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Donepezil for Cognitive Dysfunction in Children with Down Syndrome
NCT00754013Phase 3
Key facts
- Status
- Terminated
- Start
- Sep 2008
- Primary completion
- Oct 2008
- Countries
- 1
- Sponsor
- Eisai Co., Ltd.
- Modality
- Small Molecules
- Drugs
- donepezil
- Conditions
- Down syndrome
01
Overview
Phase 3, randomised, double-blind trial in Down syndrome comparing Donepezil with Placebo (2 arms). Primary endpoint: Vineland-II Adaptive Behavior Scales Parent/Caregiver Rating Form Sum of the 9 Sub-domain V-scores at 10 weeks. Started Sep 2008; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Donepezil
Donepezil hydrochloride starting at 1.25 mg/day, escalating to 5 mg/day.
Placebo
Placebo matching Donepezil dosing schedule.
03
Who it enrols
Children aged 6-10 with Down syndrome, generally healthy, with reliable caregivers. Excludes those with recent use of cholinesterase inhibitors or unstable medical conditions.
04
Endpoints
Primary
Vineland-II Adaptive Behavior Scales Parent/Caregiver Rating Form Sum of the 9 Sub-domain V-scores
Secondary
Mean Change From Baseline to Visit 3 in VABS-II/PCRF Sum of the 9 Sub-domain V-scores
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