Status:
UNKNOWN
Enhancing Rehabilitation After Stroke
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 12-week, randomized, placebo controlled study to determine if donepezil (Aricept) treatment during rehabilitation after stroke improves functional recovery.
Detailed Description
Stroke is a leading cause of disability in the US (Thom 2006). The total number of stroke survivors (currently estimated as 5.5 million Americans) will continue to increase as the population ages and ...
Eligibility Criteria
Inclusion
- male or female;
- aged 18 or older;
- new ischemic stroke within the preceding 30 days; and
- admitted to the an inpatient facility of the UPMC Institute for Rehabilitation and Research for post-stroke rehabilitation.
Exclusion
- primary hemorrhagic stroke;
- current use of a cholinomimetic drug including tacrine, donepezil, galantamine, and rivastigmine;
- contraindication to AchEi therapy including bradycardia (\< 50 bpm), severe asthma or COPD requiring nebulized medication, and active upper GI bleed or untreated gastric ulcer;
- myocardial infarction, poorly controlled congestive heart failure, or coronary bypass surgery within the last 3 months;
- current required use of an anticholinergic medication (e.g., for bladder spasm);
- current aphasia severe enough to prevent valid neuropsychiatric assessment (e.g., a score \< 9 on the Token Test, part I and a score of \< 14 (or \<80% accuracy) on the repetition task of the Boston Diagnostic Aphasia Examination);
- current Major Depressive Episode AND HRSD \> 20;
- current active suicidal ideation, plan, or intent;
- current mania or hypomania;
- current psychosis;
- meeting DMS-IV TR alcohol or substance abuse or dependence criteria within the preceding 3 months;
- subject and/or family informant do not speak English;
- history of a progressive or unstable CNS disease (e.g., multiple sclerosis, Parkinson's disease, HIV with CNS involvement);
- medically unstable (determined by review of the subject's medical status with the treating (clinical) physician and by review of standard blood tests); and
- history of sensitivity to donepezil;
- for potential subjects without a pacemaker or implantable defibrillator, exclusion criteria will include (a) ECG evidence of second or third degree heart block ( b ) ECG evidence of a tri-fascicular block (LBBB and 1st degree AV Block; RBBB, left anterior or left posterior hemiblock, and 1st degree AV block) or ( c ) history of syncope within 1 year with a RBBB or a LBBB.
- For females of child-bearing age, current pregnancy, plan to become pregnant while on study drug, or refusal to avoid pregnancy while on study drug.
- For females of child-bearing age, current breast feeding.
- suicidal attempt in the past one year,
- an inpatient admission for depression in the past one year
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00868010
Start Date
March 1 2009
End Date
November 1 2013
Last Update
March 5 2013
Active Locations (2)
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1
Hillside Rehabilitation Hospital
Warren, Ohio, United States, 44484
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213