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A 4-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2a Safety and Pharmacokinetic Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks. Safety (eg, AEs, neurological and physical examination findings, vital signs,ECGs, and clinical laboratory testing) of patients will be monitored throughout the study.
The objectives of the study are to evaluate the safety of ELND005 and to determine the population PK model and relationship between PK parameters, safety outcome measures,and exploratory efficacy outcome measures in young adults with Down's Syndrome without dementia.