The initial stage of the trial will assess the bioavailability of a single-dose oral suspension in 16 healthy elderly subjects. The second stage will be a randomized, double-blind, placebo-controlled evaluation of safety, tolerability, and cognitive effects in approximately 120 subjects with age-associated memory impairment (AAMI) over four weeks. This stage is anticipated to include three groups of 40 subjects each, exploring two dose levels with a placebo control. The second stage will evaluate the safety and tolerability of LX6171 oral suspension in subjects exhibiting AAMI and will measure the cognitive effects of LX6171 in these subjects using the cognitive drug research battery, along with other psychometric instruments. The study is being conducted in Europe, with initial results expected by the end of 2008.
LX6171 is an orally-bioavailable small molecule developed to inhibit a membrane protein expressed exclusively in the central nervous system and found at synaptic vesicles and presynaptic membranes of glutamatergic neurons.
Philip Brown, vice president of clinical development at Lexicon, said: “Following the strength of the Phase I data indicating LX6171 is generally well tolerated, we have adopted a two-stage strategy for Phase IIa in order to transition to our new oral suspension formulation and to assess for improvements in a variety of cognitive dimensions as we enter the elderly population.”