A Pilot Study to Evaluate the Effect of CT1812 Treatment on A-beta Oligomer Displacement into CSF in Subjects with Mild to Moderate Alzheimer's Disease

Cognition Therapeutics is developing an oral formulation of CT1812 to treat AD and mild cognitive impairment. This is a multi-center, Phase 1b, randomized, double-blind, placebo-controlled parallel-group trial in adults with mild to moderate AD, sponsored by the NIH. The primary purpose of this study is to evaluate target engagement of CT1812 treatment by measuring the displacement of AB oligomers into cerebrospinal fluid (CSF). Target population is 50-85 year olds with mild to moderate Alzheimers Disease Dementia; must be able to provide own consent and must have a caregiver willing to accompany to all visits. Subjects will be randomized in a 2:1 (active:placebo) ratio and admitted inpatient (CTRC) for a Confinement Visit that will take place over 2 days, consisting of four phases: admission, 24-hour CSF and plasma sampling, 6-hour period of observation, and discharge. Participants will have CSF and plasma sampling for 3 hours prior to drug administration and then for 24 hours post-drug administration. Up to 18 subjects will be enrolled; interim analyses will be conducted after first 6 and next 6 to assess dosage of CT1812 and to determine if there is sufficient evidence of oligomer displacement to continue full trial with all 18 subjects.