Clinical Trial: Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With

Brief Summary: The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome. Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.

Detailed Summary:
Sponsor: Eisai Inc.

Current Primary Outcome: Vineland-II Adaptive Behavior Scale (VABS-II); Parent/Caregiver Rating Form (PCRF) [ Time Frame: Screen, Baseline, Week 4 and Week 10 or Early Termination. ]

Original Primary Outcome: Vineland-II Adaptive Behavior Scale (VABS-II); Parent/Caregiver Rating Form (PCRF) [ Time Frame: Screen, Baseline, Week 24 and Week 10 or Early Termination ]

Current Secondary Outcome: The Test of Verbal Expression and Reasoning (TOVER); Population PK (drug levels in the body), PD (drug effects) and safety will also be assessed. [ Time Frame: Baseline, Week 4 and Week 10 or Early Termination. ]

Original Secondary Outcome: The Test of Verbal Expression and Reasoning (TOVER). Population PK (drug levels in the body), PD (drug effects) and safety will also be assessed. [ Time Frame: Screen, Baseline, Week 24 and Week 10 or Early Termination ]

Information By: Eisai Inc.

Dates:
Date Received: December 6, 2007
Date Started: December 2007
Date Completion:
Last Updated: August 4, 2009
Last Verified: August 2009