New 48-month findings from the Clarity-AD (NCT03887455) open-label extension (OLE) study, presented at the 2025 Alzheimer’s Association International Conference (AAIC), indicate that individuals with early Alzheimer’s disease (AD) who received continuous treatment with Leqembi experienced slower clinical progression. Notably, those with low tau levels showed sustained improvements in cognition and daily functioning when compared with matched controls from the Alzheimer’s Disease Neuroimaging Initiative (ADNI).
Clarity-AD is a phase 3 randomised clinical trial assessing Leqembi in individuals with early symptomatic AD, followed by an ongoing OLE phase. Participants received Leqembi 10 mg/kg every two weeks, with 48-month outcomes measured using the Clinical Dementia Rating–Sum of Boxes (CDR-SB), Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog14), and Alzheimer’s Disease Cooperative Study–Activities of Daily Living for Mild Cognitive Impairment (ADCS-MCI-ADL). Researchers compared results from the treatment group with placebo data from ADNI-matched external controls, focusing on subgroups with no or low baseline tau.
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The Leqembi-treated cohort showed greater reductions in cognitive decline, with CDR-SB score differences of:
- 0.52 points at 18 months
- 1.01 points at 36 months
- 1.75 points at 48 months
Participants with no or low baseline tau demonstrated the highest rates of clinical stability or improvement:
- CDR-SB: 69% showed no decline, 56% showed improvement
- ADAS-Cog14: 15% showed no decline, 51% showed improvement
- ADCS-MCI-ADL: 64% showed no decline, 58% showed improvement
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