A team of researchers at the Imperial College of London is studying Liraglutide, a drug that stimulates insulin secretion. Liraglutide is already approved as a treatment for type 2 diabetes. Researchers believe that it will “feed the brain,” increasing synapse plasticity, recognition index and stem cell proliferation, aiding the brain’s ability to retain and recall memories.
Through the support of some high quality organizations and charities, Imperial College has already started its work! The trial is underway and making significant progress – but they need the Give To Cure community to help get them over the finish line. Thanks to these supporters, this trial requires less than $1 million to move the ball forward on a viable cure for Alzheimer’s.
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Researchers believe that Alzheimer’s Disease causes tissue loss and nerve cell death throughout the brain. As the disease gets worse, brain tissue actually shrinks, harming the areas that control memory, language, comprehension, and other important functions that we recognize as symptoms of Alzheimer’s Disease.
The study will administer a drug, (Liraglutide, a GLP-1 receptor agonist) which was originally developed and licensed for the treatment of type 2 diabetes, to patients with mild AD. The drug was originally developed to increase glucose levels – which has a nourishing effect on the brain. Researchers think it can slow AD progression and prevent cognitive and functional deterioration by growing brain tissue that is thought to hold memory; the same tissue that we see decrease over time in an Alzheimer's patient.
This is a Phase IIb Trial. It will last 36 months in total and its estimated conclusion date is early 2018. It is studying 237 patient diagnosed with Early Stage Alzheimer’s Disease (AD) (anticipates 15% drop-out rate) and each of them is being followed for 12 months. The treatment will be administered via a self injector device, identical to how it is administered for current diabetes patients worldwide.
Studies have proven that brain matter growth is key in stopping the symptoms of AD and dementia. Unfortunately, until now, the only effective way to do that was through dangerous procedures (including the injection of new man made viruses), making those treatments non-viable for millions of AD patients.
Our trial has substituted insulin as a growth agent, which is not only easier and safer to produce and manipulate, but it is easier to deliver to patients. Insulin delivery is expected to improve several of the main biomarkers seen in early AD patients. Past studies on this drug’s interaction with the brain shows not only an increase in fatty tissue, but also synapse plasticity, recognition index and stem cell proliferation, all of which aid the brain’s ability to retain and recall memories. And the best part? Dr. Edison’s team is delivering the treatment an insulin pen! Millions of people use an insulin pen ever day which means that this is one of the easiest treatments to administer at home.
This Study Uses an Existing FDA-Approved Drug:
In the drug development process, safety is a major hurdle on the way to approval. Here we are purposing an existing FDA-Approved drug which has already been through extensive testing and use in human subjects. Therefore, chances of it being approved are greatly increased and concerns around the safety of the drug are significantly decreased.
Imperial College was established in 1907 by the Royal Charter and is consistently ranked one of the top universities in the world and is a major biomedical research center with the first academic health center in the United Kingdom. Imperial faculty and alumni include 15 Nobel Laureates, 2 Field Medalists, 70 Fellows of the Royal Society, and 78 Fellows of the Academy of Medical Sciences.
The study is being led by Dr Edison, a Clinical Senior Lecturer in the Division of Brain Sciences at Imperial College London and a visiting Professor at Cardiff University, Wales. He is also a Consultant Physician at Hammersmith Hospital, London.
He leads the Imperial College Memory Research centre, and is the chief investigator of several imaging studies using PET and MRI, and heads multicentre studies evaluating novel treatment of Alzheimer's and other neurodegenerative diseases. He also runs a memory clinic at Imperial College Healthcare NHS Trust
Dr Edison’s research has focused on neuroimaging with novel molecular probes using PET and magnetic resonance techniques for imaging patho physiological changes associated with Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative diseases. He has extensive experience in PET imaging in different neurodegenerative and neuroinflammatory conditions. Combined with his clinical expertise in different types of degenerative diseases and dementia, he has investigated the relationship between amyloid deposition, microglial activation, and glucose metabolism indifferent disorders, along with evaluating different transporters in the brain. His work in assessing microglial activation and amyloid load showed that both these are increased in Alzheimer’s disease, and microglial activation correlates with cognition, while amyloid load does not correlate with cognition. He was an MRC clinical research fellow before he became a HEFCE clinical senior lecturer.
His work now focuses on neuroinflammation, and the interplay between inflammation and immunity in neurodegenerative and neuroinflammatory disease, and relating these with genetic information. He is also evaluating the methods of modulating inflammation and amyloid in Alzheimer’s disease, and the influence of cardiometabolic factors on the development of neurodegenerative diseases by means of clinical and pre-clinical studies.
If Liraglutide is safe, why do we need a clinical trial? Why can’t my doctor just prescribe it right now?
Repurposed drugs significantly accelerate the drug timelines but it doesn’t eliminate the need for clinical trials altogether. Though the compound is proven safe in diabetes patients, clinical trials are required to determine the correct dosage, frequency, and most effective way to administer the drug for Alzheimer’s Disease patients . In addition to testing the overall efficacy of the compound, testing these parameters are just as important in developing an effective drug regimen.
Is Liraglutide safe in non-diabetic individuals?
Yes, Liraglutide has been extensively tested and is well tolerated. It does not cause hypoglycaemia in non-diabetic individuals.
What are the side effects of Liraglutide?
The most common adverse events observed were related to the gastrointestinal organ system with the most frequently reported adverse event being nausea. The majority of these events were of mild or moderate severity and transient in nature, being most frequent in the early part of the treatment.