Predictors of providing informed consent or assent for research participation in assisted living residents.

OBJECTIVES: This study's goal was to identify factors associated with providing either informed consent or assent for research in individuals at high risk for cognitive impairment. DESIGN: Cross-sectional baseline data were used to identify predictors of consent or assent status. SETTING: The study was conducted at 22 assisted living facilities in Maryland. PARTICIPANTS: A stratified random sample of 198 assisted living residents participated in the study. MEASUREMENTS: Residents' consent or assent status was documented as providing informed consent, written assent, or verbal assent/no objection. Potential predictors included residents' demographic characteristics, measures of physical and mental health status, and neuropsychological test performance. RESULTS: Most participants provided written assent (32.8%) or verbal assent/no objection (30.3%) rather than informed consent (36.9%). Although many resident characteristics correlated with consent or assent status based on bivariate analyses, few variables distinguished those who provided written assent from those in the verbal assent/no objection group. On the basis of multiple discriminant analysis, the best predictors of consent or assent status were Mini-Mental State Exam scores, impairments in instrumental activities of daily living, and dementia diagnosis, which together classified correctly 63.6% of residents. CONCLUSIONS: The relatively small proportion of participants who could provide informed consent highlights the importance of assessing decisional capacity for research in a high-risk population and identifying an appropriate surrogate decision maker to provide proxy consent if needed. Consensus on how to define assent is lacking, and specific measures of assent capabilities are needed to better characterize the assent capacity continuum.

Falls and age in patients with Alzheimer's disease.

The study's objective was to estimate the prevalence of falls in community-residing patients with Alzheimer's disease (AD) and to investigate the relationship between falls and age in AD. This was a study of 326 community-residing patients with AD according to National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association criteria. The patients and their caregivers were asked about falls, behavioral disturbances, and medication use within the last 2 weeks. The patients were also rated on standardized measures of cognitive impairment, stage of dementia, depression, daily activities, general health, and extrapyramidal symptoms. Falls occurred in 24 (7.4%) patients with AD during the last 2 weeks. Using multiple logistic regression analyses, falls were independently associated with old age (odds ratio = 1.2; p = .03; 95% confidence interval = 1.0 to 1.4) but not with other variables examined. The authors conclude that falls in community-residing patients with AD are significantly associated with old age. Population-based prospective studies are needed to investigate further the risk factors for falls in AD.

Cognitive response to pharmacological treatment for depression in Alzheimer disease: secondary outcomes from the depression in Alzheimer's disease study (DIADS).

OBJECTIVE: The authors assessed the cognitive effects of depression treatment with sertraline in patients with Alzheimer disease (AD) and major depression. METHODS: Forty-four patients with probable AD and major depression were enrolled in a double-blind, placebo-controlled clinical trial of sertraline. Cognitive testing was done at baseline and at 3-week intervals throughout the 12-week study. At the 12th week, subjects were categorized by treatment response (full, partial, or no response). Cognitive data from 41 participants who completed three or more testing sessions and 36 who completed all five study visits were included in the analyses. RESULTS: Neither improved mood nor use of sertraline was associated with cognitive change over time in AD patients. Post-hoc exploration of the data, however, suggested a sex difference in cognitive response to sertraline such that women treated with sertraline demonstrated improved cognition compared with women on placebo, whereas men treated with sertraline worsened significantly in cognition compared with men on placebo. CONCLUSIONS: In this study, among depressed AD patients after treatment with sertraline or placebo, there was no evidence that improved mood was associated with cognitive improvement. Future studies aimed at increasing power to detect mood as well as medication effects will be valuable in determining the relationship between cognition and treatment of depression in AD patients.

The Maryland Assisted Living Study: prevalence, recognition, and treatment of dementia and other psychiatric disorders in the assisted living population of central Maryland.

OBJECTIVES: To obtain a direct estimate of the prevalence of dementia and other psychiatric disorders in residents of assisted living (AL) in Central Maryland, and their rates of recognition and treatment. DESIGN: Comprehensive review of history and cognitive and neuropsychiatric evaluations using widely accepted instruments in a randomized cohort of AL residents, stratified by facility size. An expert multidisciplinary consensus panel determined diagnoses and appropriateness of treatment. SETTING: Twenty-two (10 large and 12 small) randomly selected AL facilities in the city of Baltimore and seven Maryland counties. PARTICIPANTS: One hundred ninety-eight volunteers who were residents of AL, 75% were aged 80 and older, and 78% were female. Potential participants were randomly chosen by room number. There was a 67% participation rate. MEASUREMENTS: Overall rate of dementia, noncognitive active psychiatric disorders, and recognition and adequate treatment of dementia and psychiatric disorders, as determined by consensus panel. RESULTS: Two-thirds (67.7%) of participants had dementia diagnosable according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (81% small facilities and 63% large). Family or caregivers recognized 78% to 80% of dementias. Seventy-three percent of dementias were adequately evaluated, and 52% were adequately treated. Of the 26.3% of participants who had an active noncognitive psychiatric disorder, 58% to 61% were recognized and 52% adequately treated. CONCLUSION: Dementia and psychiatric disorders are common in AL and have suboptimal rates of recognition and treatment. This may contribute to morbidity and interfere with the ability of residents to age in place.

Treating depression in Alzheimer disease: efficacy and safety of sertraline therapy, and the benefits of depression reduction: the DIADS.

CONTEXT: Major depression affects about 25% of the patients who have Alzheimer disease and has serious adverse consequences for patients and caregivers. Results of prior antidepressant treatment studies have produced contradictory findings and have not fully assessed the benefits of depression reduction. OBJECTIVES: To assess the efficacy and safety of sertraline hydrochloride for the treatment of major depression in Alzheimer disease, and to evaluate the effect of depression reduction on activities of daily living, cognition, and nonmood behavioral disturbance. DESIGN: Randomized, placebo-controlled, parallel, 12-week, flexible-dose clinical trial with a 1-week, single-blind placebo phase. The study was conducted between January 1, 1998, and July 19, 2001. SETTING: University outpatient clinic. PARTICIPANTS: Forty-four outpatients who have probable Alzheimer disease and major depressive episodes. INTERVENTION: Sertraline hydrochloride, mean dosage of 95 mg/d, or identical placebo, randomly assigned. MAIN OUTCOME MEASURES: Response rate, Cornell Scale for Depression in Dementia, Hamilton Depression Rating Scale, Mini-Mental State Examination, Psychogeriatric Depression Rating Scale-activities of daily living subscale, and Neuropsychiatric Inventory to quantify patient behavior disturbance and caregiver distress. RESULTS: In the sertraline-treated group 9 patients (38%) were full responders and 11 (46%) were partial responders compared with 3 (20%) and 4 (15%), respectively, in the placebo-treated group (P =.007). The sertraline-treated group had greater improvements in the scores for the Cornell Scale for Depression in Dementia (P =.002) and Hamilton Depression Rating Scale (P =.01), and a statistical trend toward less decline in activities of daily living on the Psychogeriatric Depression Rating Scale-activities of daily living subscale (P =.07). There was no difference between the treatment groups in Mini-Mental State Examination (P =.22) or Neuropsychiatric Inventory (P =.32) ratings over time. When full responders, partial responders, and nonresponders were compared, full responders only, or full and partial responders had significantly better ratings on activities of daily living (P =.04), behavioral disturbance (P =.01), and caregiver distress (P =.006), but not on the Mini-Mental State Examination (P =.76). Safety monitoring indicated few differences in adverse effects between the 2 treatment groups. CONCLUSIONS: Sertraline is superior to placebo for the treatment of major depression in Alzheimer disease. Depression reduction is accompanied by lessened behavior disturbance and improved activities of daily living, but not improved cognition.

The relationship between delusions and depression in Alzheimer's disease.

OBJECTIVES: The aim of this investigation was to study the relationship between delusions and depression in Alzheimer's disease (AD). DESIGN: This was a cross-sectional, case control study. SETTING: Neuropsychiatry Service, the Johns Hopkins School of Medicine, USA. PARTICIPANTS: 303 community-residing patients with probable AD according to NINCDS/ADRDA criteria were included in the study. Seventy-five patients with delusions only were compared to a control group of 228 patients who had neither delusions nor hallucinations. Patients with only hallucinations or both delusions and hallucinations were excluded. MEASURES: Patients were assessed clinically for the presence of delusions using the DSM-IV glossary definitions. They were also rated on standardized measures of depression, cognitive impairment, staging of dementia, general medical health, and functional impairment. RESULTS: There was an association between delusions and depression among patients with AD. Before adjustment for other variables, the presence of depression conferred a 1.8-fold (95% confidence intervals (CI) = 1.0-3.1; p = 0.04) higher risk of delusions. After adjustment for multiple other variables, this risk increased further to 6.8-fold (95% CI = 2.1-21.6; p = 0.001). CONCLUSIONS; Delusions in AD are strongly associated with depression after statistical adjustment for all confounding variables, which might distort this association. This finding has implications for our understanding of the etio-pathogenesis and management of delusions and depression in AD.

Isolated hallucinosis in Alzheimer's disease is associated with African-American race.

OBJECTIVES: The aim of this investigation was to study the relationship between isolated hallucinosis and race in Alzheimer's disease. METHODS: This was a cross-sectional, case control study carried out at the Neuropsychiatry Service, outpatient clinic at the Johns Hopkins School of Medicine, USA. The participants were 237 community-residing patients with probable Alzheimer's disease according to NINCDS/ADRDA criteria were included in the study. 9 patients with isolated hallucinosis were compared to a control group of 228 patients who had neither delusions nor hallucinations. Patients with only delusions or both delusions and hallucinations were excluded based on prior research. Patients were assessed clinically for the presence of hallucinations using the DSM-IV glossary definitions. They were also rated on standardized measures of cognitive impairment, depression, functional impairment, and general health. RESULTS: There was a significant association between hallucinations and race in patients with Alzheimer's disease. Before adjustment for other variables, the African-American race conferred a 5.5-fold (95% CI = 1.4-21.6; p = 0.02) increased risk for isolated hallucinosis. After adjustment for multiple other variables, this risk increased further to 27.2-fold (95% CI = 1.6-457.3; p = 0.02). CONCLUSIONS: African-American patients with Alzheimer's disease are more likely to have isolated hallucinations than Caucasian patients even after statistical adjustment for multiple confounding variables, which might distort this association. This finding has implications for our understanding of the etio-pathogenesis of hallucinations in Alzheimer's disease and for meeting health service needs of African-American patients.

A Scale to Measure Impairment in Severe Dementia and Similar Conditions.

The authors describe an 11-item, 22-point scale that measures cognitive capacity in severely cognitively impaired individuals. The Severe Impairment Rating Scale (SIRS) has acceptable interrater reliability (r = 0.992; P < 0.001), test-retest reliability (r = 0.97; P < 0.0001), and internal consistency (Chronbach's alpha = 0.76). Validity is supported by correlations with the Glasgow Coma Scale (r = 0.866; P < 0.001) and Mini-Mental State Examination (r = 0.770; P < 0.001).