TRAILBLAZER-ALZ 5
Research type
Research Study
Full title
Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease
IRAS ID
1009252
Contact name
Eli Lilly
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
Early symptoms of Alzheimer’s disease (AD) can include subtle but noticeable changes in memory, thinking, language and judgement skills. Early symptomatic AD refers to the combination of 2 stages, mild cognitive impairment (MCI), and mild AD dementia due to AD. AD is thought to be caused by the abnormal build-up of proteins in and around brain cells. One of the proteins involved is called amyloid, deposits of which form plaques around brain cells. It is suggested that interventions that slow the accumulation of plaques in the brain or increase clearance of plaques may slow the progression of the AD clinical syndrome.
This study is a randomized (1:1), double-blind, placebo controlled, Phase 3 trial in adults with early symptomatic AD to evaluate the safety and efficacy of donanemab with presence of brain amyloid plaques and various levels of tau (the other altered protein involved in AD). Donanemab is an anti-amyloid antibody that targets and removes amyloid plaques in the brain. This study is testing how donanemab compares to placebo in treating people with early symptomatic AD.
The study duration will be up to approximately 93 weeks, the maximum duration of treatment is 72 weeks and will include a screening period followed by a treatment period, and a follow-up period. Participants will be randomised in a 1:1 ratio to one of the following treatment groups:
• Donanemab: 700mg IV every 4 weeks for the first 3 doses and then 1400mg IV every 4 weeks
• Placebo
Approximately 1500 participants will be enrolled globally, 170-200 in the UK.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
24/EE/0033
Date of REC Opinion
26 Mar 2024
REC opinion
Further Information Favourable Opinion