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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Down Syndrome
Cognitive Dysfunction
Interventions Drug: Aricept (Donepezil hydrochloride)
Drug: Placebo
Enrollment 9
Recruitment Details This study planned to recruit subjects at 26 centers in the United States. However, the study was terminated early and only 5 centers enrolled subjects during the period of 06 Oct 2008 to 10 Dec 2008.
Pre-assignment Details  
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil. Donepezil matched placebo was titrated in the similar way as the donepezil arm.
Period Title: Overall Study
Started 4 5
Completed 0 0
Not Completed 4 5
Reason Not Completed
Lost to Follow-up             1             1
didn't return after study termed             3             4
Arm/Group Title Donepezil Placebo Total
Hide Arm/Group Description Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil. Donepezil matched placebo was titrated in the similar way as the donepezil arm. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
9.0  (0.8) 8.0  (1.4) 8.5  (0.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
2
  50.0%
3
  60.0%
5
  55.6%
Male
2
  50.0%
2
  40.0%
4
  44.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White (n) Number Analyzed 4 participants 5 participants 9 participants
4 5 9
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Visit 0 (Screen), Visits 1 (Baseline), 2, and 3 (or Early Termination).
Hide Outcome Measure Data
Hide Analysis Population Description
The planned efficacy analysis was on the intent-to-treat (ITT) population. This study was terminated early. Primary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
Donepezil matched placebo was titrated in the similar way as the donepezil arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Visit 1 (Baseline) to Visit 3 (Week 10 or early termination).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early. Secondary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
Donepezil matched placebo was titrated in the similar way as the donepezil arm.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil. Donepezil matched placebo was titrated in the similar way as the donepezil arm.
All-Cause Mortality
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   3/5 (60.00%) 
Gastrointestinal disorders     
Bruxism  0/4 (0.00%)  1/5 (20.00%) 
Tongue disorder  0/4 (0.00%)  1/5 (20.00%) 
Infections and infestations     
Upper respiratory infection  0/4 (0.00%)  1/5 (20.00%) 
Nervous system disorders     
Headache  1/4 (25.00%)  1/5 (20.00%) 
Psychiatric disorders     
Abnormal behavior  0/4 (0.00%)  1/5 (20.00%) 
Due to the study terminating early,only 9 subjects were enrolled and these subjects receive only limited exposure to study medications with no subject reaching his/her maximum targeted dose. Therefore,the planned efficacy criteria were not analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eisai Medical Services
Organization: Eisai inc.
Phone: 1-888-422-4743
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00754013     History of Changes
Other Study ID Numbers: E2020-A001-336
A2501061
First Submitted: September 15, 2008
First Posted: September 17, 2008
Results First Submitted: July 21, 2011
Results First Posted: February 13, 2013
Last Update Posted: March 21, 2017