Mayo Acute Stroke Trial for Enhancing Recovery

NCT00805792 | Completed Phase 2 Results

• 1 other identifier: 08-005098
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic stroke; treatment; recovery; donepezil; Aricept

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke

  baseline, 90 days post-stroke

• Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke

  baseline, 90 days post-stroke

• Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke

  baseline, 90 days post-stroke

• Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke

  baseline, 90 days post-stroke

Study Arms (1)

Donepezil

EXPERIMENTAL

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.

Drug: Donepezil

Interventions

Donepezil DRUG

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.

Also known as: Aricept

Donepezil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (3)

• 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.

  PMID: 20610186 BACKGROUND

• 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.

  PMID: 7477192 BACKGROUND

• 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.

  PMID: 21295494 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: James F. Meschia, MD
• Organization: Mayo Clinic

meschia.james@mayo.edu

904-953-2903

Study Officials

• James F. Meschia, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 30, 2021
• Results First Posted: November 14, 2012

Record last verified: 2021-07

Locations

US (1)