Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome – Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

Overview

The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

Full Title of Study: “An Open-label Study to Evaluate the Safety of Donepezil Hydrochloride((AriceptĀ®) for up to 1 Year in the Treatment of Cognitive Dysfunction Exhibited by Children With Down Syndrome-Follow-up to a 10-Week,Double-Blind,Placebo-Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 13, 2008

Detailed Description

All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.

Interventions

  • Drug: Donepezil hydrochloride (Aricept)
    • Liquid form Aricept – 5 mg/5 mL donepezil hydrochloride.

Arms, Groups and Cohorts

  • Experimental: Prior Donepezil-DB
    • All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant’s weight schedule and the Investigator’s judgment of safety and tolerability. Re-titration was done to maintain the blinding of the double-blind study (E2020-A001-219). Doses could be decreased due to tolerability and could be increased or decreased to maintain a maximum dose of 0.1 to 0.2 mg/kg/day based on the participant’s weight at clinic visits during the study duration.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Visit 1 (Baseline) to Visit 4 or Early Termination in the Vineland Adaptive Behavior Scales, 2nd Edition, Parent/Caregiver Rating Form (VABS-II/PCRF) Sum of the 9 Sub-domain V-scores
    • Time Frame: Visit 1 (baseline); Early Termination Visit (Week 36)
    • VABS-II/PCRF assessed participant’s adaptive behaviors on 3 domains (each has 3 sub-domains): Communication (receptive, expressive, written), Daily Living Skills (personal, domestic, community), Socialization (interpersonal relationships, play a leisure time, coping skills). Parent/caregiver rated participant’s behavior for sub-domains from 0 (never present) to 2 (always present). Raw scores from sub-domains converted into standardized score(V-scale scores) ranged:1-24 for each sub-domain, mean=15,standard deviation(SD)=3,higher scores=higher level of adaptive functioning and were summed to obtain V-scale composite score ranged 9-216, mean=100,SD=15,higher scores=higher level of adaptive functioning, positive change=improvement in adaptive functioning. Composite and individual analyses, both raw and standardized scores, were not performed due to lack of significant differences between donepezil and placebo in parent study.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of Down syndrome (established during study E2020-A001-220). – Completion of study E2020-A001-219 (NCT00570128 [also known as A2501059]) with no ongoing seroius adverse events and no severe drug reactions. Exclusion Criteria:

  • Weight less than 20 kg. – Clinically significant conditions affecting absorption, distribution or metabolism of the study medication. – No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study. – Females of childbearing potential who are not practicing an effective means of birth control.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Inc.
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor

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