Clinical trials across Greater Manchester are underway to investigate an existing medicine as a disease-modifying option for early-stage Alzheimer’s disease.
The Evoke trial is a global study looking into the effects of the drug, semaglutide, on early-stage Alzheimer's disease. Greater Manchester Mental Health NHS Foundation Trust (GMMH) is leading on the delivery of the trial in Greater Manchester and will be recruiting people to take part in this clinical trial locally.
The Pharmaceutical company testing this drug, Novo Nordisk, will also be working alongside Join Dementia Research – a national registry – and dementia clinics, to find people aged 55 - 85 with a diagnosis of Mild Cognitive Impairment (MCI) or early-stage Alzheimer’s disease.
For this phase 3 clinical trial, researchers are recruiting through Join Dementia Research - a national registry – and clinics, to find people aged 55 - 85 with a diagnosis of Mild Cognitive Impairment (MCI) or early Alzheimer’s disease.
If eligible, patients in the trial will be given either semaglutide or a dummy medicine (known as a placebo) and asked to take one tablet a day. As this is double-blind randomised controlled trial, neither the patients nor the researchers will know who has the active medicine and who has the placebo.
All patients will receive regular clinic visits, health checks and medical testing. They will have access to expert guidance and facilities during the study.
It is hoped that 3500 participants globally will take part over a three-year period.
Dr Ross Dunne, Lead Researcher for the Evoke Trial at Greater Manchester Mental Health NHS Foundation Trust (GMMH), and Specialty Lead for Dementias and Neurodegeneration research at the National Institute for Health and Care Research (NIHR) Clinical Research Network Greater Manchester, said:
“Semaglutide is one of a host of medications already licensed for other conditions which may play a role in reducing the progression of early Alzheimer’s and other early-stage diseases’ underlying dementia.
“The advantage of such re-purposed medications is that they have already been trialled by thousands of people. Our aim is to recruit as many people as possible in Greater Manchester who have mild cognitive impairment (MCI) or early-stage Alzheimer Dementia to investigate the effects of this medication.”
The study’s Chief Investigator Professor Naji Tabet of Brighton and Sussex Medical School said:
“This phase 3 trial will give us an accurate picture of the medicine’s efficacy and safety profile in people living with early Alzheimer’s disease.
“We will measure the impact by comparing cognition tests taken at the start and end of the study and by collecting regular information about our patients’ health, cognition, ability to perform daily activities and general wellbeing.”
“I would encourage anyone with early Alzheimer’s disease or mild cognitive impairment to consider taking part in this study.”
Semaglutide is an investigatory medicine and is not licensed for the treatment of early Alzheimer’s disease.
Participants will need to:
- Take one tablet every day
- Perform memory tests and questionnaires on how well they manage daily routines
- Provide blood samples at ten of the clinic visits.
- Undergo 1 brain MRI or CT scan to look at brain structure *
- Undergo 1 PET brain scan or a spinal tap to test for amyloid (a protein involved in Alzheimer’s disease) *
- Have a study partner (someone to accompany them to appointments)
* Patients will have the opportunity to discuss the results of these scans with their study doctor before taking any medication.
Anyone who is interested in taking part should sign up to Join Dementia Research and if they are eligible, a member of the study team will contact them.