Arciniegas 2020

Current Status of Trial
Completed
Study Aim
Other
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Donepezil // Placebo
Dosage and Duration
Donepezil 10 mg daily
Absolute Number of Participants
75
Health Status/Diagnosis
Traumatic Brain Injury (TBI)
Primary outcomes
Verbal memory problems // Memory-related limitations in everyday function // Other cognitive, neuropsychiatric, functional, and caregiver problems in the chronic period following complicated mild, moderate, or severe TBI
Key Points
"seventy-five participants were randomized to treatment (donepezil N537, placebo N538). Both the mITT and per protocol analyses demonstrated donepezil efficacy on the primary outcome (HVLT-R Total Trials 1-3) (p50.034, d50.44, and p50.036, d50.45, respectively). Donepezil and placebo response rates were 42% and 18%, respectively (p50.027, NNT53.5). Among donepezil responders, delayed recall and processing speed also improved significantly. Treatment-emergent adverse event rates to donepezil and placebo were 46% and 8%, respectively. The majority (85%) of treatment-emergent adverse events to donepezil were mild or moderate; only diarrhea and nausea were significantly more common in the donepezil group." Arciniegas 2020