Mayo Acute Stroke Trial for Enhancing Recovery (MASTER) protocol

Area of Science:

• Neurology
• Pharmacology
• Clinical Trials

Background:

• Stroke is a leading cause of adult disability, often causing physical, emotional, and cognitive impairments.
• Current pharmacologic treatments for accelerating stroke recovery are limited.
• Donepezil hydrochloride is being explored as a potential pharmacotherapy to enhance stroke recovery.

Purpose of the Study:

• To evaluate the efficacy of donepezil hydrochloride in improving recovery outcomes after acute ischemic stroke.
• To assess the safety and tolerability of donepezil hydrochloride in stroke patients.
• To determine the optimal dosage and treatment duration for donepezil hydrochloride in stroke recovery.

Main Methods:

• A prospective, stratified 2-stage trial (MASTER) involving 30-40 patients with acute ischemic stroke.
• Patients receive up to 10 mg of donepezil daily for 90 days, initiated within 24 hours of symptom onset.
• Comprehensive assessments of neurologic, cognitive, functional, and psychological status are conducted at multiple time points up to 6 months post-treatment.

Main Results:

• The primary outcome is excellent neurologic recovery (NIH Stroke Scale score 0 or 1 at 90 days).
• Secondary outcomes include favorable modified Rankin Scale and Mini-Mental State Examination scores.
• Detailed results on patient outcomes will be reported upon study completion.

Conclusions:

• Donepezil hydrochloride shows promise as a pharmacotherapy for enhancing stroke recovery.
• Further research is needed to confirm the efficacy and long-term benefits of donepezil hydrochloride in stroke patients.
• This trial will provide valuable data on the role of donepezil hydrochloride in post-stroke rehabilitation.