Expired Study
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Jacksonville, Florida 32224


Purpose:

This study involves treating patients that have suffered an acute ischemic stroke with the medication donepezil (Aricept ®). The intention is to see if taking donepezil (FDA-approved for the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances recovery.


Study summary:

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. Patients will be men and women with acute (< 24 hours of onset of symptoms) ischemic stroke. We will test this hypothesis in a Phase II trial that takes advantage of an existing National Institutes of Neurological Disorders and Stroke (NINDS) resource, the Phase III clinical trial of tPA for acute ischemic stroke, to establish whether a large efficacy study using donepezil is justified. The NINDS tPA stroke trial has been used as historical control data in pilot trials of reperfusion and neuroprotection. Our proposed trial has significance beyond the specific case of testing donepezil. It will create a novel scientific resource for testing other recovery-enhancing strategies by providing information on acute-to-chronic trajectories of cognition and instrumental activities of daily living (IADL) function following ischemic stroke. Incorporating cognitive measures into the trial is in keeping with the Fifth Stroke Therapy Academic Industry Roundtable (STAIR V). Our study will use a stratified 2-stage Phase II design that, if successful, will help break the cost-innovation barrier by avoiding expensive Phase III trials with little chance of success.


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.


NCT ID:

NCT00805792


Primary Contact:

Principal Investigator
James F. Meschia, M.D.
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Jacksonville, Florida 32224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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