A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | June 2014 |
A 4-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2a Safety and PK Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
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.
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.
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
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