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

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Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study

PURPOSE OF THE STUDY: During aging, musical activities can help maintain physical and mental health and cognitive abilities, but their rehabilitative use has not been systematically explored in persons with dementia (PWDs). Our aim was to determine the efficacy of a novel music intervention based on coaching the caregivers of PWDs to use either singing […]

Antioxidant effect of astaxanthin on phospholipid peroxidation in human erythrocytes

Phospholipid hydroperoxides (PLOOH) accumulate abnormally in the erythrocytes of dementia patients, and dietary xanthophylls (polar carotenoids such as astaxanthin) are hypothesised to prevent the accumulation. In the present study, we conducted a randomised, double-blind, placebo-controlled human trial to assess the efficacy of 12-week astaxanthin supplementation (6 or 12 mg/d) on both astaxanthin and PLOOH levels in […]

Methodological issues in a cluster-randomized trial to prevent dementia by intensive vascular care

Objectives: Description of methodological issues in a trial designed to evaluate if a multi-component intervention aimed at vascular risk factors can prevent dementia.; Design, Setting and Participants: Multi-center, open, cluster-randomized controlled clinical trial (preDIVA) including 3535 non-demented subjects aged 70-78, executed in primary practice and coordinated from one academic hospital. General practices are randomized to […]

Study protocol of the multi-site randomised controlled REDALI-DEM trial–the effects of structured relearning methods on daily living task performance of persons with dementia

Background: Evidence from pilot trials suggests that structured learning techniques may have positive effects on the performance of cognitive tasks, movement sequences or skills in patients with Alzheimer’s disease. The purpose of this trial is to evaluate whether the usual method of learning by trial and error or the method of errorless learning demonstrate better […]

11C-PiB PET assessment of change in fibrillar amyloid-beta load in patients with Alzheimer’s disease treated with bapineuzumab: a phase 2, double-blind, placebo-controlled, ascending-dose study

Background: Carbon-11-labelled Pittsburgh compound B ((11)C-PiB) PET is a marker of cortical fibrillar amyloid-beta load in vivo. We used (11)C-PiB PET to investigate whether bapineuzumab, a humanised anti-amyloid-beta monoclonal antibody, would reduce cortical fibrillar amyloid-beta load in patients with Alzheimer’s disease.; Methods: Patients with mild-to-moderate Alzheimer’s disease were randomly assigned to receive intravenous bapineuzumab or […]

Evaluation of the convenience of changing the rivastigmine administration route in patients with Alzheimer disease

Introduction: Rivastigmine transdermal patches for the treatment of Alzheimer’s disease (AD) have potential benefits compared to capsules because of their sustained absorption through the skin, good local tolerability and reduction of gastrointestinal problems.; Purpose: To assess gastrointestinal and skin tolerability and the need for optimal dose titration of rivastigmine transdermal patches in Alzheimer’s disease patients […]

Diet intervention and cerebrospinal fluid biomarkers in amnestic mild cognitive impairment

Objective: To compare the effects of a 4-week high-saturated fat/high-glycemic index (HIGH) diet with a low-saturated fat/low-glycemic index (LOW) diet on insulin and lipid metabolism, cerebrospinal fluid (CSF) markers of Alzheimer disease, and cognition for healthy adults and adults with amnestic mild cognitive impairment (aMCI).; Design: Randomized controlled trial.; Setting: Veterans Affairs Medical Center clinical […]

A randomized pilot clinical trial of the safety of pioglitazone in treatment of patients with Alzheimer disease

Objectives: To evaluate the safety of the peroxisome proliferator-activated receptor gamma agonist pioglitazone in nondiabetic patients with Alzheimer disease (AD) and to explore treatment effect sizes on clinical outcomes.; Design: Double-blind, placebo-controlled randomized controlled trial of 18-month duration.; Setting: Two academic medical center outpatient clinics.; Patients: Nondiabetic patients meeting research criteria for probable AD were […]

Double-blind, controlled phase II study of a 5-HT6 receptor antagonist, SB-742457, in Alzheimer’s disease

Background: This randomized, double-blind, placebo-controlled study investigated the efficacy and tolerability of the 5-HT6 receptor antagonist, SB-742457, in subjects with mild-to-moderate probable Alzheimer’s disease (AD).; Methods: Participating subjects had a Mini-Mental State Examination (MMSE) score of 12 to 26 after a 4-week, single-blind, placebo run-in phase, and were randomized (2:1:1:2) to receive placebo, SB-742457 5 […]

Effect of an antioxidant drink on homocysteine levels in Alzheimer’s patients

Background: A large body of evidence supports a role of oxidative stress in Alzheimer disease (AD) and in cerebrovascular disease. Blood levels of homocysteine may be increased in AD and hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms. Even in the absence of vitamin deficiency, plasma total homocysteine (tHcy) concentration may […]

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