Clarity AD
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
48.0% male
N = 1734
1734 patients (907 female, 827 male)
Inclusion criteria: patients 50-90 years of age with early Alzheimer's disease with evidence of amyloid on PET or CSF testing
Key exclusion criteria: any neurological condition that may be contributing to cognitive impairment above and beyond that caused by patient'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
1.21
1.66
1.7
1.2
0.8
0.4
0.0
Lecanemab
Placebo
Significant
decrease ▼
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 points vs. 5.58 points; ARD -1.44, 95% CI -2.27 to -0.61)
Significant decrease in reduction in Alzheimer's disease composite score (0.164 points vs. 0.214 points; 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 MCI score (-3.5 points vs. -5.5 points; AD 2 points, 95% CI 1.2 to 2.8)
Safety outcomes
No significant difference in adverse events and serious adverse events including death.
Conclusion
In patients 50-90 years of age with early Alzheimer's disease with evidence of amyloid on PET or 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.
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