The search for clarity regarding "clinically meaningful outcomes" in Alzheimer disease clinical trials: CLARITY-AD and Beyond.

ABSTRACT: CLARITY-AD is an 18-month, double-blinded, placebo-controlled, phase 3 trial which examined the safety and efficacy of the anti-amyloid agent, lecanemab, in mild cognitive impairment and mild dementia due to Alzheimer disease (AD). Lecanemab effectively reduced mean brain amyloid burden and was associated with statistically significant favorable effects, reflected by moderately less decline in the primary and secondary clinical outcomes, at 18 months compared to placebo. However, there is controversy within the AD community regarding the clinical significance of these results and whether they translate into clinically meaningful and tangible benefits on cognition or daily functions.We here review the primary and secondary clinical outcomes of CLARITY-AD and present our interpretation of th

SUBMITTER: Tarawneh R 

PROVIDER: S-EPMC10870501 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature