Alzheimer’s drug study restarts
An Alzheimer’s drug study is restarting after being paused earlier this year. The CLARITY study is examining whether the drug BAN2401 can be effective in preventing or delaying the very early stages of Alzheimer’s disease.
Alzheimer’s disease affects approximately 26 million people worldwide and current medications only provide a temporary improvement in symptoms.
The study is open to men and women aged 50-90 who have a diagnosis of early-stage Alzheimer’s disease or mild cognitive impairment and a specific memory test score in the mild range.
This is a Phase 3 trial, which is designed to confirm the effectiveness of BAN2401, found in earlier trials, in a much larger study being conducted in many countries across the world. Since there is no licensed ‘standard of care’ drug to compare with, participants will receive either BAN2401 or placebo, given as a short infusion into a vein every two weeks with regular clinic visits occurring over a total of two years. The infusions can be given at the research clinics or they can be received at home.
Before treatment begins, everyone will undergo a screening process so that only those who actually require treatment, take part in the study. This involves tests such as memory tests, physical examinations, blood samples and brain scans to determine if the participant’s condition meets requirements to participate.
The sponsor for the study, Eisai Ltd, is offering an extension to the main study to allow all people who complete the study to receive the active study medication. This means that even if volunteers were originally given placebo, they will be given BAN2401 as part of the extension period.
How to get involved
Dr Stuart Ratcliffe, Chief Scientific Officer at St Pancras Clinical Research in London and National Coordinating Investigator for CLARITY said: “We are really pleased that our study is re-starting, CLARITY is recruiting until March 2021 and there are research centres in London, Southampton, Sheffield, Guildford, Birmingham and Plymouth, so hopefully we can recruit well throughout the country.”
To find out more, visit the ClinicalTrials.gov website or call 0203 865 1142.