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NCT00570128 · ClinicalTrials.gov registry record · Phase 2
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT00570128: Completed Phase 2 study, sponsored by Eisai.
NCT00570128 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00570128, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study 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.
Primary Outcome
The VABS-II/PCRF instrument was used in this study to assess 3 domains (each with 3 sub-domains): communication (sub-domains: receptive, expressive, and writing), daily living skills (sub-domains: personal, domestic, community), and socialization (sub-domains: interpersonal relationships, play/leisure time, coping skills). Raw scores (2=always present, 1=sometimes present, 0=seldom or never present) rated by the parent/caregiver from each sub-domain were converted to standardized scores called V
Interventions
- DRUG Placebo
- DRUG Donepezil HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2007-11-16 |
| Est. Completion | 2008-09-05 |
| Phase | Phase 2 |
What the finished NCT00570128 record still lists
NCT00570128 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00570128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00570128 about?
NCT00570128 is a clinical study titled "Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome". 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 ...
What is the current status of trial NCT00570128?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2007-11-16. Estimated completion is 2008-09-05.
What interventions are being tested in trial NCT00570128?
The interventions under investigation include: Placebo (DRUG), Donepezil HCl (DRUG).
Who is sponsoring clinical trial NCT00570128?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00570128's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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