Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
CompletedPhase 2Results postedLast updated 19 April 2021
What this trial tests
Phase 2 trial testing Donepezil HCl in Down Syndrome in 129 participants. Completed in 5 September 2008.
Adults 10 to 17, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in V-Scale Composite Score (Sum of 9 Sub-Domains) of Vineland Adaptive Behavior Scales Second Edition-Parent Caregiver Rating Form (VABS-II/PCRF) at Week 10-Last Observation Carried Forward (LOCF)Primary· Baseline, Week 10
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-scores, which are based on age and a national sample of normal children. Each sub-domain v-scale sc
Baseline
Group
Value
95% CI
Donepezil HCl
83.1
± 15.5
Placebo
85.7
± 15.8
Mean change from baseline at Week 10
Group
Value
95% CI
Donepezil HCl
4.74
± 9.2
Placebo
4.22
± 8.5
Mean Change From Baseline in V-Scale Composite Score (Sum of 9 Sub-domains) of Vineland Adaptive Behavior Scales Second Edition-Parent Caregiver Rating Form (VABS-II/PCRF) at Week 4 and 10-Observed Cases (OC)Secondary· Baseline, Week 4 and Week 10
The VABS-II/PCRF instrument was used in this study to assess 3 domains (each with 3 sub-domains): communication (sub-domains: receptive, expressive, 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-scores, which are based on age and a national sample of normal children. Each sub-domain v-scale score
Baseline
Group
Value
95% CI
Donepezil HCl
83.1
± 15.5
Placebo
85.7
± 15.8
Mean change from baseline at Week 4
Group
Value
95% CI
Donepezil HCl
1.5
± 6.4
Placebo
2.6
± 8.5
Mean change from baseline at Week 10
Group
Value
95% CI
Donepezil HCl
5.1
± 9.6
Placebo
4.2
± 8.6
Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER) Total Score at Week 4 and 10-OCSecondary· Baseline, Week 4 and Week 10
The TOVER is a participant-performance-based measure of expressive language function and verbal reasoning in response to questions about a series of stylized pictures showing identifiable scenarios. The 64-item test was specifically designed to assess language function in children and adults with down syndrome (DS) across a broad range of functional ability. The test used 23 multi-colored pictures to stimulate verbal responses to questions. The test was short (completed in 15 minutes) and fast-paced (2 to 4 questions per picture). Total score ranging from 0 to 64, was derived from 64 questions
Baseline
Group
Value
95% CI
Donepezil HCl
20.7
± 12.2
Placebo
21.6
± 11.4
Mean change from baseline at Week 4
Group
Value
95% CI
Donepezil HCl
1.2
± 6.4
Placebo
0.9
± 8.5
Mean change from baseline at Week 10
Group
Value
95% CI
Donepezil HCl
2.6
± 6.2
Placebo
1.9
± 5.5
Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER) Total Score at Week 10-LOCFSecondary· Baseline, Week 10
The TOVER is a participant-performance-based measure of expressive language function and verbal reasoning in response to questions about a series of stylized pictures showing identifiable scenarios. The 64-item test was specifically designed to assess language function in children and adults with DS across a broad range of functional ability. The test used 23 multi-colored pictures to stimulate verbal responses to questions. The test was short (completed in 15 minutes) and fast-paced (2 to 4 questions per picture). Total score ranging from 0 to 64, was derived from 64 questions, where higher s
Baseline
Group
Value
95% CI
Donepezil HCl
20.7
± 12.2
Placebo
21.6
± 11.4
Mean change from baseline at Week 10
Group
Value
95% CI
Donepezil HCl
2.4
± 6.0
Placebo
2.1
± 5.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 10 months.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 19 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00570128.