Eli-Lilly 8D-MC-AZET Delayed Start study in Mild AD (DAYBREAK)
Research type
Research Study
Full title
Protocol I8D-MC-AZET A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer’s Disease Dementia (The DAYBREAK Study)
IRAS ID
206641
Contact name
J. Emer MacSweeney
Contact email
Sponsor organisation
Eli Lilly & Company
Eudract number
2015-005625-39
Duration of Study in the UK
4 years, 7 months, 19 days
Research summary
The purpose of the study is to find out whether the study drug LY3314814 (AZD3293)has the potential to be a helpful treatment that slows down disease progression in research participants diagnosed with early Alzheimer’s Disease (AD, which is defined as a mild cognitive impairment (MCI by comparing it to placebo (inactive medication). This study will enrol patients with mild dementia of the AD type.
Alzheimer’s disease is a progressive and fatal neurodegenerative disease manifested by cognitive deterioration in addition to progressive impairment of activities of daily living. 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.
This study is a multi-centre, randomised, parallel-group, 78-week double-blind, placebo-controlled, study of 2 fixed doses of LY3314814 in patients with mild AD dementia and abnormal levels of amyloid, followed by a 78-week Delayed-Start period.
by comparing it to placebo (inactive medication).
There are 4 treatment arms. The randomisation ratio is 2:2:1:1 (LY3314814 20 mg: LY3314814 50 mg: Placebo for 78 weeks then LY3314814 20 mg; Placebo for 78 weeks then LY3314814 50 mg). The three treatment groups in the 78-week Placebo-Controlled period include 2 fixed doses of LY3314814 (20 mg or 50 mg) or placebo. In the 78-week Delayed-Start period, there are the same 2 fixed doses of LY3314814 (20 mg or 50 mg) and all patients previously on placebo will then initiate either dose of LY3314814 based on their randomisation.
This study is sponsored by Eli Lilly and approximately 3800 participants will be screened to achieve 1899 randomised for an estimated total of 633 evaluable participants per treatment group (633 in combined placebo arms during Placebo-Controlled period).REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1297
Date of REC Opinion
16 Sep 2016
REC opinion
Further Information Favourable Opinion