On 11 April, the company TauRx Therapeutics Ltd announced it has completed patient randomisation for its Lucidity Phase III trial for the treatment of Alzheimer’s disease (AD). The Lucidity trial is a randomised, double-blind and placebo-controlled study evaluating the safety and efficacy of hydromethylthionine in people with AD encompassing mild cognitive impairment due to AD. Hydromethylthionine (which TauRx refer to under the chemical abbreviation, LMTM) acts by blocking abnormal accumulation of Tau protein in the brain. Lucidity is the only late-stage study targeting the tau pathology of AD.
The recruitment has exceeded the company’s initial target by around 20% and is now complete across 76 trial sites in US, Canada and Europe. All study participants have now been screened and randomised to received either oral capsules of hydromethylthionine (8 or 16 mg/day) or placebo twice daily for 52 weeks. The primary outcomes of the study are progression of cognitive decline and functional impairment over 12 months measured by standard clinical scales. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of the experimental drug, in which all participants will receive the drug. Top line results of the trial are expected in Q2 2022.
“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.”, said Professor Claude Wischik, CEO of TauRx
https://taurx.com/news-insights/taurx-announce-lucidity-trial-fully-randomised