NCT00754052

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17

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 Down Syndrome, Aged 11 To 17

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, aged 11 to 17.

Detailed description

The study will be conducted in approximately 75 sites in the US, India, Singapore, South Korea, Mexico and Chile and will include 210 participants to be enrolled.

Conditions

• Down Syndrome
• Cognitive Dysfunction

Interventions

Type	Name	Description
DRUG	Aricept (donepezil hydrochloride)	All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalation will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally.
DRUG	Aricept (donepezil hydrochloride)	All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) donepezil. All doses will be administered orally.
DRUG	Placebo	All participants will start with a dose of 2.5 mg/day (2.5 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) placebo. All doses will be administered orally.

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-09-17
• Last updated: 2018-04-23
• Results posted: 2018-04-23

Locations

2 sites across 1 country: United States