What’s that study? The Generation Program
We caught up with Professor Lefkos Middleton from Imperial College London, who is UK Chief Investigator for the Generation Program.
The Generation Program is a collaboration between Novartis, Amgen and Banner Alzheimer’s Institute, and consists of two clinical trials that may be able to delay the onset of Alzheimer’s disease – Generation Study 1 and Generation Study 2.
What are the main aims of these studies?
Research shows a link between a substance called amyloid beta and Alzheimer’s disease. These studies will investigate whether experimental medications are able to impact on amyloid in the brain and whether this can delay the onset of symptoms.
That’s why we need people with a specific genotype which may increase the risk of developing Alzheimer’s.
Who can take part? (eligibility criteria)
We’re looking for people who are:
- aged 60-75 years
- do not show any signs or symptoms of Alzheimer’s Disease
- have a specific form of a gene (APOE4) which may increase the risk of developing the disease.
Not everyone will have this gene. Potential volunteers will need to have a quick cheek swab test to see if they are eligible for the trial.
If you have this gene, it doesn’t mean you will develop Alzheimer’s, but it does mean you may be at higher risk.
This genetic link means that if any of your relatives have Alzheimer’s, you may have a greater chance of being eligible to participate in the Generation Program.
What do the studies involve for a participant?
If you do take part, you will be given an investigational treatment or a placebo and asked to attend regular visits to your local study site (see below). There will be 8 visits in the first year, and 4 visits per year from then on. This is so we can run tests to measure the safety and potential effectiveness of the treatments.
During the trial, you’ll also need to have a study partner. The study partner does not have to be your spouse or child, but they must agree to accompany you on at least twice-yearly visits, and they must spend enough time with you to be familiar with your overall behaviours. They should have a good knowledge of your domestic activities, hobbies, social skills, basic daily life, and general health.
How long is the study for?
Each of the studies will last for 5-8 years. While that may seem like a long time, your contribution could advance medical knowledge in the fight against Alzheimer’s and benefit generations to come.
What do you hope the outcomes of the study will be?
The aim of Generation Program is to evaluate treatments that could potentially delay Alzheimer’s. While it’s too early to determine the success of ongoing research, every study contributes to the body of knowledge that brings us closer to finding an effective treatment.
Where is the study based?
The Generation Program is recruiting around the world, and currently has the following active sites in the UK:
You can see if you are eligible for this study or others around the UK by logging into your Join Dementia Research account.
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