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

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Vitamins B(12), B(6), and folic acid for cognition in older men
Objective: To investigate whether supplementing older men with vitamins B(12), B(6), and folic acid improves cognitive function.; Methods: The investigators recruited 299 community-representative hypertensive men 75 years and older to a randomized, double-blind controlled clinical trial of folic acid, vitamin B(6), and B(12) supplementation vs placebo over 2 years. The primary outcome of interest was […]

Rosiglitazone monotherapy in mild-to-moderate Alzheimer’s disease: results from a randomized, double-blind, placebo-controlled phase III study
Background/aims: A phase II study of the peroxisome proliferator-activated receptor-γ agonist rosiglitazone extended release (RSG XR) in mild-to-moderate Alzheimer’s disease (AD) detected a treatment benefit to cognition in apolipoprotein E(APOE)-ε4-negative subjects. The current phase III study with prospective stratification by APOE genotype was conducted to confirm the efficacy and safety of RSG XR in mild-to-moderate […]

Safety and efficacy of galantamine (Reminyl) in severe Alzheimer’s disease (the SERAD study): a randomised, placebo-controlled, double-blind trial
Background: The efficacy of galantamine has been shown in patients with mild, moderate, and advanced moderate Alzheimer’s disease (AD). Here we report its efficacy in patients with severe AD.; Methods: Between December, 2003, and March, 2007, patients aged 84 (SD 6) years with severe AD (mini-mental state examination [MMSE] score 5-12 points), in a nursing […]

Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study
Following a 48-week, double-blind, randomized, placebo-controlled trial of donepezil in 821 patients with amnestic mild cognitive impairment (aMCI), safety and tolerability of donepezil (10 mg) were further evaluated in a 28-week extension study. Of 499 participants who completed the double-blind phase, 145 enrolled in the open-label study. Adverse events (AEs) were recorded throughout. Overall, 57.4% […]

A randomized, placebo-controlled trial of latrepirdine in Huntington disease
Objectives: To evaluate the safety and tolerability of latrepirdine in Huntington disease (HD) and explore its effects on cognition, behavior, and motor symptoms.; Design: Double-blind, randomized, placebo-controlled trial.; Setting: Multicenter outpatient trial.; Participants: Ninety-one participants with mild to moderate HD enrolled at 17 US and UK centers from July 18, 2007, through July 16, 2008.; […]

Efficacy of akatinol memantine in moderate cognitive impairments
A six-month open clinical trial of the efficacy of Akatinol was conducted in 40 patients with moderate cognitive impairments (MCI) using piracetam (20 patients) as reference agent; mean age was 67.7 +/- 7.2 years. Patient status was evaluated using a number of scales, questionnaires, and neuropsychological tests prior to treatment and at three and six […]

Can leisure activities slow dementia progression in nursing home residents? A cluster-randomized controlled trial
BACKGROUND: To examine the effects of complex cognitive (mahjong) and physical (Tai Chi) activities on dementia severity in nursing home residents with dementia. METHODS: Cluster-randomized open-label controlled design. 110 residents were randomized by nursing home into three conditions: mahjong, Tai Chi, and simple handicrafts (control). Activities were conducted three times a week for 12 weeks. […]

Donepezil treatment of older adults with cognitive impairment and depression (DOTCODE study): clinical rationale and design
Treatment strategies for patients with depression and cognitive impairment (DEP-CI), who are at high risk to develop a clinical diagnosis of dementia, are not established. This issue is addressed in the donepezil treatment of cognitive impairment and depression (DOTCODE) pilot clinical trial. The DOTCODE study is the first long-term treatment trial that assesses differences in […]

A telephone intervention for dementia caregivers: background, design, and baseline characteristics
Family caregivers of individuals with dementia are at heightened risk for emotional and mental health problems. Many caregivers do not seek assistance or become isolated in their caregiving role. Multi-component interventions have demonstrated efficacy for reducing emotional distress and burden, although these approaches are potentially costly and are not widely accessible. In response to these […]

Vitamin E and memantine in Alzheimer’s disease: clinical trial methods and baseline data
Background: Alzheimer’s disease (AD) has been associated with both oxidative stress and excessive glutamate activity. A clinical trial was designed to compare the effectiveness of (i) alpha-tocopherol, a vitamin E antioxidant; (ii) memantine (Namenda), an N-methyl-D-aspartate antagonist; (iii) their combination; and (iv) placebo in delaying clinical progression in AD.; Methods: The Veterans Affairs Cooperative Studies […]

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