Conditions: Down Syndrome Cognitive Dysfunction
Keywords: Pediatric Down syndrome Downs Cognitive Dysfunction of Down syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Aricept (donepezil hydrochloride) intervention 2: Aricept (donepezil hydrochloride) intervention 3: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol document: