H8A-MC-LZAX: Progression of Mild Alzheimer’s Disease
Research type
Research Study
Full title
Effect of Passive Immunization on the Progression of Mild Alzheimer’s Disease: Solanezumab (LY2062430) Versus Placebo
IRAS ID
131441
Contact name
Roger Bullock
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2013-001119-54
Research summary
Alzheimer’s Disease (AD) is an age-related disorder characterised by a progressive decline in cognitive function and ability to perform activities of daily living, that ultimately can lead to death due to complications of the disease. Characteristics of AD identified at autopsy include the presence of beta-amyloid plaques in the brain.
The beta-amyloid hypothesis states that the production and deposition of beta-amyloid is an early and necessary event in AD development. Treatments that slow production or build up of beta-amyloid, or increase the body’s ability to remove it, might be expected to slow AD progression. One such approach is immunotherapy, which uses or mimics the body’s immune system to remove excess beta-amyloid protein. Immunotherapeutic approaches to slow AD progression include immunisation. Solanezumab is a monoclonal antibody being developed as a passive immunisation therapy for AD.
The purpose of this study is to find out whether Solanezumab, administered as an intravenous infusion at a dose of 400mg every 4 weeks for 76 weeks, will slow the mental and functional decline of AD in patients with a mild form of the disease when compared with placebo. This objective will be assessed using an analysis of two rating scales: 14-item AD Assessment Scale Cognitive subscale (ADAS-Cog14) and AD Cooperative Study Activities of Daily Living Inventory subset of items (items 7 to 23) for instrumental activities of daily living (ADCS-iADL). The study will also explore whether solanezumab has any effect on the underlying biology of AD.
Approximately 5250 patients with mild AD will be screened to take part in this study worldwide, with about 2100 entering the drug treatment part of the study. Approximately 70 patients will take part in the UK. This study is being funded by the pharmaceutical company Eli Lilly and Company and managed by the Contract Research Organisation Quintiles Ltd.
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0560
Date of REC Opinion
27 Sep 2013
REC opinion
Further Information Favourable Opinion