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
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|ClinicalTrials.gov Identifier: NCT00754013|
Recruitment Status : Terminated (Sufficient evidence of efficacy not met.)
First Posted : September 17, 2008
Results First Posted : February 13, 2013
Last Update Posted : March 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Down Syndrome Cognitive Dysfunction||Drug: Aricept (Donepezil hydrochloride) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate 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|
|Study Start Date :||September 2008|
|Primary Completion Date :||October 2008|
|Study Completion Date :||December 2008|
|Active Comparator: Donepezil||
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.
Other Name: Donepezil hydrochloride
|Placebo Comparator: 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.
- Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward. [ Time Frame: Visit 0 (Screen), Visits 1 (Baseline), 2, and 3 (or Early Termination). ]The primary objective of the study was evaluation of the efficacy and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down syndrome (DS), aged 6 to 10, as assessed by analysis of VABS-II/PCRF in the domains of communication, daily living skills, and socialization, and as assessed by standard safety measurements.
- Mean Change From(Baseline) to Visit 3(Week 10 or Early Termination) in VABS-II/PCRF Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward. [ Time Frame: Visit 1 (Baseline) to Visit 3 (Week 10 or early termination). ]The planned secondary objectives of the study included further evaluation of efficacy as assessed by additional analyses of the VABS-II/PCRF, by analyses of the Test of Verbal Expression and Reasoning (TOVER), a subject-performance-based measure of expressive language function, and by the Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent. In addition, observed case analyses of these assessments at Week 4 and Week 10 were planned.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754013
|United States, Texas|
|Road Runner Research|
|San Antonio, Texas, United States, 78258|
|United States, Virginia|
|Herndon, Virginia, United States, 20170|
|Study Director:||Thomas McRae, MD||Pfizer|