Enhancing Rehabilitation After Stroke
Enhance
Donepezil to Promote Functional Recovery Post-stroke
2 other identifiers
interventional
200
1 country
2
Brief Summary
This is a 12-week, randomized, placebo controlled study to determine if donepezil (Aricept) treatment during rehabilitation after stroke improves functional recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2009
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 22, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMarch 5, 2013
March 1, 2013
4.4 years
March 22, 2009
March 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Independence Measure (FIM)
Weekly/12 weeks
Secondary Outcomes (1)
Cognitive Function (ImPACT battery used to assess attention - working memory continuum, information processing speed, and verbal and visual episodic memory.)
Multiple time points over 12 weeks
Study Arms (2)
1: donepezil
EXPERIMENTALParticipants 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.
2. placebo
PLACEBO COMPARATORParticipants will receive treatment for 12 weeks with placebo pill. Treatment will be then be terminated and participants followed for another 12 weeks naturalistically.
Interventions
Eligibility Criteria
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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hillside Rehabilitation Hospital
Warren, Ohio, 44484, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (2)
Thom T, Haase N, Rosamond W, Howard VJ, Rumsfeld J, Manolio T, Zheng ZJ, Flegal K, O'Donnell C, Kittner S, Lloyd-Jones D, Goff DC Jr, Hong Y, Adams R, Friday G, Furie K, Gorelick P, Kissela B, Marler J, Meigs J, Roger V, Sidney S, Sorlie P, Steinberger J, Wasserthiel-Smoller S, Wilson M, Wolf P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2006 Feb 14;113(6):e85-151. doi: 10.1161/CIRCULATIONAHA.105.171600. Epub 2006 Jan 11. No abstract available.
PMID: 16407573BACKGROUNDWhyte EM, Lenze EJ, Butters M, Skidmore E, Koenig K, Dew MA, Penrod L, Mulsant BH, Pollock BG, Cabacungan L, Reynolds CF 3rd, Munin MC. An open-label pilot study of acetylcholinesterase inhibitors to promote functional recovery in elderly cognitively impaired stroke patients. Cerebrovasc Dis. 2008;26(3):317-21. doi: 10.1159/000149580. Epub 2008 Jul 31.
PMID: 18667813BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen M Whyte, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 22, 2009
First Posted
March 24, 2009
Study Start
March 1, 2009
Primary Completion
August 1, 2013
Study Completion
November 1, 2013
Last Updated
March 5, 2013
Record last verified: 2013-03