ABERDEEN, Scotland and Singapore, 21st April 2021, TauRx is delighted to announce that the phase 3 clinical trial, Lucidity (TRx-237-039), which aims to evaluate our anti-tau investigational drug in people with mild cognitive impairment and mild-moderate Alzheimer’s disease (AD), is now fully randomised. Top line results of the trial are expected in mid-2022.
Professor Claude Wischik, CEO of TauRx said “Completing randomisation for the Lucidity trial is an important milestone in our quest to confirm the efficacy of LMTM, and we recognise the incredible work of the teams involved in reaching this point in unprecedented circumstances. Exceeding our initial target for patient numbers by around 20 percent is testament to the interest in testing tau-based alternatives to drugs targeting amyloid which have been largely unsuccessful so far. The network of esteemed neurological and psychiatric colleagues, patient advocacy groups and people with AD all share a desire to find an effective treatment for this devastating disease, which affects an estimated 50 million people worldwide. We are extremely grateful for their ongoing support. We hope to be able to announce top line trial results some time in Q2 2022.”
The trial, with sites in the UK, North America, Canada, Spain, France, Italy and Poland, uses well accepted cognitive and functional assessment scales to confirm the potential benefits seen with our drug in delaying the progression of Alzheimer’s disease, and includes an open-label phase during which all participants will receive the drug.
Alzheimer's disease is a progressive neurological disease of the brain that causes damage to neurons, leading to loss of memory and reasoning. It is the leading cause of dementia worldwide and is the world's greatest unmet medical need.
Randomisation is now complete across 76 trial sites globally, with recruitment exceeded by ~20 percent. Lucidity is the only late-stage clinical trial targeting the Tau pathology of Alzheimer’s.