An international clinical trial is set to offer an experimental Alzheimer's drug to healthy middle-aged individuals who are deemed to be at a higher risk of developing the condition. The trial aims to determine if the drug can prevent dementia symptoms from emerging.
The PrevenTRON study, a phase III trial, will investigate whether Trontinemab can stop dementia from developing in participants with elevated levels of the p-tau217 biomarker. Previous research suggests this biomarker can predict cognitive decline and Alzheimer's development, with high levels indicating an estimated 78% chance of cognitive impairment within 10 years.
The Surrey and Borders Partnership NHS foundation trust will screen the first European participants on Monday. The trial is recruiting around 1,600 people aged 55 to 80 from across the world. Participants will undergo memory checks and blood tests for p-tau217.
Trontinemab, developed by Swiss pharmaceutical company Roche, works by attacking amyloid plaques, a protein that builds up in the brain. Early research indicated it cleared amyloid plaques in nine out of 10 people with early-stage Alzheimer's or mild cognitive development within 28 weeks.
Prof Ramin Nilforooshan, chief investigator for the PrevenTRON trial, highlighted the shift in research focus from treatment after symptoms appear to earlier prevention. He stressed the experimental nature of Trontinemab, stating, "It's an investigational medicine. We need to wait and see: will it work or not?"
At least 15 UK hospitals and clinics are expected to participate in the study by the end of the year. The trial is anticipated to last four to six years, with participants randomly assigned to receive either Trontinemab or a placebo and then monitored for signs of dementia.