Study TRX-007 was designed as a double-blind, placebo-controlled study to evaluate the safety and efficacy of LMTX® in patients with behavioural variant frontotemporal dementia (bvFTD). The study compared 200 mg/day with 8 mg/day and aimed to confirm in a larger, 12-month controlled clinical trial the results previously seen.
The main measures of efficacy used in the study were the change in study subjects’ performance at the beginning and the end of the study in two commonly used clinical assessments:
In addition, the study assessed efficacy via the reductions seen in whole brain volume as measured by MRI.
This 12-month study took place at 69 clinical sites in 12 countries. Of the 220 subjects randomized:
The modified intent-to-treat population was 214 and the overall retention rate was 74%.
This is the largest reported randomised controlled trial in bvFTD subjects carried out to date and TauRx reported results for the first time at the 10th International Conference on Frontotemporal Dementias (ICFTD), 31 August-2 September 2016. There is at present no treatment available in bvFTD, TauRX intends to further investigate LMTX® in this indication.