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

Completed · Phase 2 · Has a placebo group

Conditions studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT01791725

Run by

OPKO Health, Inc.

People needed

23

Starts

2013-09-01

Expected to finish

2014-06-01

Last updated by the study team

2019-11-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 - 45 years of age
• Has an IQ of > 40 (K-BIT)
• Able and willing to have a brain MRI

You may not qualify if…

• Symptoms of dementia or worsening cognition over the past year.
• Has a history of hepatitis B, hepatitis C, or HIV

Where it is running

• University of California, San Diego — La Jolla, California, United States
• University of California, Irvine — Orange, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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