Enhancing Rehabilitation After Stroke

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12-week, randomized, placebo controlled study to determine if donepezil (Aricept) treatment during rehabilitation after stroke improves functional recovery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Donepezil

Criteria

Inclusion Criteria:

1. male or female;

2. aged 18 or older;

3. new ischemic stroke within the preceding 30 days; and

4. admitted to the an inpatient facility of the UPMC Institute for Rehabilitation and Research for post-stroke rehabilitation.

Exclusion Criteria:

1. primary hemorrhagic stroke;

2. current use of a cholinomimetic drug including tacrine, donepezil, galantamine, and rivastigmine;

3. contraindication to AchEi therapy including bradycardia (< 50 bpm), severe asthma or COPD requiring nebulized medication, and active upper GI bleed or untreated gastric ulcer;

4. myocardial infarction, poorly controlled congestive heart failure, or coronary bypass surgery within the last 3 months;

5. current required use of an anticholinergic medication (e.g., for bladder spasm);

6. 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);

7. current Major Depressive Episode AND HRSD > 20;

8. current active suicidal ideation, plan, or intent;

9. current mania or hypomania;

10. current psychosis;

11. meeting DMS-IV TR alcohol or substance abuse or dependence criteria within the preceding 3 months;

12. subject and/or family informant do not speak English;

13. history of a progressive or unstable CNS disease (e.g., multiple sclerosis, Parkinson's disease, HIV with CNS involvement);

14. medically unstable (determined by review of the subject's medical status with the treating (clinical) physician and by review of standard blood tests); and

15. history of sensitivity to donepezil;

16. 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.

17. 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.

18. For females of child-bearing age, current breast feeding.

19. suicidal attempt in the past one year,

20. an inpatient admission for depression in the past one year