Enhancing Rehabilitation After Stroke
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Ischemic Stroke
In brief
This is a 12-week, randomized, placebo controlled study to determine if donepezil (Aricept) treatment during rehabilitation after stroke improves functional recovery.
Key facts
- Study ID
- NCT00868010
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 200
- Starts
- 2009-03-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2013-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
- Hillside Rehabilitation Hospital — Warren, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.