Clinical trial NCT00805792: Mayo Acute Stroke Trial for Enhancing Recovery
Official title: Mayo Acute Stroke Trial for Enhancing Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
treatment
recovery
donepezil
Aricept
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Alzheimer's Disease) for the first 90 days following a stroke enhances recovery.

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 rehabilitation. The null hypothesis is that the probability of a favorable outcome among post-stroke donepezil users is equal to that observed among similar participants in an existing National Institutes of Neurological Disorders and Stroke (NINDS) resource, the Phase III clinical trial of Tissue Plasminogen Activator (tPA) for acute ischemic stroke. The NINDS tPA stroke trial has been used as historical control data in pilot trials of reperfusion and neuroprotection.

The MASTER trial will be a multicenter, single-arm NINDS Recominant tPA trial-controlled, modified 2-stage adaptive clinical trial set in 2 tertiary care hospitals in the United States. Participants will be men and women with acute (\< 24 hours of onset of symptoms) ischemic stroke. A favorable outcome will be defined as National Institutes of Health Stroke Scale (NIHSS) values of 0 or 1 at 90 days post-stroke.

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.

Primary outcomes:
measure: Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
timeFrame: 90 days post-stroke
Secondary outcomes:
measure: Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke
timeFrame: baseline, 90 days post-stroke
measure: Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke
timeFrame: baseline, 90 days post-stroke
measure: Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke
timeFrame: baseline, 90 days post-stroke
measure: Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke
timeFrame: baseline, 90 days post-stroke
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: James F. Meschia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meschia JF, McNeil RB, Barrett KM, Brott TG, Graff-Radford NR, Brown RD Jr. Mayo Acute Stroke Trial for Enhancing Recovery (MASTER) protocol. J Stroke Cerebrovasc Dis. 2010 Jul-Aug;19(4):299-310. doi: 10.1016/j.jstrokecerebrovasdis.2009.05.005.
citation: National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
citation: Barrett KM, Brott TG, Brown RD Jr, Carter RE, Geske JR, Graff-Radford NR, McNeil RB, Meschia JF; Mayo Acute Stroke Trial for Enhancing Recovery (MASTER) Study Group. Enhancing recovery after acute ischemic stroke with donepezil as an adjuvant therapy to standard medical care: results of a phase IIA clinical trial. J Stroke Cerebrovasc Dis. 2011 May-Jun;20(3):177-82. doi: 10.1016/j.jstrokecerebrovasdis.2010.12.009. Epub 2011 Feb 3.