Trial record 2 of 6 for:    ELND005

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Elan Pharmaceuticals
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier:
NCT01791725
First received: February 6, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Down Syndrome
Drug: ELND005
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 4-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2a Safety and PK Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of adverse events (TEAE, SAE) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Changes from Baseline in physical and neurological examinations [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma ELND005 concentrations [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    ELND005 PK profile to optimize PK model including patient population


Other Outcome Measures:
  • Cognitive Outcome [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Rapid Assessment for Development Disabilities (RADD)

  • Functional Outcomes [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Vineland Adaptive Behavior Scale, Second Edition (VABS-II)


Estimated Enrollment: 24
Study Start Date: September 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ELND005 BID
ELND005 250 mg BID
Drug: ELND005
Experimental: ELND005 QD
ELND005 250 mg QD
Drug: ELND005
Placebo Comparator: Placebo
Placebo BID
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791725

Contacts
Contact: Patrick Kesslak, Ph D 415-590-0078 patrick.kesslak@elan.com

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093-0949
University of California, Irvine Recruiting
Orange, California, United States, 92868
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Elan Pharma International Limited
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier: NCT01791725     History of Changes
Other Study ID Numbers: ELND005-DS201
Study First Received: February 6, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dementia
Down Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 31, 2014