Lead Investigator: Dr Paul Edison
Institution: Imperial College London
Grant type: Project
Duration: 3 years
Amount: £338,525 contribution to larger trial
Scientific Title: Evaluating the effects of the novel GLP-1 analogue, Liraglutide, in patients with Alzheimer's disease (ELAD) study
What do we already know?
There is a connection between type 2 diabetes and Alzheimer's disease; people with type 2 diabetes are much more likely to develop Alzheimer's disease than healthy people of the same age group.
Recently, a drug used to treat type 2 diabetes, called liraglutide, has shown promise for the treatment of Alzheimer's disease. In laboratory studies it improves symptoms of Alzheimer's and reduces the amount of amyloid plaques in the brain, a hallmark of the disease.
What does this project involve?
In this study, the researchers are going to test the effect of liraglutide in people with Alzheimer's disease, to see whether the drug has positive effects on brain function and cognition.
The clinical trial will recruit participants from around the country who have been diagnosed with Alzheimer's disease and are still considered to be in the early stages. Each participant will receive either liraglutide or a placebo treatment, via injection, for one year. Their brain will be scanned at the start of the experiment and after 12 months to look for changes in brain glucose, inflammation and brain volume, all indicators of Alzheimer's. Participants will also undergo cognitive tests to assess whether the drug has an effect on memory and thinking.
This trial is a Phase 2b trial which means that in addition to patient benefits, it will test for side-effects of the drug in people with Alzheimer's disease.
Update: During the trial, people receiving liraglutide reported a perceived change in their symptoms after they stopped taking the drug. Therefore, at the end of the 12 month clinical trial, all participants will be offered the opportunity to join a 12 month open-label extension trial. All participants in this trial will receive liraglutide treatment, even if they were on the dummy drug (placebo) in the original trial. This will allow the researchers to study the long-term effects of using liraglutide to treat Alzheimer’s disease.
How will this benefit people with dementia?
Alzheimer's Society initially funded a pilot clinical trial of liraglutide but, following our initial investment, Dr Paul Edison was able to raise money from additional sources to fund a much larger trial. The additional investment comes from a range of sources, including the pharmaceutical company that makes the drug, Imperial College London and nurse support from the NHS.
The study is now a clinical trial that will involve ten times more participants than originally planned. If successful, this means the drug could become available as a treatment for Alzheimer's much sooner.
Moreover, as liraglutide is currently licensed for diabetes, it has already passed through large parts of the drug development process. This makes it much cheaper and faster to develop as a new Alzheimer's treatment than it would for novel drugs. Using existing treatments in this way is called drug re-purposing and forms the basis of our Drug Discovery programme.
If the trial is successful, liraglutide could become a new treatment for Alzheimer's within the next 5-10 years, benefitting many of the estimated 500,000 people living with Alzheimer's disease in the UK, as well as many more around the world and in the future.
Who can take part?
This trial is recruiting participants with early-stage Alzheimer's disease (MMSE score of 22 or higher) in the following areas: London, Brighton, Southampton, Swindon, Oxford, Birmingham and Cambridge. More recruitment sites across the country will be opening soon.