Trial Outcomes & Findings for Donepezil HCl & Cognitive Deficits in Autism (NCT NCT00047697)

NCT ID: NCT00047697

Last Updated: 2017-10-05

Results Overview

TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2017-10-05

Participant Flow

Participant milestones

Measure	Donepezil HCL Subjects placed on 5 and 10 mg of donepezil	Placebo Subjects placed on 5 mg or 10 mg of placebo
Overall Study STARTED	18	16
Overall Study COMPLETED	18	14
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Donepezil HCl & Cognitive Deficits in Autism

Baseline characteristics by cohort

Measure	Donepezil HCL n=18 Participants 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.	Placebo n=16 Participants Participants will start with 5 mg/day of placebo, then have their doses increased to 10 mg/day of placebo after 4 weeks.	Total n=34 Participants Total of all reporting groups
Age, Continuous	11.6 years n=5 Participants	11.8 years n=7 Participants	11.7 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Cognitive Assessment: TMT	123.6 Seconds STANDARD_DEVIATION 56.5 • n=5 Participants	154.9 Seconds STANDARD_DEVIATION 77.8 • n=7 Participants	138.3 Seconds STANDARD_DEVIATION 66.5 • n=5 Participants
Cognitive Assessment: EOWVT Standard score	104.6 units on a scale STANDARD_DEVIATION 22.4 • n=5 Participants	108.7 units on a scale STANDARD_DEVIATION 17.0 • n=7 Participants	106.5 units on a scale STANDARD_DEVIATION 19.9 • n=5 Participants
Cognitive Assessment: CVLT	40.7 Correct answers, percentage STANDARD_DEVIATION 14.1 • n=5 Participants	47.1 Correct answers, percentage STANDARD_DEVIATION 10.3 • n=7 Participants	43.7 Correct answers, percentage STANDARD_DEVIATION 12.3 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

TMT: Trial-Making Test. Time (sec) Range: 0 - 300. Lower = better

Outcome measures

Measure	Donepezil HCl n=18 Participants 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 n=16 Participants Placebo used in placed of Donepezil HCL
Cognitive Assessment: TMT	118.3 seconds Standard Deviation 79.1	104.7 seconds Standard Deviation 53.4

PRIMARY outcome

Timeframe: 8 weeks

Expressive One Word Vocabulary Test (standard score) Range: 55-140. Higher = better

Outcome measures

Measure	Donepezil HCl n=18 Participants 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 n=16 Participants Placebo used in placed of Donepezil HCL
Cognitive Assessment: EOWVT Standard Score	109.7 units on a scale Standard Deviation 21.0	114.5 units on a scale Standard Deviation 16.1

PRIMARY outcome

Timeframe: 8 weeks

California Verbal Learning Test (percent of correct answers) Range: 0-100. Higher = better

Outcome measures

Measure	Donepezil HCl n=18 Participants 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 n=16 Participants Placebo used in placed of Donepezil HCL
Cognitive Assessment: CVLT	50.2 percentage of correct answers Standard Deviation 11.0	51.3 percentage of correct answers Standard Deviation 14.7

Adverse Events

Donepezil HCL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin L. Handen, PhD

University of Pittsburgh

Phone: 412-235-5445

Email: handenbl@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place