A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia (DS201)

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OPKO Health

Status and phase

Completed
Phase 2

Conditions

Down Syndrome

Treatments

Drug: Placebo
Drug: ELND005

Study type

Interventional

Funder types

Industry

Identifiers

NCT01791725
ELND005-DS201

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

23 participants in 3 patient groups, including a placebo group

ELND005 BID
Experimental group
Description:
ELND005 250 mg BID
Treatment:
Drug: ELND005
ELND005 QD
Experimental group
Description:
ELND005 250 mg QD
Treatment:
Drug: ELND005
Placebo
Placebo Comparator group
Description:
Placebo BID
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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