* Donanemab in Early Symptomatic Alzheimer’s Disease
Research type
Research Study
Full title
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease
IRAS ID
295620
Contact name
Josephine Emer MacSweeney
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2020-000077-25
Duration of Study in the UK
3 years, 6 months, 12 days
Research summary
Dementia is a group of related symptoms associated with an ongoing decline of brain functioning. Alzheimer's disease (AD) is the most common type of dementia in the UK. The exact cause of AD is not yet fully understood, although a number of factors are thought to increase your risk of developing the condition including increasing age and family history. AD is a progressive condition, where symptoms develop gradually and eventually become more severe. It affects multiple brain functions.
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. Donanemab is an antibody that targets and removes deposited amyloid plaques.
The study TRAILBLAZER-ALZ 2 will assess if removal of existing plaques using donanomab can slow the progression of the disease in patients with early symptomatic AD. Trial participants must be 60 to 85 years of age, report gradual and progressive change in memory function over at least 6 months, meet mini-mental state examination clinical score criteria, and test positive for the presence of abnormal proteins in the brain as determined by positron emission tomography (PET) imaging. Study participants will receive either donanemab or placebo intravenously every 4 weeks. Patient participation is expected to last up to 127 weeks including 72 weeks of treatment. Approximately 1500 patients will be enrolled globally including approximately 100 trial participants from the UK.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0152
Date of REC Opinion
21 Apr 2021
REC opinion
Further Information Favourable Opinion