Completed

DS201A 4-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2a Safety and PK Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ELND005

+ ELND005

+ Placebo

Drug
Who is being recruted

Congenital Abnormalities+7

+ Abnormalities, Multiple

+ Intellectual Disability

From 18 to 45 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2013
See protocol details

Summary

Principal SponsorOPKO Health, Inc.
Last updated: November 4, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01791725
Principal SponsorOPKO Health, Inc.
Last updated: November 4, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesAbnormalities, MultipleIntellectual DisabilityCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsNeurobehavioral ManifestationsChromosome DisordersGenetic Diseases, InbornDown Syndrome

Criteria

3 inclusion criteria required to participate
18 - 45 years of age
Able and willing to have a brain MRI
Has an IQ of > 40 (K-BIT)
2 exclusion criteria prevent from participating
Has a history of hepatitis B, hepatitis C, or HIV
Symptoms of dementia or worsening cognition over the past year

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
ELND005 250 mg BID

Group II

Experimental
ELND005 250 mg QD

Group III

Placebo
Placebo BID

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

University of California, San Diego

La Jolla, United StatesOpen University of California, San Diego in Google Maps

University of California, Irvine

Orange, United States

Massachusetts General Hospital

Boston, United States
Completed3 Study Centers