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Study Objectives: We investigated the effectiveness of a lighting intervention tailored to maximally affect the circadian system as a nonpharmacological therapy for treating problems with sleep, mood, and behavior in persons with Alzheimer disease and related dementias (ADRD). Methods: This 14-week randomized, placebo-controlled, crossover design clinical trial administered an all-day active or control lighting intervention to 46 patients with ADRD in 8 long-term care facilities for two 4-week periods (separated by a 4-week washout). The study employed wrist-worn actigraphy measures and standardized measures of sleep quality, mood, and behavior. Results: The active intervention significantly improved Pittsburgh Sleep Quality Index scores compared to the active baseline and control intervention (mean ± SEM: 6.67 ± 0.48 after active intervention, 10.30 ± 0.40 at active baseline, 8.41 ± 0.47 after control intervention). The active intervention also resulted in significantly greater active versus control differences in intradaily variability. As for secondary outcomes, the active intervention resulted in significant improvements in Cornell Scale for Depression in Dementia scores (mean ± SEM: 10.30 ± 1.02 at baseline, 7.05 ± 0.67 after active intervention) and significantly greater active versus control differences in Cohen-Mansfield Agitation Inventory scores (mean ± SEM: −5.51 ± 1.03 for the active intervention, −1.50 ± 1.24 for the control intervention). Conclusions: A lighting intervention tailored to maximally entrain the circadian system can improve sleep, mood, and behavior in patients with dementia living in controlled environments. Clinical Trial Registration: Registry: ClinicalTrials.gov , title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia, URL: https://clinicaltrials.gov/ct2/show/NCT01816152 , identifier: NCT01816152. Citation: Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a tailored lighting intervention on sleep quality, rest–activity, mood, and behavior in older adults with Alzheimer disease and related dementias: a randomized clinical trial. J Clin Sleep Med . 2019;15(12):1757–1767.

In a study of patients with Alzheimer's disease and associated psychosis or agitation that had responded to risperidone, the risk of relapse was greater among patients randomly assigned to switch to placebo than among those who continued to receive risperidone. Symptoms of psychosis or agitation are common in Alzheimer's disease. 1 , 2 These symptoms are associated with distress on the part of the patient, an increased burden on caregivers, more rapid cognitive decline, an increased likelihood of institutionalization, and increased health care costs. 3 Nonpharmacologic behavioral treatment approaches may help, 4 – 9 but large, controlled trials are needed to confirm the effectiveness of these strategies. Among psychotropic medications, only antipsychotic agents show superiority over placebo for the treatment of psychosis and agitation–aggression in patients with dementia, although they are associated with only low-to-moderate efficacy. 10 – 12 Side effects of antipsychotic drugs include sedation, extrapyramidal . . .

ABSTRACTObjectivesOne-on-one structured Montessori-based activities conducted with people with dementia can improve agitation and enhance engagement. These activities may however not always be implemented by nursing home staff. Family members may present an untapped resource for enabling these activities. This study aimed to evaluate the impact of the Montessori activities implemented by family members on visitation experiences with people who have dementia. DesignCluster-randomized crossover design. SettingGeneral and psychogeriatric nursing homes in the state of Victoria, Australia. ParticipantsForty participants (20 residents and 20 carers) were recruited. InterventionDuring visits, family members interacted with their relative either through engaging in Montessori-based activities or reading a newspaper (the control condition) for four 30-minute sessions over 2 weeks. MeasurementsResidents’ predominant affect and engagement were rated for each 30-second interval using the Philadelphia Geriatric Center Affect Rating Scale and the Menorah Park Engagement Scale. The Pearlin Mastery Scale was used to rate carers satisfaction with visits. The 15-item Mutuality Scale measured the carers quality of their relationship with the resident. Carers’ mood and overall quality of life were measured using the Center for Epidemiological Studies Depression Scale and Carer-QoL questionnaires, respectively. ResultsLinear regressions within the generalized estimating equations approach assessed residents’ and carers’ outcomes. Relative to the control condition, the Montessori condition resulted in more positive engagement ( b = 13.0, 95%CI 6.3–19.7, p < 0.001) and affect ( b = 0.4, 95%CI 0.2–0.6, p < 0.001) for the residents and higher satisfaction with visits for carers ( b = 1.7, 95%CI 0.45–3.00, p = 0.008). No correction was applied to p-values for multiple comparisons. ConclusionThis study strengthens the evidence base for the use of the Montessori programs in increasing well-being in nursing home residents. The findings also provide evidence that family members are an additional valuable resource in implementing structured activities such as the Montessori program with residents.

Background: Increasingly more attention has been paid to non-pharmacological interventions as treatment of agitated behaviors that accompany dementia. The aim of the current study is to test if personalized one-to-one interaction activities based on Montessori principles will improve agitation, affect, and engagement more than a relevant control condition. Methods: We conducted a randomized crossover trial in nine residential facilities in metropolitan Melbourne, Australia (n = 44). Personalized one-to-one activities that were delivered using Montessori principles were compared with a non-personalized activity to control for the non-specific benefits of one-to-one interaction. Participants were observed 30 minutes before, during, and after the sessions. The presence or absence of a selected physically non-aggressive behavior was noted in every minute, together with the predominant type of affect and engagement. Results: Behavior counts fell considerably during both the Montessori and control sessions relative to beforehand. During Montessori activities, the amount of time spend actively engaged was double compared to during the control condition and participants displayed more positive affect and interest as well. Participants with no fluency in English (all from non-English speaking backgrounds) showed a significantly larger reduction in agitation during the Montessori than control sessions. Conclusion: Our results show that even non-personalized social contact can assist in settling agitated residents. Tailoring activities to residents’ needs and capabilities elicit more positive interactions and are especially suitable for people who have lost fluency in the language spoken predominantly in their residential facility. Future studies could explore implementation by family members and volunteers to avoid demands on facilities’ resources. Trial Registration: Australian New Zealand Clinical Trials Registry – ACTRN12609000564257.

A Food and Drug Administration (FDA) safety communication in August 2011 warned that citalopram was associated with a dose dependent risk of QT prolongation and recommended dose restriction in patients over the age of 60 but did not provide data for this age group. CitAD was a randomized, double-masked, placebo-controlled, multicenter clinical trial for agitation in Alzheimer's disease (AD). Participants were assigned to citalopram (target dose of 30 mg/day) or placebo in a 1 ∶ 1 ratio. 186 people, 181 of whom were over the age of 60, having probable AD with clinically significant agitation were recruited from September 2009 to January 2013. After the FDA safety communication about citalopram, ECG was added to the required study procedures before enrollment and repeated at week 3 to monitor change in QTc interval. Forty-eight participants were enrolled after enhanced monitoring began. Citalopram treatment was associated with a larger increase in QTc interval than placebo (difference in week 3 QTc adjusting for baseline QTc: 18.1 ms [95% CI: 6.1, 30.1]; p = 0.004). More participants in the citalopram group had an increase ≥ 30 ms from baseline to week 3 (7 in citalopram versus 1 in placebo; Fisher's exact p = 0.046), but only slightly more in the citalopram group met a gender-specific threshold for prolonged QTc (450 ms for males; 470 ms for females) at any point during follow-up (3 in citalopram versus 1 in placebo, Fisher's exact p = 0.611). One of the citalopram participants who developed prolonged QTc also displayed ventricular bigeminy. No participants in either group had a cardiovascular-related death. Citalopram at 30 mg/day was associated with improvement in agitation in patients with AD but was also associated with QT prolongation. ClinicalTrials.gov NCT00898807.

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 improvement in response to treatment, there were no differences in the areas under the correlated curves for the three instruments, but they demonstrated different sensitivity and specificity at different cutoff points for target symptom reduction. The E-BEHAVE-AD performed best at a cut point of 30% target symptom reduction and the NBRS and NPI both performed best at 50%. The E-BEHAVE-AD, NBRS, and NPI were more similar than different in characterizing symptoms but differed in detecting response to treatment. Differences in sensitivity and specificity may lead clinicians to prefer a specific instrument, depending on their goal and the expected magnitude of response to any specific intervention.

Agitation/aggressive behaviour is a common behavioural and psychological symptom in people with dementia (PwD), occurring with a frequency of between 13-50.4% according to recent studies, and the rate increases as the severity of cognitive decline increases. The burden on caregivers is considerable. This trial is a randomized controlled crossover trial conducted in Greece. The following measures were used: the Mini-Mental State Examination, Addenbrooke's Cognitive Examination Revised, Geriatric Depression Scale, Functional Rating Scale for Symptoms in Dementia and Neuropsychiatric Inventory. According to the results the most effective nonpharmacological intervention for reducing agitation/aggressive behaviour in PwD was music therapy, followed by aromatherapy and massage, and finally physical exercise.

This double-blind, placebo-controlled study investigated the efficacy and safety of intramuscular (IM) aripiprazole and IM haloperidol for the treatment of acute agitation in patients with schizophrenia or schizoaffective disorder. Four-hundred and forty-eight patients were randomized (2:2:1 ratio) to IM aripiprazole 9.75 mg, IM haloperidol 6.5 mg, or IM placebo. Patients could receive up to three injections over the first 24 h, with second and third injections administered > or =2 and > or =4 h, respectively, after the first if deemed clinically necessary. Primary efficacy measure was mean change in Positive and Negative Syndrome Scale Excited Component (PEC) score from baseline to 2 h. Mean improvement in PEC at 2 h was significantly greater for IM aripiprazole (-7.27) vs placebo (-4.78; p<0.001); IM aripiprazole was noninferior to IM haloperidol (-7.75) on PEC. All secondary efficacy measures showed significantly greater improvements at 2 h for IM aripiprazole and IM haloperidol over placebo. Mean number of injections/patient and percentage of patients requiring benzodiazepines were significantly lower for IM aripiprazole vs placebo (p<0.01). IM aripiprazole was well tolerated. Extrapyramidal symptom-related adverse events were similar for aripiprazole (1.7%) and placebo (2.3%) and lower than with haloperidol (12.6%). These results show that IM aripiprazole is an effective treatment, comparable to IM haloperidol, and well-tolerated for acute agitation in patients with schizophrenia.

Background The management of acute agitation manifesting in patients with schizophrenia or bipolar disorder requires swift pharmacological intervention to provide rapid symptomatic relief and prevent escalation to aggression and violence. Antipsychotic medications are widely used in this setting and the availability of an inhaled formulation with deep lung absorption of the antipsychotic loxapine has the potential to deliver a faster onset of therapeutic effect than the available intramuscular formulations of antipsychotics. Methods The efficacy of inhaled loxapine and the alternative antipsychotic aripiprazole delivered via intramuscular (IM) injection will be compared in the Phase IIIb PLACID study. Adults (18–65 years) with a confirmed diagnosis of schizophrenia or bipolar I disorder presenting with acute agitation will be randomly assigned to open-label treatment in a 1:1 ratio. Clinical evaluation will be conducted by raters blinded to treatment assignment. The primary efficacy endpoint is time to response (defined as a Clinical Global Impression of Improvement [CGI-I] score of 1 [very much improved] or 2 [much improved]). Secondary endpoints will include the percentage of responders at different time points after dosing; the proportion of patients who receive 1 or 2 doses of study drug; time to second dose; time to rescue medication; satisfaction with study drug (evaluated using Item 14 of the Treatment Satisfaction Questionnaire for Medication); and safety and tolerability. Approximately 360 patients will be recruited with an interim analysis conducted once 180 patients have completed the study to decide whether to stop for futility or continue with or without an increase in the sample size up to additional 288 patients. Discussion The PLACID trial will assess the efficacy and safety of inhaled loxapine with deep lung absorption compared with the IM antipsychotic, aripiprazole, in acutely agitated patients with schizophrenia or bipolar disorder. In the event that the median time to response of inhaled loxapine is significantly shorter than that of the intramuscular aripiprazole, the PLACID study has the potential to support the inhaled antipsychotic therapy as the standard of care in this setting. Trial registration The study protocol was registered with the European Clinical Trials Database on the 31 October 2014 (EudraCT number 2014–000456-29 ).

Preliminary data suggest that morning bright light might improve symptoms of agitation, a serious problem in patients with dementia. The authors expand on an earlier pilot study by evaluating the effect of bright light therapy on agitated behavior in a large sample of patients with severe dementia. Ninety-two patients were randomly assigned to morning bright light, morning dim red light, or evening bright light. Agitation was rated by research staff who observed the patients every 15 minutes throughout the treatment period and by caregivers at one time-point before and one time-point after treatment. Morning bright light delayed the acrophase of the agitation rhythm by over 1.5 hours. Bright light was associated with improved caregivers' ratings but had little effect on observational ratings of agitation. Although the result that light shifted the peak of the agitated behavior might be generalizable to patients with milder forms of AD, the fact that agitation was not ameliorated might not be. Because the suprachiasmatic nucleus (SCN) of patients with severe AD is likely to be more degenerated, and the circadian activity rhythms deteriorate as the disease progresses, it is still possible that patients with more intact SCNs, that is, patients with mild or moderate AD, might benefit from light treatment even more than those with severe AD.