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This database contains 664 studies, archived under the term: "Randomised Controlled Trial"

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Successful ingredients in the SMILE study: Resident, staff, and management factors influence the effects of humor therapy in residential aged care

Objective: To test the hypothesis that individual and institutional-level factors influence the effects of a humor therapy intervention on aged care residents. Methods: Data were from the humor therapy group of the Sydney Multisite Intervention of LaughterBosses and ElderClowns, or SMILE, study, a single-blind cluster randomized controlled trial of humor therapy conducted over 12 weeks; […]

Yogic meditation reverses NF-κB and IRF-related transcriptome dynamics in leukocytes of family dementia caregivers in a randomized controlled trial

Background: Although yoga and meditation have been used for stress reduction with reported improvement in inflammation, little is known about the biological mechanisms mediating such effects. The present study examined if a yogic meditation might alter the activity of inflammatory and antiviral transcription control pathways that shape immune cell gene expression. Methods: Forty-five family dementia […]

Results of the citalopram to enhance cognition in Huntington disease trial

Background: The objective of this study was to evaluate citalopram for executive functioning in Huntington’s disease (HD).; Methods: The study was randomized, double-blind, and placebo-controlled. Thirty-three adults with HD, cognitive complaints, and no depression (Hamilton Depression [HAM-D] rating scale ≤ 12) were administered citalopram 20 mg or placebo (7 visits, 20 weeks), with practice and […]

Escitalopram versus risperidone for the treatment of behavioral and psychotic symptoms associated with Alzheimer’s disease: a randomized double-blind pilot study

Background: Antipsychotics are frequently used to treat psychosis, aggression and agitation in patients with Alzheimer’s disease (AD), but safety warnings abound. Escitalopram was investigated since citalopram has demonstrated some effectiveness in AD. We compared escitalopram and risperidone for psychotic symptoms and agitation associated with AD.; Methods: Inpatients with AD, who had been hospitalized because of […]

Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial

Background: Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo.; Methods: We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants […]

The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial

Background: Data from 12-week placebo-controlled trials have led to mounting concerns about increased mortality in patients with Alzheimer’s disease (AD) who are prescribed antipsychotics; however, there are no mortality data from long-term placebo-controlled trials. We aimed to assess whether continued treatment with antipsychotics in people with AD is associated with an increased risk of mortality.; […]

Optimal dosing of galantamine in patients with mild or moderate Alzheimer’s disease: post Hoc analysis of a randomized, double-blind, placebo-controlled trial

Background: Galantamine (hydrobromide), a reversible acetylcholinesterase inhibitor and allosteric nicotinic receptor modulator, slows cognitive and functional decline in mild to moderate dementia of the Alzheimer’s type. Although several drugs are indicated for mild to moderate Alzheimer’s disease (AD), no published study has separately analysed mild and moderate AD subgroups to assess the effect of dosage.; […]

Exergaming and older adult cognition: a cluster randomized clinical trial

Background: Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or “exergames” may elicit greater participation.; Purpose: To test the following hypotheses: (1) stationary cycling with virtual reality tours (“cybercycle”) will enhance executive function and […]

Renin-angiotensin system blockade and cognitive function in patients at high risk of cardiovascular disease: analysis of data from the ONTARGET and TRANSCEND studies

Background: cardiovascular risk factors are associated with dementia and cognitive decline. We investigated the effects of renin-angiotensin system blockade on cognitive function in patients aged 55 years and older with established atherosclerotic cardiovascular disease or diabetes with end-organ damage in two clinical trials.; Methods: in the main study, ONTARGET, a double-blind, double-dummy, randomised controlled trial, […]

Cognitive stimulation for Portuguese older adults with cognitive impairment: A randomized controlled trial of efficacy, comparative duration, feasibility, and experiential relevance

Although some studies point to cognitive stimulation as a beneficial therapy for older adults with cognitive impairments, this area of research and practice is still lacking dissemination and is underrepresented in many countries. Moreover, the comparative effects of different intervention durations remain to be established and, besides cognitive effects, pragmatic parameters, such as cost-effectiveness and […]

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