The AMARANTH Study
A 24-month, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer’s Disease
Duration of Study in the UK
2 years, 0 months, 0 days
Alzheimer’s Disease (AD) is a progressive and fatal disorder of the nervous system, which results in amyloid plaque formation in specific regions of the brain, which is associated with inflammation and loss of neurones and synapses. Amyloid plaques are a build-up proteins clumped together. AD is characterised by memory loss and progressively impairs activities of daily living.
Beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1) is involved in the formation of amyloid plaques in AD. BACE1 is therefore considered to be a promising therapeutic target for slowing down or halting disease progression in AD.
BACE1 splits amyloid precursor protein (APP) into a group of peptide fragments, which are the main component of the amyloid plaques. The study drug AZD3293 is an inhibitor of BACE1 and has been shown to reduce peptide fragments in mice, rats, guinea pigs, dogs, and humans. The study is being done to test whether AZD3293 modifies the clinical course of Alzheimer’s disease (AD) by delaying disease progression in patients diagnosed with early AD.
This is a multicentre randomised, double-blind study which will take place across 15 countries and approximately 1551 patients will be recruited worldwide from up to 175 centres. Two thirds of patients will receive the study drug and one third will receive a placebo placebo (an injection solution containing no drug) on top of their current therapy.
This study is sponsored by AstraZeneca. It is anticipated that participants will remain in the study for up to 2 years.
London - Chelsea Research Ethics Committee
Date of REC Opinion
29 Jan 2015
Further Information Favourable Opinion