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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01791725
Other study ID # ELND005-DS201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2013
Est. completion date June 2014

Study information

Verified date October 2019
Source OPKO Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ELND005

Placebo


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States University of California, San Diego La Jolla California
United States University of California, Irvine Orange California

Sponsors (2)

Lead Sponsor Collaborator
OPKO Health, Inc. Elan Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes From Baseline in Abnormal Neurological Examination Results Subjects with Abnormal Neurological Examination Results Baseline and 4 weeks
Other Pharmacokinetic Assessment Mean Plasma ELND005 Concentrations- Cmax Baseline and 4 Weeks
Other Cognitive Outcome (RADD Total Score) Rapid Assessment for Development Disabilities (RADD) The RADD test was developed from the low-difficulty items from published intelligence tests (Walsh et al 2007). It was specifically developed for evaluation of individuals with intellectual disabilities and developmental disabilities. It is a validated and reliable cognitive screening instrument that can be rapidly administered. The RADD is composed of 76 items. Each item is scored as 0 (incorrect) or 1 (correct).The test assesses a wide range of functional abilities including receptive and expressive language, orientation, registration, recall, attention, self identification, motor skills, imitation, abstract reasoning, number skills, comprehension and short-term memory to give a total score. Scores are from 0 to 76. A higher total score is correlated with a higher Cognitive Impairment level. Baseline and 4 Weeks
Other Improvement in NPI Total Scores in Subjects With NPI Score =1 at Baseline Baseline The Neuropsychiatric Inventory(NPI) (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia patients. The NPI was administered at the Baseline Visit (Day 1) and at Day 28 (EOS) or ET. A decrease in score shows an improvement in symptoms. Baseline and 4 weeks
Primary 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. 4 weeks
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