This is a phase 1b, randomized, double-blind, placebo-controlled study, in which patients with early AD will receive a single intrathecal dose of NIO752.~A total of 24 participants will be enrolled into one of two cohorts (each with 12 participants) and randomized into receiving one dose of NIO752 or placebo in 2:1 ratio.~Participants will remain in this study for a 170-day follow-up period including approximately 3 in-clinic visits.~Cohorts will be enrolled sequentially.~Study assessments will include pharmacokinetics (PK), physical and neurological examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, and urinalysis), CSF routine laboratory test, adverse event, and serious adverse event monitoring.
Phase 1b study to assess the pharmacodynamics, safety, tolerability, and pharmacokinetics of NIO752 in patients with early Alzheimer's disease (AD)