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Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer’s Disease With Validation of Remote Neuropsychological Assessments


Brief Summary:

The main goals of this study are to further determine whether the study drug donanemab is
safe and effective in participants with Alzheimer’s disease and to validate video scale


Inclusion Criteria:

– Participated in a double-blind treatment period of a sponsor-approved originating
donanemab trial, for example the TRAILBLAZER-ALZ study.

– Have a study partner

– Stable symptomatic Alzheimer’s Disease (AD) medications and other medication that may
impact cognition for at least 30 days prior to randomization into Part A

Exclusion Criteria:

– 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 outcome assessments or the analyses in
this study.

– Have received treatment with a passive anti-amyloid immunotherapy after completion of
originating donanemab study or received active immunization against Aβ in any other

– Poor venous access

– Contraindication to PET or MRI imaging


  • Irvine Clinical Research, Irvine, California, United States, 92614
  • UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND), Irvine, California, United States, 92697
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