A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

  • STATUS
    Recruiting
  • End date
    Aug 29, 2024
  • participants needed
    1566
  • sponsor
    Eisai Inc.
Updated on 29 April 2021

Summary

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

Description

All infusion will be administered in the clinic; However, home infusions will be allowed per sponsor approval according to country and local guidelines during the COVID-19 pandemic and following its resolution, where permitted.

Details
Condition Alzheimer's Disease
Clinical Study IdentifierNCT03887455
SponsorEisai Inc.
Last Modified on29 April 2021

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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