A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

  • End date
    Dec 19, 2023
  • participants needed
  • sponsor
    Eli Lilly and Company
Updated on 26 September 2021
positron emission tomography
mini-mental state examination
alzheimer's disease


The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.

Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.

Condition Dementia, Alzheimer's Disease, alzheimer, dementia alzheimer's type, Alzheimer Disease
Treatment Placebo, Donanemab
Clinical Study IdentifierNCT04437511
SponsorEli Lilly and Company
Last Modified on26 September 2021


Yes No Not Sure

Inclusion Criteria

Gradual and progressive change in memory function reported by participants or informants for 6 months
MMSE score of 20 to 28 (inclusive) at baseline
Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
Meet 18F florbetapir PET scan (central read) criteria
Have a study partner who will provide written informed consent to participate

Exclusion Criteria

Contraindication to MRI or PET scans
Current treatment with immunoglobulin G (IgG) therapy
Clear my responses

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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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