Mayo Acute Stroke Trial for Enhancing Recovery

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study involves treating patients that have suffered an acute ischemic stroke with the medication donepezil (Aricept ®). The hypothesis is that taking donepezil (FDA-approved for the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances recovery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Definite or probable acute ischemic cerebrovascular syndrome (AICS), as defined by Kidwell et al (Stroke. 2003;34:2995-8).

• Experimental treatment started within 24 hours of onset of symptoms.

• Age ≥ 18 years.

• Ability and willingness to return for follow-up visits.

• Willingness of an available informant who knows the patient well to participate in informant-based questionnaires for the duration of the follow-up period.

• Living in independent or semi-independent living situation before the stroke.

• Fluent in English before the stroke.

• Provides written informed consent.

• Near visual acuity of at least 20/200 in at least one eye.

• Auditory acuity of at least having the ability to detect finger rubbing in at least one ear.

Exclusion Criteria:

• Parkinson's disease or restless leg syndrome.

• Partial or generalized seizures.

• No acute decompensated heart failure

• Routinely requiring daytime supplemental oxygen before the stroke; study participants on continuous positive air pressure (CPAP) for obstructive sleep apnea remain eligible.

• Gastrointestinal or genitourinary surgery within 1 month of screening.

• Gastrointestinal bleeding.

• Syncope or symptomatic bradycardia.

• Creatinine ≥ 3.5 mg/dL or requiring dialysis.

• Peptic ulcer disease.

• Asthma.

• Tracheostomy or endotracheal intubation.

• Taking donepezil or other acetylcholinesterase inhibitor at screening.