TRx-237-015 Clinical Study
This clinical trial will assess the safety and efficacy of LMTX™ in up to 833 patients diagnosed with mild to moderate Alzheimer’s. The main measures of efficacy to be used in the study are:
- The change in study subjects’ performance at the beginning and the end of the study in two commonly used clinical assessments:
a. The Alzheimer’s Disease Assessment Scale – Cognitive Subscale, known as ADAS-cog11
b. The Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, known as ADCS-CGIC
2. The safety and tolerability of LMTX™ given for up to 15 months
The treatment period is 15 months and the study, which is placebo-controlled, is taking place at over 100 clinical sites in North America, the EU, Russia, Australia and Asia. The study is fully recruited and results are expected in the first half of 2016.