An Extension Study of ABBV-8E12 in Early Alzheimer’s Disease (AD)

Overview

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with early AD.

Full Title of Study: “An Extension Study of ABBV-8E12 in Early Alzheimer’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 14, 2026

Interventions

  • Drug: ABBV-8E12
    • ABBV-8E12 solution for IV infusion

Arms, Groups and Cohorts

  • Experimental: ABBV-8E12 Dose 1
    • Participants will receive ABBV-8E12 Dose 1.
  • Experimental: ABBV-8E12 Dose 2
    • Participants will receive ABBV-8E12 Dose 2.

Clinical Trial Outcome Measures

Primary Measures

  • Adverse Events
    • Time Frame: From first dose of study drug to 20 weeks after last dose of study drug (up to approximately 5.5 years)
    • Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 20 weeks after discontinuation of study drug.

Secondary Measures

  • Clearance of ABBV-8E12
    • Time Frame: From first dose of study drug to 20 weeks after last dose of study drug (up to approximately 5.5 years)
    • Clearance (CL) of ABBV-8E12.
  • Volume of distribution (V)
    • Time Frame: From first dose of study drug to 20 weeks after last dose of study drug (up to approximately 5.5 years)
    • Volume of distribution.

Participating in This Clinical Trial

Inclusion Criteria

  • All subjects with early AD who complete Study M15-566 (NCT02880956), meet all inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment – Subject was compliant during participation in Study M15-566 (NCT02880956) – Subject has an identified, reliable study partner who has frequent contact with the subject and who will provide information as to the subject's cognitive and functional abilities Exclusion Criteria:
  • The subject has any significant change in his/her medical condition since participation in Study M15-566 (NCT02880956) that could interfere with the subject's participation in Study M15-570, could place the subject at increased risk, or could confound interpretation of study results – More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-566 (NCT02880956) – The subject is concurrently enrolled in another interventional clinical study involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)
  • Gender Eligibility: All

    Minimum Age: 57 Years

    Maximum Age: 87 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • AbbVie
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • AbbVie Inc., Study Director, AbbVie

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