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

PHASE3TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

November 30, 2008

Study Completion Date

December 31, 2008

Conditions
Down SyndromeCognitive Dysfunction
Interventions
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.

Trial Locations (2)

20170

Neuroscience, Inc, Herndon

78258

Road Runner Research, San Antonio

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Eisai Inc.

INDUSTRY