TRx-237-007 Clinical Study
In September 2012, TauRx announced the initiation of an international Phase 3 clinical trial in behavioural variant frontotemporal dementia (bvFTD). TRX-007 is a double-blind placebo-controlled study designed to evaluate the safety and efficacy of LMTX™, TauRx’s second-generation Tau Aggregation Inhibitor (TAI). The study aims to confirm the results first seen in pilot cases in a larger controlled clinical trial in bvFTD patients over a 52-week timeframe. The Phase 3 study is underway at ~70 study sites located in North America, EU, Australia, Singapore and Argentina. The study is fully recruited and study results are anticipated to be available in mid-2016.
The main measures of efficacy to be used in the study are the change in study subjects’ performance at the beginning and the end of the study in two commonly used clinical assessments:
- The Addenbrookes’s Cognitive Examination (Revised), known as ACE-R;
- The Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, known as ADCS-CGIC.
The treatment period is 12 months.