NCT01791725

A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

A 4-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2a Safety and PK Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DRUG	ELND005
DRUG	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-02-15
• Last updated: 2019-11-04
• Results posted: 2016-01-29

Locations

3 sites across 1 country: United States