A Phase 2 interventional study of Donepezil hydrochloride (Aricept) in Down Syndrome, sponsored by Eisai Inc.. Terminated at 31 sites in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by Eisai Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.
All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 117 is above the median of 36 across 283 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant's weight schedule and the Investigator's judgment of safety and tolerability. Re-titration was done to maintain the blinding of the double-blind study (E2020-A001-219). Doses could be decreased due to tolerability and could be increased or decreased to maintain a maximum dose of 0.1 to 0.2 mg/kg/day based on the participant's weight at clinic visits during the study duration.
Drug: Donepezil hydrochloride (Aricept)
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Also known as: Aricept
Change From Visit 1 (Baseline) to Visit 4 or Early Termination in the Vineland Adaptive Behavior Scales, 2nd Edition, Parent/Caregiver Rating Form (VABS-II/PCRF) Sum of the 9 Sub-domain V-scores
VABS-II/PCRF assessed participant's adaptive behaviors on 3 domains (each has 3 sub-domains): Communication (receptive, expressive, written), Daily Living Skills (personal, domestic, community), Socialization (interpersonal relationships, play a leisure time, coping skills). Parent/caregiver rated participant's behavior for sub-domains from 0 (never present) to 2 (always present). Raw scores from sub-domains converted into standardized score(V-scale scores) ranged:1-24 for each sub-domain, mean=15,standard deviation(SD)=3,higher scores=higher level of adaptive functioning and were summed to obtain V-scale composite score ranged 9-216, mean=100,SD=15,higher scores=higher level of adaptive functioning, positive change=improvement in adaptive functioning. Composite and individual analyses, both raw and standardized scores, were not performed due to lack of significant differences between donepezil and placebo in parent study.
Time frame: Visit 1 (baseline); Early Termination Visit (Week 36)
This study was recruited at 24 centers in the United States during the period of 4 Apr 2008 to 15 Dec 2008. All participants who completed the double-blind (DB) placebo-controlled, 10 week study (Study 2020-A001-219 \[NCT00570128\]) were offered enrollment in this study.
| Milestone | Prior Donepezil-DB | Prior Placebo-DB |
|---|---|---|
| Started | 54 | 63 |
| Completed | 0 | 0 |
| Not completed | 54 | 63 |
| Withdrew: Study terminated by sponsor | 38 | 42 |
| Withdrew: Adverse event | 6 | 11 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Withdrawal by subject | 4 | 6 |
VABS-II/PCRF assessed participant's adaptive behaviors on 3 domains (each has 3 sub-domains): Communication (receptive, expressive, written), Daily Living Skills (personal, domestic, community), Socialization (interpersonal relationships, play a leisure time, coping skills). Parent/caregiver rated participant's behavior for sub-domains from 0 (never present) to 2 (always present). Raw scores from sub-domains converted into standardized score(V-scale scores) ranged:1-24 for each sub-domain, mean=15,standard deviation(SD)=3,higher scores=higher level of adaptive functioning and were summed to obtain V-scale composite score ranged 9-216, mean=100,SD=15,higher scores=higher level of adaptive functioning, positive change=improvement in adaptive functioning. Composite and individual analyses, both raw and standardized scores, were not performed due to lack of significant differences between donepezil and placebo in parent study.
| units on a scale | Prior Donepezil-DB | Prior Placebo-DB |
|---|---|---|
| Baseline (Week 10 of DB study) | 87.73 ± 16.58 | 92.02 ± 17.51 |
| Early termination visit | 89.37 ± 20.9 | 91.25 ± 18.45 |
Collected over Baseline up to early termination visit (Week 36). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prior Donepezil-DB | 0/54 (0%) | 0/54 (0%) | 37/54 (68.5%) |
| Prior Placebo-DB | 0/63 (0%) | 0/63 (0%) | 48/63 (76.2%) |
| Event | Prior Donepezil-DB | Prior Placebo-DB |
|---|---|---|
| DiarrheaGastrointestinal disorders | 8/54 | 15/63 |
| SinusitisInfections and infestations | 6/54 | 8/63 |
| Upper respiratory tract infectionInfections and infestations | 2/54 | 7/63 |
| Abdominal pain, upperGastrointestinal disorders | 5/54 | 4/63 |
| VomitingGastrointestinal disorders | 4/54 | 4/63 |
| SomnolenceNervous system disorders | 4/54 | 1/63 |
| NauseaGastrointestinal disorders | 2/54 | 4/63 |
| HeadacheNervous system disorders | 1/54 | 4/63 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/54 | 4/63 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/54 | 4/63 |
| Age, Continuous(years) | Prior Donepezil-DB | Prior Placebo-DB | Total |
|---|---|---|---|
| Mean | 13.4 ± 2.4 | 13.2 ± 2.2 | 13.2 ± 3.3 |
| Sex: Female, Male(Participants) | Prior Donepezil-DB | Prior Placebo-DB | Total |
|---|---|---|---|
| Female | 23 | 34 | 57 |
| Male | 31 | 29 | 60 |
| Race (NIH/OMB)(Participants) | Prior Donepezil-DB | Prior Placebo-DB | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 4 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 46 | 55 | 101 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 1 | 7 |
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Eisai Inc.