Drug Development

Area of Science:

• Neurology
• Pharmacology
• Geriatrics

Background:

• Alzheimer's disease (AD) is a progressive neurodegenerative disorder impacting patients and healthcare systems.
• Lecanemab, an amyloid-beta targeting monoclonal antibody, is approved for early-stage AD, offering disease-modifying potential.
• This study evaluates Lecanemab's real-world outcomes in early AD patients at Tel Aviv Medical Center.

Purpose of the Study:

• To assess the demographic characteristics, treatment response, and safety of Lecanemab in early AD patients.
• To analyze 6-month follow-up outcomes, including cognitive function and amyloid-related imaging abnormalities (ARIA).
• To contribute real-world evidence for optimizing clinical practice with disease-modifying AD therapies.

Main Methods:

• Prospective study of early AD patients treated with Lecanemab since November 2023.
• Data collection included demographics, ApoE4 status, CSF and plasma biomarkers, and Mini-Mental State Examination (MMSE) scores.
• Monitoring for ARIA and cognitive assessment at 6-month follow-up for patients completing the visit by January 2025.

Main Results:

• 45 patients completed 6-month follow-up; mean age 73, 53% female, 51% ApoE4 carriers.
• Mean MMSE score declined by 1.47 points (p=0.009) over 6 months; younger patients (<75) showed significant decline (p=0.007).
• 15.5% developed asymptomatic ARIA-H; plasma p-tau181 correlated with baseline MMSE (r=-0.429, p=0.023).

Conclusions:

• Lecanemab treatment showed a potential for cognitive preservation in early AD over 6 months.
• The incidence of ARIA was lower than reported in clinical trials, suggesting a favorable safety profile in this cohort.
• Real-world data is crucial for guiding clinical decisions regarding Lecanemab and other disease-modifying therapies for AD.