TRAILBLAZER-ALZ 6
Research type
Research Study
Full title
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults with Early Symptomatic Alzheimer’s Disease
IRAS ID
1007069
Contact name
Rebecca Sitbon
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2022-502268-18
Research summary
Early symptoms of Alzheimer’s disease (AD) include a small but clear decline in memory, thinking, language and judgment skills. Individuals with AD have elevated levels of a toxic protein called a beta amyloid protein in their brain, which is the recognised “hallmark” for AD.
Trailblazer-ALZ 6 is a randomized, double-blind, Phase 3b study in adults with early symptomatic AD. Early symptomatic AD refers to the combination of 2 stages, mild cognitive impairment and mild AD dementia. Donanemab is an anti-amyloid antibody that removes amyloid plaques in the brain. Trailblazer-ALZ 6 is a new clinical research study testing how different donanemab doses compare in their safety and effectiveness in treating people with AD.
The study duration will be up to approximately 1 year 9 months and will include a screening period followed by a treatment period, and a posttreatment follow-up visit. Approximately 800 participants will be randomly assigned to 1 of 4 treatment arms. All participants will receive a dosing regimen that includes donanemab, but at different dose levels and frequency of dosing.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0014
Date of REC Opinion
28 Apr 2023
REC opinion
Further Information Favourable Opinion