A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
- Registration Number
- NCT01791725
- Lead Sponsor
- OPKO Health, Inc.
- 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 enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 18 - 45 years of age
- Has an IQ of > 40 (K-BIT)
- Able and willing to have a brain MRI
- Symptoms of dementia or worsening cognition over the past year.
- Has a history of hepatitis B, hepatitis C, or HIV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ELND005 QD ELND005 ELND005 250 mg QD Placebo Placebo Placebo BID ELND005 BID ELND005 ELND005 250 mg BID
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (TEAEs) 4 weeks For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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
University of California, San Diego🇺🇸La Jolla, California, United States