TRx-237-005 Clinical Study
This clinical trial will assess the safety and efficacy of LMTX™ in up to 700 patients diagnosed with mild Alzheimer’s Disease. 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:
- The Alzheimer’s Disease Assessment Scale – Cognitive Subscale, known as ADAS-cog11
- The Modified Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change, known as ADCS-CGIC
The treatment period is 18 months and the study, which is placebo-controlled, is taking place at over 100 clinical sites, primarily in the US and EU. The study is fully recruited and results are expected in the second half of 2016.