ClinicalTrials.gov ID- NCT05108922
Sponsor- Eli Lilly and Company
Study Start- 2021-11-16
Study Completion- 2023-09-19
Study Type- Interventional
Phase- Phase 3
This presentation is only used for educational purpose all rights preserved by Eli Lilly and Company
1. Presented By
Muhammad Kamal Hossain
Student ID- 202255221
School of Pharmacy
Jeonbuk National University (JBNU)
Presentation on-
Advancements in Alzheimer's Drug
Development: Insights from a Clinical
Trials (NCT- 05108922)
Course Name
New Drug Development and Clinical Trials
2. A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's
Disease (TRAILBLAZER-ALZ 4)
ClinicalTrials.gov ID- NCT05108922
Sponsor- Eli Lilly and Company
Study Start- 2021-11-16
Study Completion- 2023-09-19
Study Type- Interventional
Phase- Phase 3
11. A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early
Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
Why I select this study?
12.
13. A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early
Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
Official Title
A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance
With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic
Alzheimer's Disease
Conditions
Mild Cognitive Impairment (MCI)
Alzheimer's Disease (AD)
Alzheimer Disease
Intervention / Treatment
•Drug: Donanemab
•Drug: Aducanumab
Brief Summary
The main purpose of this study is to compare
donanemab to aducanumab on brain amyloid plaque
clearance in participants with early symptomatic
Alzheimer's Disease (AD)
Aducanumab, developed by Biogen, faced a complex
journey through clinical trials. Despite early setbacks and
uncertainties, the drug received considerable attention due
to its potential to target the underlying causes of
Alzheimer's disease. After initial mixed results, Biogen
announced in October 2019 that they would seek
regulatory approval for aducanumab based on new
analyses of additional data. However, in March 2019,
Biogen decided to discontinue the trials due to
ineffectiveness. But later, in June 2021, the U.S. Food and
Drug Administration (FDA) controversially granted
accelerated approval for aducanumab, now marketed as
Aduhelm, making it the first new treatment approved for
Alzheimer's disease in nearly two decades.
Is Donanemab FDA-
approved?
No. Lilly submitted its
traditional approval
application of donanemab
to the FDA and expects
action by early 2024.
14. Participation Criteria
Ref: Doraiswamy, P., Sperling, R., Johnson, K. et al. Florbetapir F 18 amyloid
PET and 36-month cognitive decline:a prospective multicenter study. Mol
Psychiatry 19, 1044–1051 (2014). https://doi.org/10.1038/mp.2014.9
Florbetapir F 18 amyloid PET and 36-month
cognitive decline: a prospective multicenter
study
35. In conclusion, the TRAILBLAZER-ALZ 4 trial comparing Donanemab (LY3002813) with Aducanumab in
individuals with early symptomatic Alzheimer's disease represents a significant step forward in our quest
for effective treatments. Through meticulous examination, the trial sheds light on the efficacy and safety
profiles of these promising therapeutic agents. While both drugs hold promise in targeting the underlying
pathology of Alzheimer's disease, further analysis and long-term follow-up are crucial to fully comprehend
their clinical implications. The insights gained from this trial offer valuable guidance for future research
endeavors and underscore the importance of continued efforts to advance our understanding and
management of Alzheimer's disease.
Concluding Remarks
