drugset / Trial / NCT00570128

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

NCT00570128

Phase 2 Completed 129 enrolled Eisai Inc. Pfizer · collab
RandomizedParallel-groupDouble-blindTreatment

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 (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.

Timeline

Start
2007-11-16
Primary completion
2008-09-05
Completion
2008-09-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Donepezil Small molecule 2.5 mg Oral
Comparator Donepezil Small molecule 5 mg Oral
Comparator Donepezil Small molecule 10 mg Oral

Indications