This study is in progress, not accepting new patients

A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

a study on Alzheimer's Disease Dementia Brain Diseases Central Nervous System Diseases Cognitive Impairment

Summary

Eligibility
for people ages 60-90 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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 assessments.

Official Title

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

Keywords

Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Cognitive Impairment, Nervous System Diseases, donanemab

Eligibility

You can join if…

Open to people ages 60-90

  • 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

You CAN'T join if...

  • 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 study.
  • Poor venous access
  • Contraindication to PET or MRI imaging

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT04640077
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 90 people participating
Last Updated