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

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Effect of oxcarbazepine in the treatment of agitation and aggression in severe dementia

Background/aims: To evaluate the efficacy of oxcarbazepine (OXC) in the treatment of agitation and aggression in patients with Alzheimer’s disease, vascular dementia or both.; Methods: This is an 8-week, multicenter, randomized, double-blind, placebo-controlled trial carried out independently of the pharmaceutical industry. Changes in the agitation and aggression subscore of the Neuropsychiatric Inventory (NPI) were the […]

Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial

Context: The herbal product Ginkgo biloba is taken frequently with the intention of improving cognitive health in aging. However, evidence from adequately powered clinical trials is lacking regarding its effect on long-term cognitive functioning.; Objective: To determine whether G. biloba slows the rates of global or domain-specific cognitive decline in older adults.; Design, Setting, and […]

Long-term effects of rivastigmine capsules in patients with traumatic brain injury

Objective: To investigate the safety, tolerability and efficacy of rivastigmine capsules (3-12 mg/day) in a 26-week, multi-centre, open-label extension of a double-blind study.; Methods: Patients with traumatic brain injury (TBI) and persistent cognitive impairment who had received rivastigmine (3-6 mg/day) or placebo for 12 weeks could enter the extension study and receive rivastigmine (< or […]

Domain-specific cognitive effects of tramiprosate in patients with mild to moderate Alzheimer’s disease: ADAS-cog subscale results from the Alphase Study

Objectives: Tramiprosate (homotaurine, ALZHEMEDTM) was recently investigated for its efficacy, safety and disease-modification effects in a Phase III clinical study in mild to moderate Alzheimer’s disease (AD) patients (the Alphase study). The primary cognitive endpoint measure of that study was the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog). To characterize potential cognitive benefits of tramiprosate, the […]

A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease

Background: Bapineuzumab, a humanized anti-amyloid-beta (Abeta) monoclonal antibody for the potential treatment of Alzheimer disease (AD), was evaluated in a multiple ascending dose, safety, and efficacy study in mild to moderate AD.; Methods: The study enrolled 234 patients, randomly assigned to IV bapineuzumab or placebo in 4 dose cohorts (0.15, 0.5, 1.0, or 2.0 mg/kg). […]

Effects of cranial electrical stimulation on sleep disturbances, depressive symptoms, and caregiving appraisal in spousal caregivers of persons with Alzheimer’s disease

Purpose: The purpose of this work was to investigate the effects of cranial electrical stimulation (CES) on sleep disturbances, depressive symptoms, and caregiving appraisal.; Methods: Thirty-eight participants were randomly assigned to receive active CES or sham CES for 4 weeks.; Results: Both intervention groups demonstrated improvement in study measures from baseline scores. A trend toward […]

Prevention of dementia by intensive vascular care (PreDIVA): a cluster-randomized trial in progress

Background and Purpose: Cardiovascular risk factors are associated with an increased risk of dementia. Treatment of hypertension and hypercholesterolemia is associated with a decrease in incident dementia. Whether interventions aimed at cardiovascular risk factors in late life also reduce dementia risk is unknown. Here, we report the outline of a pragmatic study that will attempt […]

Nursing home resident outcomes from the Res-Care intervention

Objectives: To test the effectiveness of a restorative care (Res-Care) intervention on function, muscle strength, contractures, and quality of life of nursing home residents, with secondary aims focused on strengthening self-efficacy and outcome expectations.; Design: A randomized controlled repeated-measure design was used, and generalized estimating equations were used to evaluate status at baseline and 4 […]

Efficacy of a vitamin/nutriceutical formulation for moderate-stage to later-stage Alzheimer’s disease: a placebo-controlled pilot study

Recent studies demonstrated efficacy of a vitamin/ nutriceutical formulation (folate, vitamin B12, alpha-tocopherol, S-adenosyl methionine, N-acetyl cysteine, and acetyl-L-carnitine) for mild to moderate Alzheimer’s disease. Herein, we tested the efficacy of this formulation in a small cohort of 12 institutionalized patients diagnosed with moderate-stage to later-stage Alzheimer’s disease. Participants were randomly separated into treatment of […]

A randomized, double-blind, placebo-controlled tolerability study of intramuscular aripiprazole in acutely agitated patients with Alzheimer’s, vascular, or mixed dementia

Objectives: To evaluate the tolerability of intramuscular (IM) aripiprazole in patients with agitation associated with dementia.; Design: A 24-hour, double-blind, placebo-controlled, randomized study.; Setting: Sixteen healthcare facilities in the United States.; Participants: A total of 129 patients with acute agitation associated with Alzheimer’s, vascular or mixed dementia in healthcare facilities.; Intervention: Patients were randomized to […]

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