Abstract
There is an urgent need for Alzheimer's disease (AD) treatments because of the growing number of individuals with preclinical, prodromal, and dementia forms of AD. Unfortunately, there are few effective treatments for AD, and many drug development trials for AD ultimately have failed. Current AD clinical trials include disease-modifying therapies, symptomatic cognitive enhancers, and symptomatic agents addressing neuropsychiatric and behavioral changes. Disease modifying therapies include anti-amyloid agents and anti-tau agents, both of which contain small molecules, monoclonal antibodies, or biological therapies. Amyloid is the most common specific target in phase 3 and phase 2 disease modification trials. Recent drug development trials for AD include preclinical and prodromal populations. Although biomarkers are increasingly used in drug development for AD, they are not used uniformly for confirmation of AD diagnosis. Enrollment of earlier populations, new biomarkers (e.g., neurofilament light), novel outcomes (e.g., AD Composite Score [ADCOMS]), and innovative trial designs (e.g., futility analysis, Bayesian adaptive designs) are needed to develop effective drugs against AD.
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