Recruiting
Phase 3

Rehabilitation

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00868010

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

donepezil

placebo

Study Details

Brief summary:

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

Conditions

Ischemic Stroke

Study ID

NCT00868010

Start date

Mar, 2009

Status verified date

Mar, 2013

Completion date

Nov, 2013

Anticipated

Primary completion date

Aug, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1: donepezil

Participants will receive treatment for 12 weeks on donepezil 10 mg (or 5 mg if unable to tolerate 10 mg). Treatment will be then be terminated and participants followed for another 12 weeks naturalistically.

placebo comparator: 2. placebo

Participants will receive treatment for 12 weeks with placebo pill. Treatment will be then be terminated and participants followed for another 12 weeks naturalistically.

Interventions

donepezil

5 mg or 10 mg, titrated per drug insert. Participants may remain in the study at 5 mg if unable to tolerate 10 mg.

placebo

Participants will receive a placebo pill for 12 weeks if randomized to this treatment.

Primary outcome measure

  • Functional Independence Measure (FIM) [ Time Frame: Weekly/12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Ellen M Whyte, MD

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Mar 5, 2013

Last verified

Mar, 2013

Keywords

  • stroke
  • donepezil
  • recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2013-03-05.