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

NCT01791725 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-11-04

Study results available
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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.

Conditions

  • Down Syndrome

Interventions

DRUG

ELND005

DRUG

Placebo

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY

  • OPKO Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01791725 on ClinicalTrials.gov