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Trial record 80 of 331 for:    DONEPEZIL

Donepezil HCl & Cognitive Deficits in Autism

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ClinicalTrials.gov Identifier: NCT00047697
Recruitment Status : Completed
First Posted : October 16, 2002
Results First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autistic Disorder
Interventions Drug: Donepezil HCl
Drug: Placebo
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil HCL Placebo
Hide Arm/Group Description Subjects placed on 5 and 10 mg of donepezil Subjects placed on 5 mg or 10 mg of placebo
Period Title: Overall Study
Started 18 16
Completed 18 14
Not Completed 0 2
Arm/Group Title Donepezil HCL Placebo Total
Hide Arm/Group Description Donepezil HCl: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks. Participants will start with 5 mg/day of placebo, then have their doses increased to 10 mg/day of placebo after 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
11.6
(8.7 to 16.8)
11.8
(8.1 to 16.6)
11.7
(8.1 to 16.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
1
   5.6%
2
  12.5%
3
   8.8%
Male
17
  94.4%
14
  87.5%
31
  91.2%
Cognitive Assessment: TMT   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 18 participants 16 participants 34 participants
123.6  (56.5) 154.9  (77.8) 138.3  (66.5)
[1]
Measure Description: TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
Cognitive Assessment: EOWVT Standard score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 16 participants 34 participants
104.6  (22.4) 108.7  (17.0) 106.5  (19.9)
[1]
Measure Description: Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
Cognitive Assessment: CVLT   [1] 
Mean (Standard Deviation)
Unit of measure:  Correct answers, percentage
Number Analyzed 18 participants 16 participants 34 participants
40.7  (14.1) 47.1  (10.3) 43.7  (12.3)
[1]
Measure Description: California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better
1.Primary Outcome
Title Cognitive Assessment: TMT
Hide Description TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil HCl Placebo
Hide Arm/Group Description:
Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
Placebo used in placed of Donepezil HCL
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: seconds
118.3  (79.1) 104.7  (53.4)
2.Primary Outcome
Title Cognitive Assessment: EOWVT Standard Score
Hide Description Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil HCl Placebo
Hide Arm/Group Description:
Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
Placebo used in place of Donepezil HCL
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
109.7  (21.0) 114.5  (16.1)
3.Primary Outcome
Title Cognitive Assessment: CVLT
Hide Description California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil HCl Placebo
Hide Arm/Group Description:
Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.
Placebo used in place of Donepezil HCL
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: percentage of correct answers
50.2  (11.0) 51.3  (14.7)
Time Frame AEs were collected for 10 weeks (and for longer if a subject had an active AE at the end of the 10-week trial).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil HCL Placebo
Hide Arm/Group Description 5 mg of donepezil for 4 weeks, followed by 10 mg of donepezil for 6 weeks. Placebo substituted for Donepezil HCL
All-Cause Mortality
Donepezil HCL Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil HCL Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Donepezil HCL Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
The trial may not have been long enough to obtain clinically significant effects
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: Benjamin L. Handen, PhD
Organization: University of Pittsburgh
Phone: 412-235-5445
EMail: handenbl@upmc.edu
Layout table for additonal information
Responsible Party: Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00047697     History of Changes
Other Study ID Numbers: R21MH064941 ( U.S. NIH Grant/Contract )
R21MH064941 ( U.S. NIH Grant/Contract )
DSIR CT-M3 ( Other Identifier: NIMH )
First Submitted: October 11, 2002
First Posted: October 16, 2002
Results First Submitted: March 30, 2015
Results First Posted: October 5, 2017
Last Update Posted: October 5, 2017