A double-blind randomised comparison of risperidone and haloperidol in the treatment of behavioural and psychological symptoms in Chinese dementia patients.

BACKGROUND: Behavioural and psychological symptoms (BPSD) are common during the course of dementia and present severe problems to patients and their caregivers. OBJECTIVES: To assess the therapeutic efficacy and safety of haloperidol and risperidone in treating BPSD in Chinese dementia patients. METHODS: A 12-week double-blind randomised comparison of haloperidol and risperidone treatments was conducted in 58 patients with DSM-IV diagnosis of dementia of Alzheimer's type or vascular dementia. They were randomly assigned to receive flexible doses (0.5 to 2 mg/day) of haloperidol or risperidone. Clinical response was evaluated using the Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), Simpson-Angus Scale, Functional Assessment Staging and Cantonese version of the Mini-Mental State Examination. RESULTS: The mean doses at the last week were 0.90 mg/day of haloperidol and 0.85 mg/day of risperidone. Both haloperidol and risperidone significantly reduced the severity of BPSD (scores on CMAI and BEHAVE-AD), with no significant between-group differences. Haloperidol-treated patients showed a worsening on Simpson-Angus scale while there was no significant change in this measure in risperidone-treated patients. CONCLUSIONS: Low-dose haloperidol and risperidone were well tolerated and associated with reductions in the severity and frequency of behavioural symptoms in subjects with dementia. Risperidone may have a more favourable risk-benefit profile in view of its lower propensity to induce extrapyramidal symptoms.     

A randomized placebo-controlled trial of risperidone for the treatment of aggression,agitation, and psychosis of dementia

BACKGROUND: This randomized, double-blind, placebo-controlled trial examined the efficacy and safety of risperidone in the treatment of aggression, agitation, and psychosis in elderly nursing-home patients with dementia. METHOD: Elderly patients with a DSM-IV diagnosis of dementia of the Alzheimer's type, vascular dementia, or a combination of the 2 (i.e., mixed dementia) and significant aggressive behaviors were randomized to receive, for a period of 12 weeks, a flexible dose of either placebo or risperidone solution up to a maximum of 2 mg/day. Outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI), the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale, and the Clinical Global Impression of Severity (CGI-S) and of Change (CGI-C) scales. RESULTS: A total of 345 patients were randomized to treatment with risperidone or placebo, and 337 patients received at least one dose of study drug. The trial was completed by 67% of patients in the placebo group and 73% of patients in the risperidone group. The mean +/- SE dose of risperidone was 0.95 +/- 0.03 mg/day. The primary endpoint of the study, the difference from baseline to endpoint in CMAI total aggression score, showed a significant reduction in aggressive behavior for risperidone versus placebo (p <.001). A similar improvement was also seen for the CMAI total non-aggression subscale (p <.002) and for the BEHAVE-AD total (p <.001) and psychotic symptoms subscale (p =.004). At endpoint, the CGI-S and the CGI-C scores indicated a significantly greater improvement with risperidone compared with placebo (p <.001). Overall, 94% and 92% of the risperidone and placebo groups, respectively, reported at least 1 adverse event. Somnolence and urinary tract infection were more common with risperidone treatment, whereas agitation was more common with placebo. There was no significant difference in the number of patients who reported extrapyramidal symptoms between the risperidone (23%) and placebo (16%) groups. CONCLUSION: Treatment with low-dose (mean = 0.95 mg/day) risperidone resulted in significant improvement in aggression, agitation, and psychosis associated with dementia.     

A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia.

OBJECTIVE: To compare effects of risperidone with placebo (efficacy and tolerability) and haloperidol (tolerability) for treating demented patients with aggression and other behavioral symptoms. METHODS: A 13-week double-blind study involving 344 patients with dementia randomly assigned to receive placebo or flexible doses (0.5 to 4 mg/d) of risperidone or haloperidol. Behavioral symptoms were assessed by the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), the Cohen-Mansfield Agitation Inventory (CMAI), and the Clinical Global Impression (CGI) scale. Tolerability assessments included the Extrapyramidal Symptom Rating Scale, sedation levels, Functional Assessment Staging, Mini-Mental State Examination, and incidence of adverse events. RESULTS: The mean dose at endpoint was 1.1 mg/d of risperidone and 1.2 mg/d of haloperidol. Although not significant, a higher percentage of patients receiving risperidone than those receiving placebo showed clinical improvement (> or =30% reduction from baseline to endpoint in BEHAVE-AD total score) at endpoint and week 12. Reductions in the BEHAVE-AD total score were significantly greater with risperidone than with placebo at week 12. In a further analysis of aggression, the most dominant symptom in these patients, BEHAVE-AD and CMAI aggression cluster scores were significantly reduced compared with placebo at endpoint and week 12. CGI scores were also significantly reduced at endpoint and week 12. Severity of extrapyramidal symptoms with risperidone did not differ significantly from that of placebo and was less than that of haloperidol. A post hoc analysis showed significantly greater reductions in the BEHAVE-AD aggressiveness score with risperidone than haloperidol at week 12. CONCLUSION: Low-dose risperidone (mean 1.1 mg/d) was well tolerated and associated with reductions in the severity and frequency of behavioral symptoms, particularly aggression, in elderly patients with dementia.     

The efficacy and safety of risperidone in the treatment of psychosis of Alzheimer's disease and mixed dementia: a meta-analysis of 4 placebo-controlled clinical trials

BACKGROUND: Dementia typically includes behavioral and psychological symptoms of dementia (BPSD) as well as cognitive decline. Psychosis of Alzheimer's disease (AD) is a specific component of AD, characterized by delusions, misidentifications, and hallucinations. METHODS: This study is a meta-analysis of patients with psychosis of AD from four large placebo-controlled clinical trials of risperidone in dementia. Three trials included patients diagnosed with heterogeneous symptoms of BPSD (those with psychosis of AD were included in this analysis), while one trial included only those diagnosed with psychosis of AD. Efficacy was measured using the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression (CGI). RESULTS: Primary analyses in the psychosis of AD population demonstrated that risperidone significantly improved scores on the BEHAVE-AD Psychosis subscale and CGI scale compared with placebo. Secondary analyses demonstrated that patients with more severe symptoms showed a more pronounced response to treatment with risperidone compared with placebo than those patients with less severe symptoms. Extrapyramidal symptoms and somnolence were more frequent with risperidone than placebo (p=0.04). Cerebrovascular adverse events and all-cause mortality were observed more frequently, although not statistically significantly, with risperidone versus placebo. CONCLUSIONS: This meta-analysis of psychosis of AD showed improvement in psychotic symptoms and general clinical improvement in patients with psychosis of AD treated with risperidone compared with placebo. The benefits of treatment were most significant in patients with severe symptoms. The safety profile of risperidone in this psychosis of AD population was similar to the more general BPSD population.     

Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group

BACKGROUND: We report the findings from the first large, double-blind, placebo-controlled study conducted to evaluate the efficacy and safety of risperidone in the treatment of psychotic and behavioral symptoms in institutionalized elderly patients with dementia. METHOD: 625 patients (67.8% women; mean age = 82.7 years) with DSM-IV diagnoses of Alzheimer's disease (73%), vascular dementia (15%), or mixed dementia (12%) and significant psychotic and behavioral symptoms were included. Each patient was randomly assigned to receive placebo or 0.5 mg/day, 1 mg/day, or 2 mg/day of risperidone for 12 weeks. The primary outcome measure was the Behavioral Pathology in Alzheimer's Disease rating scale (BEHAVE-AD). RESULTS: The study was completed by 70% of the patients. Baseline Functional Assessment Staging scores were 6 or 7 in more than 95% of the patients, indicating severe dementia. At endpoint, significantly greater reductions in BEHAVE-AD total scores and psychosis and aggressiveness subscale scores were seen in patients receiving 1 and 2 mg/day of risperidone than in placebo patients (p = .005 and p < .001, respectively). At week 12, 0.5 mg/day of risperidone was superior to placebo in reducing BEHAVE-AD aggression scores (p = .02). More adverse events were reported by patients receiving 2 mg/day of risperidone than 1 mg/day. The most common dose-related adverse events were extrapyramidal symptoms, somnolence, and mild peripheral edema. The frequency of extrapyramidal symptoms in patients receiving 1 mg/day of risperidone was not significantly greater than in placebo patients. CONCLUSION: Risperidone significantly improved symptoms of psychosis and aggressive behavior in patients with severe dementia. Results show that 1 mg/day of risperidone is an appropriate dose for most elderly patients with dementia.     

Quetiapine treatment for behavioral and psychological symptoms in patients with senile dementia of Alzheimer type

The purpose of this study was to assess the effect of quetiapine in the treatment of behavioral and psychological symptoms of dementia (BPSD) in patients with senile dementia of Alzheimer type (SDAT). Sixteen SDAT patients with BPSD were recruited and quetiapine (25- 200 mg/day) was prescribed for 8 weeks. BPSD were evaluated with the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) and Cohen-Mansfield Agitation Inventory (CMAI) at week 0 (baseline) and week 8 (endpoint). The severity of the extrapyramidal symptoms was also assessed by the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) at baseline and endpoint. Significant improvements were seen in the CMAI total score and in the BEHAVE-AD subscales of delusions, activity disturbances, aggressiveness, diurnal rhythm disturbances and in the BEHAVE-AD overall severity. There was no significant difference between the baseline and endpoint in the DIEPSS score. These data indicate that quetiapine is effective in controlling BPSD with favorable adverse-event profiles.     

Comparative efficacy of risperidone versus haloperidol on behavioural and psychological symptoms of dementia

BACKGROUND: Behavioural and psychological symptoms of dementia (BPSD) cannot be regarded as a single clinical syndrome, but rather as a heterogeneous group of symptoms, each of which can be considered as possible targets for therapy. OBJECTIVE: To compare the efficacy of risperidone and haloperidol on specific manifestations of BPSD. METHODS: A post-hoc analysis was conducted using data from an 18-week, randomized, double-blind, crossover head-to-head trial of risperidone vs haloperidol in treating 114 nursing-home residents with BPSD. Dependent variables were item scores of the Korean versions of the Behavioural Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD-K) and Cohen-Mansfield Agitation Inventory (CMAI-K). RESULTS: On the BEHAVE-AD-K, risperidone was significantly more effective than haloperidol in treating wandering (p = 0.0496), agitation (p = 0.0091), diurnal rhythm disturbances (p = 0.0137), anxiety regarding upcoming events (p = 0.0002), and other anxieties (p = 0.0088). On the CMAI-K, risperidone was significantly more effective in treating physical sexual advances (p = 0.0202), pacing and aimless wandering (p = 0.0123), intentional falling (p = 0.0398), hoarding things (p = 0.0499), performing repetitious mannerisms (p = 0.0048), repetitive sentence or questions (p = 0.0025), complaining (p = 0.0101), and negativism (p = 0.0027). Haloperidol was not significantly superior to risperidone on any individual item in either scale. CONCLUSIONS: When comparing treatment effects on individual symptoms frequently occurring in patients with dementia, risperidone significantly improved symptoms of agitation, wandering, diurnal rhythm disturbance and anxieties, among other symptoms, compared with haloperidol.     

齐拉西酮治疗老年痴呆精神行为障碍对照研究

目的：探讨齐拉西酮和氟哌啶醇对老年期痴呆患者精神行为症状（BPSD）的疗效和安全性。方法：将60例老年期痴呆伴BPSD患者随机分成两组,分别使用齐拉西酮和氟哌啶醇治疗8周,采用痴呆病理行为评定量表（BEHAVE-AD）,激越行为量表（CMAI）及治疗中出现的症状量表（TESS）评定疗效和不良反应。结果：两组治疗前后BEHAVE-AD和CMAI评分显著下降（P〈0.01）,两组患者之间治疗前后BEHAVE-AD总减分值差异无统计学意义（P〉0.05）,但情感障碍和焦虑两因子减分值差异有统计学意义（P〈0.05）。结论：齐拉西酮和氟哌啶醇治疗老年期痴呆患者BPSD的疗效相当,齐拉西酮的优势在于对情感障碍和焦虑的疗效更加明显,锥体外系不良反应轻。     

Prevalence and correlates of disruptive behavior in patients in Norwegian nursing homes

BACKGROUND: Although Behavioral and Psychological Symptoms of Dementia (BPSD) increase with increasing dementia severity, and institutionalization of an individual with dementia is often caused by behavioral symptoms, relatively few studies have explored the prevalence of BPSD in nursing homes. OBJECTIVE: To study the prevalence and correlates of agitation in residents with dementia, in Norwegian nursing homes. METHODS: This study has taken place in dementia wards in four Norwegian nursing homes. To measure agitation in residents with dementia we used the Cohen-Mansfield Agitation Inventory (CMAI), consisting of 29 agitation items. Dementia stage was measured by Functional Assessment Staging (FAST). RESULTS: Two hundred and eleven patients (71% female) were included in the study: mean (SD) age 85.5 (8.4), FAST 4.7 (2.1), CMAI total sumscore 39.5 (12.6). Dementia was present in 167 (79%) subjects. Among those with dementia, weekly occurrence of at least one CMAI item (i.e. a score of 3 or higher) occurred in 75.4% (95% CI 68.4-81.4). Six of the items occurred at least weekly in 20% of the residents with dementia, and 11 of the items, including physical aggression, occurred in less than 5% of the residents. Agitation was associated with more severe dementia (p = 0.001), but not with age and gender. CONCLUSION: Symptoms of agitation were common, but may nevertheless be lower compared to findings in other geographical areas. Further studies are warranted to test this hypothesis, and if confirmed, to explore possible causes for such differences.     

Risperidone in the treatment of psychosis of Alzheimer disease: results from a prospective clinical trial.

OBJECTIVE: The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease (AD). METHOD: The authors conducted a randomized, eight-week, double-blind, placebo-controlled, multicenter trial involving nursing home residents diagnosed with AD and psychosis. Four hundred seventy-three patients were randomly assigned to placebo (N = 238) or 1.0 to 1.5 mg risperidone per day (N = 235). Coprimary efficacy end points were: changes in scores on the Behavioral pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression of Change (CGI-C). Protocol-specified subgroup analyses were performed by demographics and dementia severity. RESULTS: Efficacy analysis included 416 patients. Both groups improved significantly on the BEHAVE-AD Psychosis subscale and CGI-C with no significant difference between groups. In the subgroups analyses, a statistically significant treatment by Mini-Mental Status Examination (MMSE) interaction on the CGI-C (F([2,381]) = 3.90, p = 0.021) was observed with patients with more severe dementia (MMSE <10) showing significant differences at end point favoring risperidone treatment (chi(2) ([1]) = 5.11, p = 0.024). Mean risperidone dose was 1.03 +/- 0.24 mg per day. All-cause discontinuation rates were 25% for both risperidone and placebo. Treatment-emergent adverse events occurred in 74% risperidone versus 64% placebo patients, with somnolence occurring significantly more frequently with risperidone (16.2% versus 4.6%). Nine (3.8%) risperidone- and six (2.5%) placebo patients died during or within 30 days after treatment. CONCLUSION: This trial did not confirm earlier findings in this population.     

Risperidone for psychosis of Alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial

OBJECTIVE: To evaluate the efficacy and safety of low-dose risperidone in treating psychosis of Alzheimer's disease (AD) and mixed dementia (MD) in a subset of nursing-home residents who had dementia and aggression and who were participating in a randomized placebo-controlled trial of risperidone for aggression. METHOD: This post-hoc analysis included only patients diagnosed with AD or MD with psychosis, defined by a score of >or= 2 on any item of the Behavioral Pathology of Alzheimer's Disease (BEHAVE-AD) psychosis subscale at both screening and baseline. Co-primary efficacy endpoints were changes in scores on BEHAVE-AD psychosis subscale and Clinical Global Impression of Change (CGI-C). RESULTS: Overall, 93 patients (46 risperidone and 47 placebo) fulfilled the psychosis of AD criteria. Mean change at endpoint in BEHAVE-AD psychosis subscale with risperidone was superior to placebo (-5.2 vs -3.3; p = 0.039). Distribution of CGI-C at endpoint also favoured risperidone (p < 0.001). The superior improvement with risperidone compared with placebo occurred as early as the first two weeks and persisted to the end of the treatment period. At endpoint, 59% of risperidone-treated patients were responders (i.e. were 'very much' or 'much' improved) compared with 26% of patients receiving placebo. The mean risperidone dose was 1.03 +/- 0.61 mg/day. Twelve weeks of treatment were completed by 37 patients treated with risperidone (80%) and 35 with placebo (74%). A total of 46 (98%) placebo- and 44 (96%) risperidone-treated patients experienced at least one adverse event, with only somnolence occurring more frequently in the risperidone group. CONCLUSION: Risperidone effectively reduces psychosis and improves global functioning in elderly patients with moderate-to-severe psychosis of AD and MD.     

Quetiapine versus risperidone in elderly patients with behavioural and psychological symptoms of dementia: efficacy, safety and cognitive function.

OBJECTIVE: In this study we directly compared the efficacy and tolerability of the atypical antipsychotics quetiapine and risperidone in elderly patients with dementia and symptoms of disturbed perception, thought content, mood or behaviour (behavioural and psychological symptoms of dementia-BPSD). METHODS: We conducted an 8-week, rater-blinded, randomised study of 72 outpatients (55-85 years) with BPSD (assessed by NPI baseline score), who received flexibly-dosed quetiapine (50-400 mg/day) or risperidone (0.5-2 mg/day). Primary efficacy measure: Neuropsychiatric Inventory (NPI) Parts 1 and 2; secondary efficacy measures: Clinical Global Impression (CGI), Cohen-Mansfield Agitation Inventory (CMAI), Mini-Mental State Examination (MMSE), Age-adjusted concentration test (AKT). Safety evaluations included the incidence of extrapyramidal symptoms (EPS) and adverse events (AEs). RESULTS: Sixty-nine of 72 patients were evaluable for efficacy (72 were evaluated for safety), 4 patients discontinued (3 due to AEs: quetiapine 2, risperidone 1; 1 lost to follow-up). Sixty-five patients received quetiapine (n=34; mean dose 77+/-40 mg/day) or risperidone (n=31; mean dose 0.9+/-0.3 mg/day). There was no significant difference between treatments on NPI scores; within treatment groups, NPI scores decreased significantly from baseline to Week 8 (P相似文献   

Management of agitation, aggression, and psychosis associated with dementia: a pooled analysis including three randomized, placebo-controlled double-blind trials in nursing home residents treated with risperidone

This analysis used pooled data from three randomized, placebo-controlled trials that examined the efficacy and safety of risperidone for the treatment of agitation, aggression, and psychosis associated with dementia in elderly nursing home residents to assess the risk-benefit of the use of risperidone in this population.

The efficacy data (risperidone n = 722, placebo n = 428) were obtained from the Cohen-Mansfield agitation inventory (CMAI) and behavioral pathology in Alzheimer's disease (BEHAVE-AD) total and subscales. Additionally, clinical global impression (CGI) assessments were performed. Subgroup analyses were performed by type of dementia, severity of dementia, presence or absence of somnolence as an adverse event, and presence or absence of psychosis at baseline. Safety assessments included evaluation of treatment emergent adverse events, Extrapyramidal Symptom Rating Scale, ECG and vital signs, and Mini-Mental State Examination (MMSE). The mean dose of risperidone at end point was 1.0 mg/day (0.02 S.E.).

The observed mean change at end point was significantly higher for risperidone than for placebo on CMAI total score (−11.8 versus −6.4, respectively; p < 0.001), total aggression score (−5.0 versus −1.8, respectively; p < 0.001), BEHAVE-AD total score (−6.1 and −3.6, respectively; p < 0.001), and psychotic symptoms score (−2.1 and −1.3, respectively; p = 0.003). The main treatment effects of risperidone were similar in all subgroup analyses. Additionally, risperidone-treated patients scored significantly better than placebo-treated patients on the CGI scales at end point.

The incidence of treatment-emergent adverse events was comparable between risperidone (84.3%) and placebo (83.9%). More patients discontinued due to adverse events in the risperidone-treated group (17.2%) than in the placebo group (11.2%). Differences in adverse event incidences between placebo and risperidone were observed for extrapyramidal symptoms (EPS), mild somnolence and the less common cerebrovascular adverse events (CAE). Risperidone induced neither orthostatic, nor anticholinergic side effects nor falls nor cognitive decline.

Of all atypical antipsychotics, risperidone has the largest database of double-blind controlled trials to support its efficacy and safety in the treatment of agitation, aggression, and psychosis associated with dementia. At the recommended doses, risperidone displayed a favorable risk-benefit profile. Risperidone was well tolerated with respect to EPS, somnolence, and anticholinergic side effects in this elderly population. In view of the risk for CAEs, risperidone, should be targeted towards the treatment of those patients in whom psychotic and behavioral symptoms of dementia are prominent and associated with significant distress, functional impairment or danger to the patient.     

Clinical experience with risperidone in the treatment of behavioral and psychological symptoms of dementia

Dementia is a neuropsychiatric disorder characterized by cognitive impairment and behavioral and psychological symptoms. The efficacy and tolerability of risperidone for treating dementia-associated psychological and behavioral disturbances were evaluated in a study of 135 patients aged 60-85 years with DSM-IV diagnoses of Alzheimer's disease. All were treated with risperidone at a starting dose of 0.5 mg once daily at bedtime. After the first 3 days of therapy the dosage was increased to 1 mg in 2 doses (morning and evening), then a further 0.5 mg was added (alternatively in the morning and in the evening) every three days until attenuation of the psychiatric symptoms. The response to treatment was evaluated for a period of 12 weeks by the Neuropsychiatric Inventory (NPI) and the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD). Both NPI and BEHAVE-AD were administered at the baseline visit, and after 4 and 12 weeks of therapy. Tolerability was assessed by the incidence of clinically evident side effects. The mean dose at endpoint was 1 mg/day of risperidone. The mean NPI score was 28.80+/-13.92 at start, 15.55+/-11.25 after 4 weeks and 8.30+/-7.00 at endpoint. The reduction in mean scores at 4 and 12 weeks was statistically significant in most of the Neuropsychiatric Inventory items, except for appetite disorders (p<0.0001). The mean BEHAVE-AD score was 20.44+/-3.92 at start, 13.50+/-11.39 after 4 weeks and 8.03+/-7.80 at endpoint. All the items showed a statistically significant improvement after 4 and 12 weeks (p<0.0001). The results were better at 12 than at 4 weeks. In our elderly patients with dementia low-dose risperidone was well tolerated and associated with reductions in BPSD, in particular agitation, aggression, irritability, delusions, sleep disorders, anxiety and phobias.     

Factor analysis of the Cohen-Mansfield Agitation Inventory in three large samples of nursing home patients with dementia and behavioral disturbance.

OBJECTIVE: Limited work has addressed the construct validity of the Cohen-Mansfield Agitation Inventory (CMAI) in nursing home patients. The authors tested the CMAI factor structure by use of data from three samples of nursing home patients categorized a priori as having at least mild behavioral and psychological symptoms of dementia. METHODS: CMAI data were from the baseline assessment of three randomized, placebo-controlled trials of risperidone for treating elderly nursing home patients. Exploratory factor analyses were conducted on two trials (N = 304; N = 344), and the results of these exploratory factor analyses were then tested with confirmatory factor analysis by use of data from a third trial (N = 617). RESULTS: Principal-components analysis suggested the presence of four factors: 1) Aggressive Behavior (hitting, kicking, scratching, biting, pushing, grabbing, throwing things, cursing or verbal aggression, spitting, tearing things/destroying property, hurting self or others, screaming); 2) Physically Non-Aggressive Behavior (pacing, trying to get to a different place, general restlessness, inappropriate dressing or disrobing, handling things inappropriately, performing repetitious mannerisms); 3) Verbally Agitated Behavior (complaining, constant requests for attention, repetitive questions, negativism); and 4) Hiding and Hoarding. Confirmatory factor analysis indicated that the four-factor solution was a reasonable fit to the data. CONCLUSION: Four factors emerged on the CMAI in nursing home patients with behavioral and psychological symptoms of dementia. The results obtained converge reasonably with previous publications concerning the factor structure of the CMAI, which, taken together, suggest a fairly robust factor structure for the instrument.     

Antipsychotic treatment of behavioral and psychological symptoms of dementia in geropsychiatric inpatients.

Behavioral/psychological symptoms of dementia (BPSD) affect caregiver burden and transition from home to hospital or long-term care. The authors examined change in BPSD for dementia patients (from hospital admission to discharge) who were prescribed haloperidol (n= 289), olanzapine (n=209), or risperidone (n=500). Olanzapine was associated with significantly greater overall improvement in BPSD (based on the Psychogeriatric Dependency Rating Scale total score) than risperidone or haloperidol. Olanzapine was significantly superior on measures of active-, verbal-, and passive-aggression and delusions/hallucinations to risperidone or haloperidol, and, on manipulative behavior and noisiness, to risperidone. Results support the effectiveness of olanzapine in improving several BPSD in hospitalized dementia patients.     

Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind,placebo-controlled trial with Melissa

BACKGROUND: Behavioral and psychological symptoms in dementia are frequent and are a major management problem, especially for patients with severe cognitive impairment. Preliminary reports have indicated positive effects of aromatherapy using select essential oils, but there are no adequately powered placebo-controlled trials. We conducted a placebo-controlled trial to determine the value of aromatherapy with essential oil of Melissa officinalis (lemon balm) for agitation in people with severe dementia. METHOD: Seventy-two people residing in National Health Service (U.K.) care facilities who had clinically significant agitation in the context of severe dementia were randomly assigned to aromatherapy with Melissa essential oil (N = 36) or placebo (sunflower oil) (N = 36). The active treatment or placebo oil was combined with a base lotion and applied to patients' faces and arms twice a day by caregiving staff. Changes in clinically significant agitation (Cohen-Mansfield Agitation Inventory [CMAI]) and quality of life indices (percentage of time spent socially withdrawn and percentage of time engaged in constructive activities, measured with Dementia Care Mapping) were compared between the 2 groups over a 4-week period of treatment. RESULTS: Seventy-one patients completed the trial. No significant side effects were observed. Sixty percent (21/35) of the active treatment group and 14% (5/36) of the placebo-treated group experienced a 30% reduction of CMAI score, with an overall improvement in agitation (mean reduction in CMAI score) of 35% in patients receiving Melissa balm essential oil and 11% in those treated with placebo (Mann-Whitney U test; Z = 4.1, p < .0001). Quality of life indices also improved significantly more in people receiving essential balm oil (Mann-Whitney U test; percentage of time spent socially withdrawn: Z = 2.6, p = .005; percentage of time engaged in constructive activities: Z = 3.5, p = .001). CONCLUSION: The finding that aromatherapy with essential balm oil is a safe and effective treatment for clinically significant agitation in people with severe dementia, with additional benefits for key quality of life parameters, indicates the need for further controlled trials.     

Behavioral and Psychological Signs and Symptoms of Dementia (BPSD) in antipsychotic-naïve Alzheimer's Disease patients

BACKGROUND/OBJECTIVE: There were few studies identifying the natural unfolding of behavioural and psychological symptoms of dementia (BPSD) in the course of Alzheimer's disease (AD) progression in antipsychotic-naive AD patients. This study aims to examine the specific nature of the association between BPSD in AD and the global severity of illness measured by Global Deterioration Scale(GDS) in antipsychotic-naive AD patients in Korea. METHODS: A total of 562 antipsychotics-naive AD patients were recruited from four different groups [a geriatric mental hospital (n = 145), a semi-hospitalized dementia institution (n = 120), a dementia clinic (n = 114) and community-dwelling dementia patients (n = 183)]. BPSD exhibited by AD patients were measured using the 25-item Korean version of the BEHAVE-AD. RESULTS: Ninety-two percent (n = 517) of AD patients had at least one BPSD, while 56% (n=315) had 4 or more BPSD. Specific kinds of behavioral disturbance peak at the stages of moderate AD (GDS stage 5) or moderately severe AD (GDS stage 6). AD patients left at home without any treatment had higher frequency of BPSD than did other groups seeking treatment, although all of them were antipsychotic-naive. CONCLUSION: BPSD potentially remediable to treatment were highly frequent in Korean AD patients. Health policies to meet the unmet needs of elderly Koreans are urgently needed, especially for AD patients at home without treatment.     

A comparative study of behavioral and psychological symptoms of dementia in patients with Alzheimer's disease and vascular dementia referred to psychogeriatric services in Korea and the U.K

BACKGROUND: There is a paucity of cross-cultural studies of behavioral and psychological symptoms of dementia (BPSD). METHOD: BPSD were examined in consecutive series of referrals to a psychogeriatric service in Korea and the U.K. using the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale and the Cornell Scale for Depression in Dementia (CSDD). Results were analyzed separately for Alzheimer's disease and vascular dementia. RESULTS: Koreans in both diagnostic groups had lower Mini-mental State Examination (MMSE) scores and higher BEHAVE-AD total and subscale scores for most subscales. In both countries, for both diagnostic groups, the total BEHAVE-AD score and several subscale scores were negatively correlated with the MMSE scores. Logistic regression analysis for Alzheimer's disease revealed that BEHAVE-AD total and most subscale scores independently predicted the country of origin in addition to the MMSE scores predicting the same. CONCLUSIONS: These differences in BPSD are most likely explained by the lower MMSE scores in the Korean sample. However, genuine differences in BPSD between the two countries can only be critically examined in a cross-cultural population-based epidemiological study for both diagnostic categories using validated instruments to measure BPSD and controlling for the influence of MMSE score.     

Effect of olanzapine on cognition during treatment of behavioral and psychiatric symptoms in patients with dementia: a post-hoc analysis

OBJECTIVE: This study was conducted to determine the effect of olanzapine treatment on cognition in elderly patients with behavioral and psychiatric symptoms (BPSD) associated with dementia. METHODS: This was a post-hoc analysis of three randomized double-blind, clinical trials of olanzapine (n = 682) vs placebo (n = 257) in dementia patients with BPSD in long-term or continuing-care settings. One study was 6 weeks long; the other two were 10 weeks duration, and their data were combined. Patients were subgrouped according to baseline Mini Mental State Examination (MMSE) scores: Group I = 23-26; Group II = 19-22; Group III = 14-18; Group IV = 7-13; Group V = 1-6. BPSD was assessed by the Neuropsychiatric Inventory (NPI). RESULTS: Within-treatment group cognitive decline in patients was significant in the combined studies, but not in the 6-week study. Between-treatment cognitive changes were non-significant in the 6-week study, but showed a statistical trend in the combined studies (olanzapine, -0.78 +/- 0.19 vs placebo, -0.32 +/- 0.25; p = 0.06). In the subgroup analysis, there was a significant between-treatment difference in cognitive changes in MMSE subgroup IV in the combined studies (olanzapine, -0.63 +/- 0.26 vs placebo, 0.27 +/- 0.41, p = 0.04). Improvement in BPSD was correlated with better cognitive outcome (r = -0.2; p < 0.01). CONCLUSIONS: Although the overall differences in cognitive changes in patients treated with olanzapine vs placebo were small and non-significant, negative effects on cognition in some patients cannot be excluded, especially in patients with more pronounced cognitive decline or whose behavioral and psychiatric symptoms are not responding to treatment.