Montero-Odasso 2019 / NCT00934531

Study ID(s) and Acronym(s)
NCT00934531
Current Status of Trial
Completed
Study Aim
Treatment MCI
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Donepezil // Placebo
Dosage and Duration
Experimental Arm: Participants with MCI will receive 5 mg/day of donepezil p.o. for 4 weeks, and thereafter 10 mg/day of donepezil p.o. for a period of 5 months, yielding a total period of intervention of 6 months from baseline // Placebo Arm: Participants with MCI will receive a matched placebo p.o. for 4 weeks, and thereafter will receive a new matched placebo p.o. for the next 5 months, yielding a total period of intervention of 6 months from baseline.
Absolute Number of Participants
60
Health Status/Diagnosis
Mild Cognitive Impairment (MCI)
Primary outcomes
Improvements in gait performance
Other outcomes
Balance confidence // Balance sway // Attention // Executive function // Reduction of number of Falls
Key Points
"after 6 months, the donepezil group experienced an improvement in dual-task gait speed (range 4–11 cm/s), although this was not statistically significant. The donepezil group showed a significant reduction in DTC (improvement) by counting backwards by 1 and 7 compared with placebo (10.25% vs. 1.75%, P = 0.048; 21.38% vs. 14.64%, P = 0.037, intention-to-treat analysis). Per-protocol analyses showed that all three DTCs improved in the donepezil group, along with a non-significant reduction of rate of falls. Conclusions: donepezil treatment improved dual-task gait speed and DTC in elderly patients with MCI. Our results support the concept of reducing falls in MCI by targeting the motor–cognitive interface" Montero-Odasso 2019