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news.Amarin has received the necessary regulatory and ethical approvals to commence a Phase IIa trial in age associated memory impairment with AMR101.
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The Phase IIa trial will be a randomized, double-blind, placebo-controlled study. The trial will enroll 96 patients with age associated memory impairment (AAMI) who will be randomized to receive one, two or four grams of AMR101 or placebo twice daily over a six-week period.
Efficacy will be assessed by a computerized battery of cognition tests designed by Cognitive Drug Research, a provider of innovative cognitive function assessment technology. The study is being conducted in the UK and patient recruitment is expected to commence shortly, with initial results expected in the second half of 2008.
Declan Doogan, head of R&D at Amarin, said: “AMR101 has already demonstrated promising positive effects in classical preclinical models of memory and cognition.”