Phase 2 N=33 Treatment

Mayo Acute Stroke Trial for Enhancing Recovery

Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT00805792 ↗

Enrolled (actual)

Serious AEs

30.3%

Results posted

Nov 2012

Primary outcome: Primary: Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90 — 69; 33; 0; 45 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Donepezil (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90	69; 33; 0; 45	—
SECONDARY Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke	-2.8	<.001 sig
SECONDARY Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke	21.4	<.001 sig
SECONDARY Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke	4.4	<.001 sig
SECONDARY Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke	-43.4; -67.3	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00805792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.