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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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