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In this randomized trial of atypical antipsychotic medications in patients with Alzheimer's disease and psychosis, aggression, or agitation, effectiveness (as measured by the time to drug discontinuation) was similar for olanzapine, risperidone, quetiapine, and placebo. Patients were more likely to stop taking placebo because of lack of efficacy and were likely to stop taking antipsychotic medications because of intolerability. In this trial of atypical antipsychotic medications in patients with Alzheimer's disease, effectiveness was similar for olanzapine, risperidone, quetiapine, and placebo. Patients were more likely to stop taking placebo because of lack of efficacy and to stop taking antipsychotic medications because of intolerability. Delusions, hallucinations, aggression, and agitation affect more than half of patients with Alzheimer's disease and related dementias. 1 – 4 Antipsychotic drugs are used to treat these behaviors and symptoms and are among the most frequently used psychotropic drugs in Alzheimer's disease. 5 , 6 Second-generation (atypical) antipsychotic drugs have been considered to be at least as effective as conventional antipsychotic agents such as haloperidol, with a lower risk of most adverse effects, 7 and are used as first-line pharmacologic treatments for patients with dementia. 5 , 8 However, there is a dearth of placebo-controlled and active-drug–controlled, randomized trials and longer-term data from controlled trials regarding the . . .

The authors describe the development of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) protocol for Alzheimer disease (AD), a trial developed in collaboration with the National Institute of Mental Health (NIMH), assessing the effectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. They provide an overview of the methodology utilized in the trial as well as the clinical-outcomes and effectiveness measures that were implemented.

Atypical antipsychotic medications are widely used to treat delusions, aggression, and agitation in people with Alzheimer disease (AD) and other dementia. Several clinical trials have not shown efficacy, and there have been concerns about adverse events. The objective of this study was to assess the evidence for efficacy and adverse events of atypicals for people with dementia MEDLINE, the Cochrane Register of Controlled Trials, meetings, presentations, and information obtained from sponsors were used in this study. Published and unpublished randomized, placebo-controlled, double-blind, parallel-group trials in patients with AD or dementia of atypical antipsychotics marketed in the United States were studied. Clinical and trials characteristics, outcomes, and adverse events were extracted. Data were checked by a second reviewer. Fifteen trials including 16 contrasts of atypical antipsychotics with placebo met selection criteria: aripiprazole (k = 3), olanzapine (k = 5), quetiapine (k = 3), and risperidone (k = 5). A total of 3,353 patients were randomized to drug and 1,757 to placebo. Standard meta-analysis methods were used to summarize outcomes. Quality of the reporting of trials varied. Efficacy on rating scales was observed by meta-analysis for aripiprazole and risperidone, but not for olanzapine. Response rates were frequently not reported. There were smaller effects for less severe dementia, outpatients, and patients selected for psychosis. Approximately one-third dropped out without overall differences between drug and placebo. Adverse events were mainly somnolence and urinary tract infection or incontinence across drugs, and extrapyramidal symptoms or abnormal gait with risperidone or olanzapine. Cognitive test scores worsened with drugs. There was no evidence for increased injury, falls, or syncope. There was a significant risk for cerebrovascular events, especially with risperidone; increased risk for death overall was reported elsewhere. Small statistical effect sizes on symptom rating scales support the evidence for the efficacy of aripiprazole and risperidone. Incomplete reporting restricts estimates of response rates and clinical significance. Dropouts and adverse events further limit effectiveness. Atypicals should be considered within the context of medical need and the efficacy and safety of alternatives. Individual patient meta-analyses are needed to better assess clinical significance and effectiveness.

Abstract The Coronavirus disease 2019 (COVID-19) pandemic has introduced numerous challenges to the global scientific community and has been particularly disruptive to the conduct of ongoing clinical trials. Gerontological studies that focus on older adults with cognitive impairments have endured additional challenges ranging from increased vulnerability of this group to COVID-19, thereby prohibiting study participation, to difficulties in participant engagement as a product of a worsening Digital Divide. The purpose of this talk is to describe the pandemic-related factors that have influenced recruitment and enrollment of older adults with mild cognitive impairment and mild dementia in an ongoing feasibility study of a physical activity smartphone app. We discuss the changes we made to recruitment procedures and the impact those changes have had on the success of enrolling individuals in the study. We conclude with a discussion of feasible strategies and procedural alterations moving forward that may facilitate achievement of enrollment goals.