search
Back to results

Mayo Acute Stroke Trial for Enhancing Recovery (MASTER)

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Donepezil
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, treatment, recovery, donepezil, Aricept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Donepezil

Arm Description

Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.).

Full Information

First Posted
December 9, 2008
Last Updated
July 28, 2021
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT00805792
Brief Title
Mayo Acute Stroke Trial for Enhancing Recovery
Acronym
MASTER
Official Title
Mayo Acute Stroke Trial for Enhancing Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic stroke, treatment, recovery, donepezil, Aricept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donepezil
Arm Type
Experimental
Arm Description
Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aricept
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90
Description
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).
Time Frame
90 days post-stroke
Secondary Outcome Measure Information:
Title
Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke
Description
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).
Time Frame
baseline, 90 days post-stroke
Title
Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke
Description
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.
Time Frame
baseline, 90 days post-stroke
Title
Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke
Description
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.
Time Frame
baseline, 90 days post-stroke
Title
Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke
Description
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.).
Time Frame
baseline, 90 days post-stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F. Meschia, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20610186
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.
Results Reference
background
PubMed Identifier
7477192
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.
Results Reference
background
PubMed Identifier
21295494
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.
Results Reference
result
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Mayo Acute Stroke Trial for Enhancing Recovery

We'll reach out to this number within 24 hrs