Phase 2
N=23
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
Down Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01791725 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Incidence of Adverse Events (TEAEs) — 5; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ELND005 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- OPKO Health, Inc.
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (TEAEs) |
5; 2; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 - 45 years of age
- Has an IQ of > 40 (K-BIT)
- Able and willing to have a brain MRI
Exclusion Criteria
- Symptoms of dementia or worsening cognition over the past year.
- Has a history of hepatitis B, hepatitis C, or HIV
Data sourced from ClinicalTrials.gov (NCT01791725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.