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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Lenze, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00227994
First received: September 26, 2005
Last updated: October 30, 2016
Last verified: October 2016
  Purpose
This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Condition Intervention Phase
Cerebrovascular Accident Drug: Galantamine Drug: Donepezil Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Donepezil/ Galantamine in the Treatment of Post-stroke Cognitively Impaired Rehabilitating Elderly

Resource links provided by NLM:


Further study details as provided by Eric Lenze, University of Pittsburgh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Medication Tolerability [ Time Frame: Measured throughout the study ]
    Withdrawal due to side effects


Enrollment: 40
Study Start Date: April 2003
Study Completion Date: March 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Galantamine
Galantamine for 12 weeks
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
Experimental: Donepezil
Donepezil for 12 weeks
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227994

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Eric J. Lenze, MD University of Pittsburgh
  More Information

Publications:
Responsible Party: Eric Lenze, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00227994     History of Changes
Other Study ID Numbers: K23MH064196-01 ( U.S. NIH Grant/Contract )
Study First Received: September 26, 2005
Results First Received: May 2, 2016
Last Updated: October 30, 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Eric Lenze, University of Pittsburgh:
Cholinesterase Inhibitors
Elderly
Stroke
Cognition

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Donepezil
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 21, 2017