Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10

PHASE3TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

December 31, 2008

Conditions
Down SyndromeCognitive Dysfunction
Interventions
DRUG

Aricept (Donepezil hydrochloride)

"All subjects will start with a dose of 1.25 mg/day (1.25 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil.~All doses will be administered orally."

DRUG

Placebo

"All subjects will start with a dose of 1.25 mg/day (1.25 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 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