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Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227994
First Posted: September 28, 2005
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Lenze, University of Pittsburgh
September 26, 2005
September 28, 2005
May 2, 2016
December 28, 2016
December 11, 2017
April 2003
January 2005   (Final data collection date for primary outcome measure)
Physical Function (Measured by the FIM-motor) [ Time Frame: Measured at weeks 0 and 12 ]
Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence
Cognitive function
Complete list of historical versions of study NCT00227994 on ClinicalTrials.gov Archive Site
Medication Tolerability [ Time Frame: Measured throughout the study ]
Number of participants who withdrew due to side effects.
Functional recovery
Not Provided
Not Provided
 
Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke
Donepezil/ Galantamine in the Treatment of Post-stroke Cognitively Impaired Rehabilitating Elderly
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Cognitive impairment is a common result of a stroke and can be detrimental to recovery. It can negatively affect both mental and physical functioning, thereby complicating the rehabilitation process. Although much research has targeted the effects of long-term cognitive impairment after a stroke, very little research has been done to examine the incidence and course of cognitive impairment during the first three months following a stroke. These first three months are the most important in terms of regaining function. Acetylcholinesterase inhibitors have been beneficial to both sufferers of vascular dementia and Alzheimer's disease. They may also be a useful pharmacologic intervention to enhance post-stroke rehabilitation. This study will compare the effectiveness of two acetylcholinesterase inhibitors, galantamine and donepezil, in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Participants in this open label study will be randomly assigned to receive either galantamine or donepezil for 12 weeks. Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study. Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks. Functional independence will be measured at baseline and Weeks 2 and 12. In addition, a pre-stroke level of functional independence will be obtained through a structured interview with participants and their families. Participants will also be monitored for signs of depression and medication side effects throughout the study.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cerebrovascular Accident
  • Drug: Galantamine
    Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.
    Other Name: Razadyne
  • Drug: Donepezil
    Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
    Other Name: Aricept
  • Experimental: Galantamine
    Galantamine for 12 weeks
    Intervention: Drug: Galantamine
  • Experimental: Donepezil
    Donepezil for 12 weeks
    Intervention: Drug: Donepezil
Whyte 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2005
January 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Admitted to a rehabilitation hospital with primary diagnosis of ischemic stroke (cardiovascular accident)
  • Stroke was within 30 days of being admitted
  • Medically stable
  • Presence of memory and/or attentional impairments and evidence that these impairments were not present or were less severe prior to the stroke (assessed via interview with family)
  • Approval by individual's attending physician at the rehabilitation hospital

Exclusion Criteria:

  • Aphasia or cognitive (or behavioral) impairments severe enough to prevent valid neuropsychiatric assessment
  • Currently experiencing a major depressive episode (unless treated and in partial remission, assessed using the Primary Care Evaluation of Mental Disorders)
  • Current psychosis or mania
  • History of substance or alcohol abuse or dependence within three months of study entry
  • Currently taking a cholinomimetic drug
  • Medical condition with known sensitivity to donepezil (e.g., slower than normal heart rate, supraventricular cardiac conduction defects, severe asthma or obstructive pulmonary disease, active upper gastrointestinal bleed, or gastric/duodenal ulcer if not on acid-blocking agent)
  • Informed that taking donepezil is medically inadvisable
  • Current use of any anticholinergic medication (e.g., for bladder spasm)
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00227994
K23MH064196-01( U.S. NIH Grant/Contract )
K23MH064196-01 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: study has small sample size and is unlikely to be useful for data sharing efforts; however, interested researchers can contact the first author via email.
Eric Lenze, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Eric J. Lenze, MD University of Pittsburgh
University of Pittsburgh
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP