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Phase III Trials Evaluate New Add-On Treatment for Alzheimer’s Disease

Therapy focuses on 5-HT6 receptor rather than on amyloid and tau proteins (October 10)

The first of four planned phase III clinical trials has been initiated to evaluate the investigational compound Lu AE58054 (Lundbeck/Otsuka Pharmaceutical Co.) for the treatment of Alzheimer’s disease (AD).

Lu AE58054 is a selective 5-HT6 (serotonin) receptor antagonist with a proposed mechanism of action that differs from that of currently available AD medications. According to the compound’s developers, a focus on the 5-HT6 receptor is a different approach from the amyloid and tau hypotheses that have underpinned much of the drug research on AD to date.

In the planned trials, several doses of Lu AE58054, ranging from 10 mg to 60 mg, will be used in combination with donepezil (Aricept, Eisai/Pfizer) to explore the effect of the compound in patients with mild-to-moderate AD as adjunctive therapy to acetylcholinesterase inhibitors (AChEls). The trials’ key endpoints are the Alzheimer’s Disease Assessment Scale—Cognitive Subscale (ADAS-cog), the Activities of Daily Living (ADL) scale, and the Clinical Global Impression of Change Scale (CGIC).

The clinical trial program will enroll a total of approximately 3,000 patients worldwide. The first study will include 930 patients in the U.S., Canada, and 15 other countries (mainly in Europe) and is expected to last up to 3 years.

Source: Lundbeck; October 10, 2013.

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