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      ACU193, a Monoclonal Antibody that Selectively Binds Soluble Aß Oligomers: Development Rationale, Phase 1 Trial Design, and Clinical Development Plan.

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          Abstract

          Alzheimer's disease is a large and growing unmet medical need. Clinical trial designs need to assess disease-related outcomes earlier to accelerate the development of better treatments for Alzheimer's disease. ACU193 is a monoclonal antibody that selectively targets amyloid β oligomers, thought to be the most toxic species of Aβ that accumulates early in AD and contributes to downstream pathological effects. Nonclinical data indicate that ACU193 can reduce the toxic effects of amyloid β oligomers. ACU193 is currently being investigated in a phase 1 clinical trial designed with the properties described in this report. This phase 1 trial is designed to provide data to enable a go/no-go decision regarding the initiation of a subsequent phase 2/3 study.

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          Author and article information

          Journal
          J Prev Alzheimers Dis
          The journal of prevention of Alzheimer's disease
          SERDI
          2426-0266
          2274-5807
          2023
          : 10
          : 1
          Affiliations
          [1 ] Eric Siemers, Acumen Pharmaceuticals, Inc., 11711 N. Meridian St., Ste. 310, Carmel, IN 46032, USA, esiemers@acumenpharm.com.
          Article
          10.14283/jpad.2022.93
          36641606
          ef650da0-6c40-44f9-bc90-ac881ea89182
          History

          arterial spin labeling,Alzheimer’s disease therapeutics,Aβ oligomers,computerized cognitive battery,monoclonal antibody,phase 1 trial design

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