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Visual Attention Measures for Early Donepezil Response in AD
NCT03073876Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2005
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- NYU Langone Health
- Modality
- Small Molecules
- Drugs
- donepezil
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 4, randomised, double-blind trial in Alzheimer's disease (AD) comparing Donepezil Arm with Placebo/Delayed Start Arm (2 arms). Primary endpoints: Change in Foreperiod Effect Task - Processing Speed at 6 weeks, Change in Covert Orienting Task at 6 weeks and 8 more. Started Dec 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Donepezil Arm
Donepezil 5mg daily from baseline.
Placebo/Delayed Start Arm
Placebo for 6 weeks, then Donepezil 5mg daily.
03
Endpoints
Primary
Change in Foreperiod Effect Task - Processing Speed
Change in Covert Orienting Task
Change in Attentional Blink Task - SOA 266ms
Change in Attentional Blink Task - SOA 399ms
Alzheimer's Disease Assessment Scale - Cognitive
Secondary
Dementia Rating Scale
Mini Mental Status Examination
Alzheimer's Disease Assessment Scale - Cognitive
Change in Digit Span Forward
Change in Hopkins Verbal Learning Test- Revised - Recall
Change in Language Function Assessed With the Letter Fluency Test
Change on Trail Making Test - Condition
Change in Visual Form Discrimination
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