During the Clinical Trials on Alzheimer's Disease (CTAD) conference in San Francisco (USA), the company TauRx Therapeutics Ltd presented the top line results from the LUCIDITY phase III trial for the treatment of Alzheimer’s disease (AD). The phase III LUCIDITY trial is a randomised placebo-controlled study aimed at people with Mild Cognitive Impairment (MCI) due to AD and mild to moderate dementia due to AD. In this trial, the participants are randomly assigned to the test group or the control group. While the control group receives a placebo, the test group receives hydromethylthionine mesylate. This oral compound, also known as HMTM, is a Tau Aggregation Inhibitor (TAI) with a strong safety profile. Unlike other clinical trials aim to target the amyloid protein in this disease, TauRx’s LUCIDITY is the only late-stage clinical trial focused on the use of TAIs to prevent the formation of the so-called tau tangles. These are thought to damage nerve cells responsible for memory and have been suggested to correlate with disease severity and brain atrophy.
The LUCIDITY phase III trial has two parts with a duration of 12 months each, aimed at demonstrating that HMTM therapy is effective in delaying the clinical (signs and symptoms) and pathological (brain changes) progression of the disease. During the first part, which consists of a double-blind treatment period (i.e., neither the participants nor the researchers know who is receiving a particular treatment), HMTM was only administered to the test group at a dose of 16 mg/day. The second part of the trial is open-label (i.e., researchers and participants know the treatment given) and all the participants receive HMTM at a dose of 16 mg/day. Based on previous data shared by TauRx in October 2022, the LUCIDITY trial shows an improvement in cognition over the pre-treatment baseline, at a dose of 16 mg/day of HMTM in participants with MCI due to AD. This improvement has, additionally, shown to be sustained over 18 months. Further data of the open-label extension is ongoing and expected in mid-2023.
For more information, see these links: https://taurx.com/news-insights/taurx-announces-results-from-phase-3-alzheimers-disease-study-lucidity-assuring-path-for-regulatory-submissions
Alzheimer Europe has previously reported on the results from this trial, on 6 October 2022. Read our earlier article, here: https://www.alzheimer-europe.org/news/taurx-announces-results-its-lucidity-phase-iii-trial-ad