Generation 2 - CNP520 in participants at risk of Alzheimer’s
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer’s Disease (AD)
IRAS ID
241430
Contact name
Lefkos Middleton
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-002976-28
Duration of Study in the UK
6 years, 6 months, 25 days
Research summary
The aim of the study is to test whether a new medicine can delay or prevent Alzheimer’s disease in healthy people aged 60 to 75 years.
Alzheimer’s disease is the most common type of dementia. People with Alzheimer’s disease slowly lose their ability to remember events, find places, communicate and take care of themselves until eventually it causes death. It generally affects older people and some people may be at higher risk of developing the disease, depending on the genes (DNA) they inherit from their parents. There are no treatments available today to delay or prevent Alzheimer’s disease.
The new medicine has been shown to reduce the amount of a substance (a protein) in the brain called Amyloid Beta. Unusually high amounts of Amyloid Beta have been found in the brains of people with Alzheimer’s disease. It is thought that by reducing the amount of amyloid beta in the brain, the development of Alzheimer’s disease in people can be delayed or even prevented.
People who take part in the study will have normal memory for their age and be willing to take a genetic test. People who have two copies of the APOE4 gene will be offered the chance to enter the main part of the study where they will receive a capsule to take by mouth once a day. People who have one copy of the APOE4 gene and have increased levels of Amyloid Beta will be offered the chance to enter the main part of the study where they will receive a capsule to take by mouth once a day. Some participants will receive a placebo which is a capsule that looks identical to the new medicine but does not contain any active ingredient.
During the study participants will visit a research site near them every 3 months and have tests to check their memory/thinking, answer questions about their health and have biological samples (e.g blood) taken for testing. In addition participants will have brain scans at the start and be invited for further brain scans during the treatment period along with having their heart monitored a few times during the study. A person who is familiar to participant (for example a husband or wife) will need to come to the visits every 6 months to answer some questions about the participant’s health.People who receive their genetic results and do not have at least one copy of the APOE4 gene will not receive the new medicine.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0099
Date of REC Opinion
23 Apr 2018
REC opinion
Further Information Favourable Opinion