NCT00675025

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

An Open-label Study to Evaluate the Safety of Donepezil Hydrochloride((Aricept®) 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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DRUG	Donepezil hydrochloride (Aricept)	Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.

Timeline

• Start date: 2008-04-04
• Primary completion: 2008-11-13
• Completion: 2008-12-15
• First posted: 2008-05-08
• Last updated: 2021-03-29
• Results posted: 2021-03-29

Locations

31 sites across 1 country: United States