Lundbeck/Otsuka initiate Phase III trial for Lu AE 58054 in Alzheimers disease
Lundbeck and Otsuka are now initiating the phase III program for Lu AE 58054, which is planned to include four trials. Several doses of Lu AE 58054 ranging from 10-60 mg will be used in combination with donepezil in order to explore the effect of Lu AE58054 in mild-to-moderate Alzheimer's disease as adjunctive therapy to acetylcholinesterase inhibitors (AChEls). The key endpoints are Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog), Activities of Daily Living (ADL), and the Clinical Global Impression of Change Scale (CGIC).
The program will enroll approximately 3,000 patients. The first trial will enroll 930 patients in the U.S., Canada and 15 other countries mainly in Europe, and is expected to last up to three years.
Blocking the 5-HT6 receptor in the brain can stimulate the release of dopamine and norepinephrine in the frontal cortex, offering a new approach to treating the memory-destroying disease.
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