TauRx has been carrying out clinical trials on its experimental compounds for several years. We are currently conducting a global Phase 3 clinical trial, called LUCIDITY. In collaboration with neurologists and clinical research centres in North America and Europe, this trial has been designed to test the efficacy of our lead compound after previous trial results established a concentration-dependent pharmacological action at low dose. We expanded this trial to provide for a broader range of patients to be eligible, including those with mild cognitive impairment due to Alzheimer’s disease, mild and moderate Alzheimer’s disease.
The trial uses well accepted cognitive and functional assessment scales to assess the potential effects of our drug, reference as TRx023-039, as well as using MRI scans to review the impact on the rate of brain atrophy, which is commonly seen in people with dementia. After the first 12 months of comparing participants on drug versus those on placebo, all participants will have access to the drug during a 12 month open-label phase.
Patients completing the full trial may also be eligible for continued use of the drug under an Expanded Access Programme pending any regulatory outcomes.
Patient safety is our highest priority, and we work closely with all trial sites to maintain this especially in view of the Covid-19 pandemic.
TauRx has previously completed three separate Phase 3 trials: two in Alzheimer's disease and one in the rare neurodegenerative disorder, behavioural variant Frontotemporal Dementia (bvFTD).