Status:
COMPLETED
Mayo Acute Stroke Trial for Enhancing Recovery
Lead Sponsor:
Mayo Clinic
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
We hypothesize that donepezil (5 mg per day, titrated up to 10 mg per day as tolerated) will enhance recovery following stroke by improving attention, learning and memory thereby enhancing rehabilitat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00805792
Start Date
November 1 2008
End Date
September 1 2010
Last Update
July 30 2021
Active Locations (1)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224