The TREM2 agonistic antibody AL002 in early Alzheimer's disease: a phase 2 randomized trial - PubMed
3 days ago
- #Alzheimer's disease
- #TREM2
- #clinical trial
- Phase 2 randomized trial of TREM2 agonistic antibody AL002 in early Alzheimer's disease (AD).
- 381 participants with early AD were randomized to receive AL002 (15 mg/kg, 40 mg/kg, or 60 mg/kg) or placebo every 4 weeks for 48-96 weeks.
- AL002 showed sustained target engagement and pharmacodynamic responses in the central nervous system, including reductions in soluble TREM2 and increases in osteopontin in cerebrospinal fluid.
- Primary endpoint (change in Clinical Dementia Rating-Sum of Boxes score vs. placebo) was not met at week 96 (P > 0.05).
- Most frequent adverse events were MRI changes resembling amyloid-related imaging abnormalities (ARIA).
- First trial of a TREM2 agonistic antibody in early AD was negative but provides insights for future TREM2 therapeutics and ARIA research.