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:
- The change in study subjects’ performance in two commonly used clinical assessments:
- The Alzheimer’s Disease Assessment Scale – Cognitive Subscale, known as ADAS-cog11
- The Modified Alzheimer’s Disease Cooperative Study – Activities of Daily Living, known as ADCS-ADL
- 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:
- 549 (61%) had moderate AD and 342 (39%) had mild AD;
- 755 (85%) were taking LMTX® as an add-on therapy and 136 (15%) were taking LMTX® as monotherapy;
- 357 (40%) were randomized to the control arm (8 mg/day, given as 4 mg twice daily), 268 (30%) were randomized to the lower dose arm (150 mg/day, given as 75 mg twice daily) and 266 were randomized to the higher dose arm (250 mg/day, given as 125 mg twice daily).
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.