Treatment trials in aging and mild cognitive impairment

Abstract

There are currently no FDA-approved therapies for mild cognitive impairment (MCI) as no treatment trial to date has convincingly demonstrated a significant effect on cognition or symptom progression. Whether the problem lies with the evaluated compounds, drugs previously shown to have therapeutic benefit in Alzheimer disease (AD), or the clinical trial designs themselves, remains unclear. However, future trials will likely need to use strategies to enrich for more homogeneous samples with appropriate biological characteristics at entry, define optimal treatment durations, and develop highly sensitive assessments and reliable outcomes with the power to detect change and treatment benefit in mildly impaired subjects.