation in dementia. MEDLINE, EMBASE, PsycINFO, CENTRAL and clinicaltrials.gov were searched up to 7 February 2017. Two independent reviewers selected randomized controlled trials (RCTs) of treatments to alleviate agitation in people with all-types dementia. Data were extracted using standardized forms and study quality was assessed using the revised Cochrane Risk of Bias Tool for RCTs. Data were pooled using meta-analysis. The primary outcome, efficacy, was 8-week response rates defined as a 50% reduction in baseline agitation score. The secondary outcome was treatment acceptability defined as treatment continuation for 8 weeks. Thirty-six RCTs comprising 5585 participants (30.9% male; mean ± standard deviation age, 81.8 ± 4.9 years) were included. Dextromethorphan/quinidine [odds ratio (OR) 3.04; 95% confidence interval (CI), 1.63-5.66], risperidone (OR 1.96; 95% CI, 1.49-2.59) and selective serotonin reuptake inhibi...
Journal of Alzheimer's Disease
Background: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). Objective: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. Methods: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. Results: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%)...
A new scale for assessing behavioral agitation in dementia
Psychiatry Research, 1992
The primary purpose of the present study was to develop a reliable and valid rating instrument for assessing treatment efficacy for behavioral problems in the cognitively impaired elderly. The Behavioral and Emotional Activities Manifested in Dementia (BEAM-D) Scale was developed for the operational assessment of troublesome and disruptive behaviors in dementia. Each behavioral category of the BEAM-D was clinically considered to be a significant deviation from normative behavior for the geriatric dementia patient. The reliability and validity of the BEAM-D was assessed in a group of 45 patients diagnosed with primary degenerative dementia. The mean interrater reliability of BEAM-D items was 0.90. Concurrent validity was established by comparison with currently used rating scales, the Brief Psychiatric Rating Scale (BPRS) and the Sandoz Clinical Assessment-Geriatric (SCAG). Stepwise regression analysis revealed that the items of the BEAM-D had a strong relationship with conceptually similar behavioral dimensions on the BPRS and SCAG.
The Journal of Clinical Psychiatry, 2014
Objective: Research is needed to determine specific factors that contribute to the success of nonpharmacologic interventions. In this study, we examined the influence of personal characteristics (demographic, medical, and functional variables) and possible barriers (eg, staff or family barriers) on the efficacy of nonpharmacological interventions in reducing agitation. Method: Agitation was systematically observed at baseline and intervention stages using the Agitation Behavior Mapping Instrument (ABMI) in a sample of 89 residents from 6 Maryland nursing homes (mean age = 85.9 years). Each participant received interventions based on an individualized algorithm (TREA-Treatment Routes for Exploring Agitation), which identifies unmet needs and matches interventions to needs and to the participant's sensory, cognitive, and functional abilities, as well as to self-identity and preferences. The study was conducted between June 2006 and December 2011. Results: Analyses revealed that decreased levels of agitation during intervention correlated significantly with higher levels of cognitive function (r = 0.36, P < .001), with fewer difficulties in the performance of activities of daily living (r = 0.29, P < .01), speech (r = 0.47, P < .001), communication (r = 0.23, P < .05), and responsiveness (r = 0.28, P < .01). In addition, less reduction of agitation during intervention was significantly related to the presence of staff barriers (eg, refusals, interruptions) (r = −0.38, P < .001) and the occurrence of pain (r = −0.21, P ≤ .05). Conclusions: The findings elucidate the characteristics of those who are most likely to respond to TREA intervention, and point to the need of systemic changes to reduce staffrelated barriers and to improve methodologies for increasing the impact of intervention on those at the lowest levels of functioning.
The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry, 2013
The aim of this study is to compare the Empirical Behavioral Rating Scale (E-BEHAVE-AD), Neurobehavioral Rating Scale (NBRS), and Neuropsychiatric Interview (NPI) in detecting behavioral disturbance and psychotic symptoms in dementia and characterizing changes in response to treatment. Eighty-seven subjects in the randomized controlled trial "Continuation Pharmacotherapy for Agitation of Dementia" were included in this analysis. We compared the detection in, and changes of, both agitation and psychosis, using these three instruments. A receiver operating characteristic analysis was performed to compare the performance of the three instruments in detecting global improvement. The instruments were equally likely to detect agitation. The NBRS was most likely to detect psychosis. Although the NPI best detected improvement in agitation, the instruments were equal for detecting improvement in psychosis. In the receiver operating characteristic analysis for overall clinical impro...