Study TRX-005 was designed to assess the safety and efficacy of LMTX® at two doses in 800 patients diagnosed with mild 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 200mg per day given for up to 18 months

This 18-month study took place at 98 clinical sites in 12 countries. All 800 subjects were randomized but 1 site was removed from the study for compliance reasons, reducing the intent-to-treat population to 795 of which:

The modified intent-to-treat population (all patients taking the drug and having at least one post-baseline efficacy assessment) was 761 and the overall retention rate was 66%.

The results were published in the Journal of Alzheimer’s Disease in November 2017