AZFD - Study of LY3314814 in Early Alzheimer's Disease Dementia
Research type
Research Study
Full title
A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer’s Disease Dementia (Extension of Study AZES, The AMARANTH Study)
IRAS ID
221275
Contact name
Lefkos Middleton
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2016-003440-36
Duration of Study in the UK
3 years, 0 months, 9 days
Research summary
Alzheimer’s disease is a progressive (symptoms develop gradually and become more severe over the course of several years) which affects multiple brain functions including memory leading to impairment of activities of daily living. There is strong evidence that deposits of protein in the brain, called "amyloid plaques" and “neurofibrillary tangles" are involved in the development of the disease. These plaques and tangles can cause the brain to gradually work less well, and result in people having difficulties in thinking, learning and especially remembering things.
Current treatments are seen as minimally effective, with only minor symptomatic improvements for a limited duration, and they do not slow the progression of the disease. LY3314814 is being developed as a potential therapy for Alzheimer’s disease by slowing disease progression in patients diagnosed with early Alzheimer’s disease.
Study I8D-MC-AZFD is a multicenter, randomized, double-blind, 52-week delayed start study with 2 fixed doses of LY3314814 in patients diagnosed with early Alzheimer’s disease dementia, at the time of entry into feeder Study AZES (AMARANTH Study). The study will enrol approximately 1400 participants from the AZES study.
The treatment period of this study will begin at the end of visit 20 of the feeder study AZES and will continue with 52 weeks of treatment. Patients who were receiving either 20 mg or 50 mg of LY3314814 on Study AZES will continue on the treatment allocation from the feeder study. Patients who received placebo in Study AZES will be randomized in a blinded fashion 1:1 to LY3314814 20 mg or 50 mg daily (QD), administered orally.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0114
Date of REC Opinion
15 Jun 2017
REC opinion
Further Information Favourable Opinion