Study With Lu AF20513 in Patients With Mild Alzheimer's Disease
Research type
Research Study
Full title
Interventional open-label, multiple-immunization study of the immunogenecity, pharmacodynamics and safety of Lu AF20513 in patients with mild Alzheimer's disease or Mild Cognitive Impairment due to Alzheimer's disease
IRAS ID
249788
Contact name
Catherine Mummery
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2018-002600-14
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 11 months, 5 days
Research summary
Alzheimer’s disease(AD) is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. Approximately 35.6 million people worldwide have dementia and 60-70% is due to AD.
Lu AF20513 is a vaccine that is being developed to be used in the treatment of mild AD or mild cognitive impairment (MCI) due to AD. In patients diagnosed with AD, plaque (clusters of protein fragments) composed mostly of a substance called beta amyloid (a protein) build up in the brain and have been shown to play an important role in the development of the disease. The long-term build-up of plaque can result in memory failure, personality changes, and problems carrying out daily activities. Lu AF20513 is expected to stimulate the immune system to produce specific antibodies (proteins that help fight and protect against diseases) that target and remove the beta amyloid. This treatment could potentially change the underlying disease process in AD.
The purpose of this study is to investigate the safety and effect of different doses and dosing regimens (schedule of doses over time) of Lu AF20513 on the antibody response to beta-amyloid and its accumulation in patients with AD or MCI due to AD. Approximately 10 hospital sites will participate in the study and the target is to recruit 28 patients.
The study will consist of a Screening, Treatment, and Follow-up Period. This study will be about 44 weeks (Screening Period of 8 weeks, Treatment Period of 24 weeks, and Follow-up Period of 12 weeks).
The study will include 4 cohorts (groups), patients are put into different cohorts. The results are compared to see if certain doses and regimens are better than others.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0217
Date of REC Opinion
8 Mar 2019
REC opinion
Unfavourable Opinion