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

OPKO Health, Inc.23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Down Syndrome

Interventions

ELND005DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Incidence of Adverse Events (TEAEs)

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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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