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INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease

Article: The Journal of Prevention of Alzheimer’s Disease.

The Phase 1 INTERCEPT-AD study evaluated sabirnetug (ACU193), a monoclonal antibody targeting amyloid-beta oligomers (AβOs), in participants with early symptomatic Alzheimer’s disease (AD). The study involved 65 participants and aimed to assess safety, pharmacokinetics, and exploratory measures.

Key Findings:

  • Safety: Sabirnetug was generally well tolerated, with mild-to-moderate adverse events. Some participants developed mild amyloid-related imaging abnormalities (ARIA).
  • Pharmacokinetics: The drug showed dose-related and dose-proportional exposure, with minimal accumulation.
  • Target Engagement: Sabirnetug effectively bound to AβOs in the cerebrospinal fluid (CSF), with higher doses showing greater engagement.
  • Amyloid Plaque Reduction: Higher doses led to significant reductions in amyloid plaques as observed through PET imaging.
  • Cognitive Efficacy: No significant changes in cognitive assessments were noted over the study period.

The study provided valuable data for the design of the Phase 2 ALTITUDE-AD study, suggesting that sabirnetug may help clear multiple forms of amyloid-beta and potentially impact the AD pathological process.

Author(s): Eric Siemers, Todd Feaster, Gopalan Sethuraman, Karen Sundell, Vladimir Skljarevski, Erika N. Cline, Hao Zhang, Jasna Jerecic, Lawrence S. Honig, Stephen Salloway, Reisa Sperling, Mirjam N. Trame, Michael G. Dodds , Kimball Johnson

Year: 1월 1, 2025

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