Investigating the impact of anti-inflammatory drugs on Alzheimer’s disease
A research study exploring the impact specialist anti-inflammatory drugs have on Alzheimer’s disease symptoms is looking for volunteers in London, Plymouth, Guildford and Southampton.
The EXploratory PLatform trial on Anti-INflammatory agents in Alzheimer’s Disease, or EXPLAIN-AD for short, will be evaluating the effectiveness and safety of anti-inflammatory agents on common Alzheimer’s symptoms – including memory, cognition (learning, remembering and using knowledge), and other behavioural and psychiatric symptoms. It will also be measuring the impact these agents have on inflammation levels in the brain.
EXPLAIN-AD is aiming to build on increasing evidence which indicates inflammation in the brain may be closely linked to the diagnosis of Alzheimer’s disease and can lead to the condition getting worse. Published in the Journal of Alzheimer’s Disease in 2020, research on a cytokine agent found in the brain that encourages inflammation suggests inflammation appears to play an integral role in the initial development of Alzheimer’s.
The study team is hoping to uncover which drugs are most effective for managing inflammation in the brain. If there is a link between inflammation of the brain and Alzheimer’s disease, this could prove to be vital information for potential treatments.
Benefits of taking part
Professor Clive Holmes, EXPLAIN-AD’s chief investigator, said: “Alzheimer’s disease is one of the highest unmet medical and societal needs. Our research team believes that inflammation in the brain causes brain cells to die and is the main reason why people with Alzheimer’s disease get the disease, and also why they get worse.
“The drugs we are testing are already approved treatments for several diseases associated with inflammation, so we are hoping to show they can also reduce inflammation in the brain and slow down the progression of Alzheimer’s.”
Selected participants and their study partners will be involved in the study for just over nine months after they have registered their interest. This is made up of a screening period lasting approximately two months, and a study period following this.
All participants will be randomly assigned to receive either the anti-inflammatory study treatment drug, or the placebo (dummy drug). The drug or placebo will be given via injection at the participant’s study visits once a month for six months.
There will also be regular questionnaires for participants and study partners to complete during their visits, and at home between visits. Participants will also be asked to complete a number of other assessments throughout the trial, including physical examinations, blood and urine tests and two lumbar punctures.
The study is open to everyone between the ages of 45 and 90 from London, Plymouth, Guildford and Southampton, who are showing early signs of a cognitive impairment as a result of an Alzheimer’s diagnosis. Each participant must also have a study partner who is willing to take part and attend appointments with them.
A study partner can be anyone who is in contact with the participant several times a week and can attend all study visits. We expect participants and their partners will visit their chosen study site at least 11 times during the study.
Please note – participants will be required to regularly visit one of our four study sites during the research programme, so they are advised to check they are able to travel to one of these sites before committing to the study.
Recruitment for this study will close between January and March 2023.
To find out if you are eligible to join this study, as well as other dementia studies, sign in to your Join Dementia Research account or if you are not already registered, sign up today.