News Releases
Completion of the Early Phase II Clinical Study of "Epadel" for Alzheimer's Disease
(Tokyo, December 12, 2005) - Mochida Pharmaceutical Co., Ltd. (President: Naoyuki Mochida,) announces the completion of its Clinical Early Phase II Study of "Epadel" (ehyl icosapentate ) for patients with Alzheimer's disease (AD). The study commenced in April 2003.
Epidemiologic investigations suggest that the omega-3 fatty acids EPA and DHA have beneficial effects on brain functions such as memory retention. Mochida developed this pilot study to investigate potential efficacy of "Epadel", an acclaimed medication for the treatment of hyperlipidemia, in patients with AD. Since AD exacerbates progressively, efficacy is evaluated by whether a drug inhibits the disease's progression. Thus, while early trials generally use a single administration, this study was conducted as a placebo-controlled study. Dosage was limited to 1,800 mg/day as a standard dose in the treatment of hyperlipidemia.
While the study has only recently been completed and the results are still being given detailed analysis, thus far it can be said that, from the results of all the patients, the expected decline in cognitive function among the placebo group was not observed, and no apparent difference between the placebo group and the Epadel group was recognized. Moreover, in terms of general improvement, there was no significant difference, however there were more patients exhibiting some improvement among the Epadel group.
To determine the future development path, individual patients should be fully examined, and review of the protocol and the necessity of an increase in dosage should be considered.