Status:

COMPLETED

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

Lead Sponsor:

OPKO Health, Inc.

Collaborating Sponsors:

Elan Pharmaceuticals

Conditions:

Down Syndrome

Eligibility:

All Genders

18-45 years

Phase:

PHASE2

Brief 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 enrol...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

September 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

23 Patients enrolled

Trial Details

Trial ID

NCT01791725

Start Date

September 1 2013

End Date

June 1 2014

Last Update

November 4 2019

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of California, San Diego

La Jolla, California, United States, 92093-0949

2

University of California, Irvine

Orange, California, United States, 92868

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114