Principal Investigator:

Dr Joseph Kane         

Name of the Study: RewinD-LB

A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)

Why is this Study important?

Dementia with Lewy Bodies (DLB) represents up to 15-20% of the dementia population, it can be more severe than other dementia disorders including Alzheimer’s disease yet there are currently no approved therapies and a limited number of drugs in development specifically for DLB. If effective this drug has the potential to make a significant advance in the treatment for people with DLB.

What is the Research question/aim?

The primary objective is to demonstrate the efficacy of a new drug called neflamapimod against a placebo as a treatment for Dementia with Lewy Bodies. The secondary objective is to determine whether this drug can improve how people remember and their thinking ability, how good they are at performing day-to-day tasks and motor function.

What the Study involves:

Please note that this study is closed to recruitment. Interested people will be assessed to check if they are eligible to take part. They will undergo a health check and blood tests, and also given some memory tests to assess their ability to think and remember. Their family member or friend will also be asked some questions as to how well the research participant is able to carry out day to day activities. The research drug, or a dummy drug called a placebo, will be given over a 16-week treatment period, during which time participants are followed up to check for safety and monitor any changes in memory, thinking and functioning.

Who can take part in the Study?

The recruitment phase for this study has ended. People aged 55 or over with a diagnosis of Dementia with Lewy Bodies and is able to complete a number of cognitive assessments. They must also have a family member or friend that is willing to take part in the study with them.

Contact Information:

Eileen Fox Clinical Research Nurse 

eileen.fox@belfasttrust.hscni.net 

Tel 028 961 56010