The main purpose of this study is to assess the ability of a repeated high-frequency site-based computerized cognitive assessment to evaluate the potential treatment effects of donepezil (MK-0000) compared with placebo among participants with mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD). The primary study hypothesis is that the average percentage of correct responses on one card learning (OCL) task will be ≥2 percentage points in participants receiving donepezil compared with participants receiving placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Donepezil 5 mg capsules for a total daily dose of up to 10 mg QD, orally, for Days 1-56.
Dose matched placebo capsule QD, orally for Days 1-56.
Collaborative Neuroscience Network ( Site 0010)
Long Beach, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0013)
Hallandale, Florida, United States
Charter Research - Lady Lake ( Site 0025)
Lady Lake, Florida, United States
iResearch Atlanta ( Site 0005)
Decatur, Georgia, United States
iResearch Savannah ( Site 0023)
Savannah, Georgia, United States
Pennington Biomedical Research Center ( Site 0006)
Baton Rouge, Louisiana, United States
Insight Clinical Trials ( Site 0020)
Beachwood, Ohio, United States
North Texas Clinical Trials - Fort Worth - West Rosedale ( Site 0022)
Fort Worth, Texas, United States
Royal Adelaide Hospital-CALHN Memory Trials ( Site 0031)
Adelaide, South Australia, Australia
Austin Health ( Site 0030)
Heidelberg, Victoria, Australia
Change From Baseline in Averaged Correct Response Rate on the One Card Learning Task to Week 8
One Card Learning (OCL) uses a pattern separation paradigm to assess visual memory. The change from baseline of correct responses on the OCL task up to Week 8 is compared in participants receiving donepezil with participants receiving placebo. Change from baseline was the averaged correct response rate at Week 8 minus the correct response rate at baseline.
Time frame: Baseline, Up to Week 8
Change From Baseline in Standard Deviation for Averaged Correct Response Rate on the OCL Task (Arcsine Square Root Transformed) to Week 8
OCL uses a pattern separation paradigm to assess visual memory. Change in standard deviation from baseline for correct response rate on the OCL task up to Week 8 is compared in participants with mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD) receiving donepezil with participants receiving placebo. Change from baseline was the standard deviation for correct response rate at Week 8 minus the standard deviation for correct response rate at baseline. Standard deviations are reported in arcsine square root (sqrt) transformed correct response (CR) rate.
Time frame: Baseline, Up to Week 8
Change From Baseline in Averaged Correct Response Rate on the OCL Task to Week 8 in Participants Receiving Donepezil
OCL uses a pattern separation paradigm to assess visual memory. The change from baseline of correct responses on the OCL task up to Week 8 in participants receiving donepezil is presented. Change from baseline was the averaged correct response rate at Week 8 minus the correct response rate at baseline. Per protocol, the placebo group was not included in this analysis.
Time frame: Baseline, Up to Week 8
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