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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO Health, Inc.; Transition Therapeutics Ireland Limited
• Collaborator: Elan Pharmaceuticals

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