Study TRX-015 was designed to assess the safety and efficacy of LMTX® at three doses in 891 patients diagnosed with mild to moderate Alzheimer’s disease. The main measures of efficacy (“primary outcomes”) used in the study were:

  1. The change in study subjects’ performance in two commonly used clinical assessments:
    1. The Alzheimer’s Disease Assessment Scale – Cognitive Subscale, known as ADAS-cog11
    2. The Modified Alzheimer’s Disease Cooperative Study – Activities of Daily Living, known as ADCS-ADL
  1. The safety and tolerability of LMTX® at doses of 150mg and 250mg per day given for up to 15 months were compared with a dose of 8mg per day

This 15-month study took place at 116 clinical sites in 16 countries. Of the 891 subjects randomized:

The modified intent-to-treat population (all patients taking the drug and having at least one post-baseline efficacy assessment) was 855 and the overall retention rate was 65%.

The results were published in The Lancet in November 2016.