Mayo Acute Stroke Trial for Enhancing Recovery

Ischemic Stroke Clinical Trial

— MASTER  

Official title:

Mayo Acute Stroke Trial for Enhancing Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805792
• Other study ID #: 08-005098
• Status: Completed
• Phase: Phase 2
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Donepezil
Study participants will be treated with donepezil orally at an initial dose of 5 mg daily for the first 4 weeks, then increased at their 30-day visit by 5 mg to a maximum dose of 10 mg daily, if tolerated. If the participant does not tolerate the 10 mg dose, they will remain on 5 mg through the course of the study.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 s — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90	The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).	90 days post-stroke
Secondary	Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke	The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).	baseline, 90 days post-stroke
Secondary	Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke	The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.	baseline, 90 days post-stroke
Secondary	Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke	The mini-mental state examination (MMSE) is a 30-point questionnaire test that is used to screen for cognitive impairment. The questionnaire samples functions including arithmetic, memory and orientation to time and place. Scores range from 0 to 30. Any score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (=9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.	baseline, 90 days post-stroke
Secondary	Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke	The Trail-making test consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the test: A, in which the targets are all numbers (1,2,3, etc.)and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.).	baseline, 90 days post-stroke

External Links

•   Mayo Clinic Clinical Trials