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This excerpt taken from the ELN 6-K filed Dec 15, 2009. About ELND005
(AZD-103)
ELND005
is an orally-administered therapeutic agent that has received fast track
designation from the U.S. Food and Drug Administration (FDA) for treatment of
mild to moderate Alzheimer's disease. Fast track designation can facilitate
development and may expedite regulatory review of drugs that the FDA recognizes
as potentially addressing an unmet medical need for serious or life-threatening
conditions.
ELND005
is currently in a Phase 2 clinical study, which completed enrollment in October
2008. The study is a randomized, double-blind, placebo-controlled, dose-ranging,
safety and efficacy study in approximately 353 patients with mild to moderate
Alzheimer's disease. The planned treatment period for each patient is
approximately 18 months.
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