A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Alzheimer's Disease
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Age: Between 60 - 85 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Provide written consent
- Gradual and progressive change in memory function reported by the participant or informant for =6 months
- Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
- Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Stable concomitant symptomatic AD medications and other medication that may impact cognition
You may not be eligible for this study if the following are true:
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- Significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study
- Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator’s opinion, could interfere with the analyses in this study
- History of cancer
- Participants with any current primary psychiatric diagnosis other than AD
- Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
- History of alcohol or drug use disorder
- History of clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions
- Have any contraindications for MRI
- Sensitivity to florbetapir F18 or flortaucipir F18
- Poor venous access
- Contraindication to PET
- Present or planned exposure to ionizing radiation
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.