6/28/23, 12:28 AM Clarity AD Pathway Feedback Search Clinical Topics Home Studies Clarity AD Clarity AD Disease Alzheimer's disease Trial question What is the role of lecanemab in patients with early Alzheimer's disease? Study design Multi-center Double blinded RCT Population Characteristics of study participants 52.0% female N = 1734 48.0% male 1734 patients (907 female, 827 male) Inclusion criteria: participants 50-90 years of age with early Alzheimer's disease with evidence of amyloid on positron-emission tomography or by CSF testing Key exclusion criteria: any neurological condition that may be contributing to cognitive impairment above and beyond that caused by participant's Alzheimer's disease; history of TIAs, stroke, seizures within 12 months of screening; any psychiatric diagnosis or symptoms Interventions N=859 lecanemab (an intravenous dose of 10 mg/kg every 2 weeks) N=875 placebo (matching placebo every 2 weeks) Primary outcome Reduction in clinical dementia rating-sum of boxes at 18 months 1.7 1.66 https://web.pathway.md/studies/recTq7cu4CChfHOXR 1/2 6/28/23, 12:28 AM Clarity AD Pathway 1.2 1.21 0.8 0.4 Significant decrease 0.0 Lecanemab Placebo Significant decrease in reduction in the clinical dementia rating-sum of boxes at 18 months (1.21 vs. 1.66; ARD -0.45, 95% CI -0.67 to -0.23) Secondary outcomes Significant decrease in reduction in 14-item Cognitive Subscale of the Alzheimer's Disease Assessment Scale (4.14 vs. 5.58; ARD -1.44, 95% CI -2.27 to -0.61) Significant decrease in reduction in Alzheimer's disease composite score (0.164 vs. 0.214; ARD -0.05, 95% CI -0.07 to -0.03) Significant increase in improvement in Alzheimer's disease cooperative study-activities of daily living scale for mild cognitive impairment score (-3.5 vs. -5.5; AD 2, 95% CI 1.2 to 2.8) Safety outcomes No significant difference in adverse events and serious adverse events including death. Conclusion In participants 50-90 years of age with early Alzheimer's disease with evidence of amyloid on positron-emission tomography or by CSF testing, lecanemab was superior to placebo with respect to reduction in the clinical dementia rating-sum of boxes at 18 months. Reference Christopher H van Dyck, Chad J Swanson, Paul Aisen et al. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. Open reference URL https://web.pathway.md/studies/recTq7cu4CChfHOXR 2/2