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ClinicalTrials.gov Identifier: NCT03712787

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

    Status Enrolling by invitation
    Related Conditions
    Alzheimer's Disease

Enrollment Details

400 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M15-570

Brief summary

Top

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

Participant Attributes :
  • Male and Female
  • Ages 57 to 87 years old

Canada: 3

0
Vancouver, BC
1
London, ON
2
Toronto, ON
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
    ?

    Allocation

    Non-Randomized

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
    ?

    Masking

    Quadruple insu (sujet / aidant / chercheur / examinateur)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
    ?

    Purpose

    Treatment

  •  

    • 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

     

    • 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)

More on this trial

Clinical Trials.gov