TRx-237-005 Clinical Study
This clinical trial will assess the safety and efficacy of LMTX™ in up to 500 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 will be 18 months and the study, which will be placebo-controlled, is planned to take place at approximately 60-70 clinical sites primarily in the US and EU and is expected to last for 2½-3 years.
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