• Dementia trials may have biased or even false-positive results if the study drug is not well
tolerated in the treatment group.• The CONSORT (Consolidated Standards of Reporting …

A strategy for assessing the clinical importance of statistically significant treatment benefits in
recent dementia drug trials is proposed. Traditional criteria for the assessment of valid …

Dementia is a substantial and increasing public health concern. Despite decades of
research, a cure or effective preventative treatment for dementia remains elusive. We offer …

The ability to define thresholds for the clinical significance (clinical importance) of outcome
measures in dementia drug research is critical to determining the changes on outcome …

Two suggested clinical trial designs for assessing progression of Alzheimer disease are the
randomized withdrawal design and the randomized start design. The most promising of …

Background: The results of clinical trials are routinely presented in terms of statistical
significance, which may or may not indicate clinical significance. Analysis of the minimal …

Alzheimer's disease (AD) clinical trials are designed and powered to detect the impact of a
therapeutic intervention, and there has been considerable discussion on what constitutes a …

Background: The social and economic burden of Alzheimer's disease (AD) and its
increasing prevalence has led to much work on new treatment strategies and clinical trials …

Background Intention-to-treat analysis is used in the analysis of randomized controlled trials
to preserve trial power in the presence of missing subject data as well as to control for both …

Trials missing primary efficacy end points raise the question of whether the choice of drug or
the limitations of disease biology were at fault. In some trials, drugs appear not to have …