U.S. multicenter, parallel group study designed to evaluate the safety and efficacy of oral
20 mg twice daily (BID) NE3107 vs placebo in 316 adult subjects with mild to moderate AD. Two
coprimary outcome measures (the Alzheimer's Disease Assessment Scale Cognitive Subscale 12
[ADAS Cog12] and the Alzheimer's Disease Cooperative Study Clinical Global Impression of
Change [ADCS CGIC] will be evaluated as the change from Baseline to Week 30. Secondary
endpoints include measures of neuropsychological deficits, functional performance, and
glycemic control. A subset of patients may volunteer for exploratory magnetic resonance
imaging (volumetric changes) and positron emission tomography (cortical glucose metabolic
rate) scans at baseline and week 30.