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 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; 220 subjects were randomised.
This is the largest reported randomised controlled trial in bvFTD subjects carried out to date. There is at present no treatment available in bvFTD.