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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00227994
First received: September 26, 2005
Last updated: March 7, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Pittsburgh:

Primary Outcome Measures:
  • Cognitive and physical function (measured by the Functional Independence Measure and the Apathy Evaluation Scale at Week 12)

Secondary Outcome Measures:
  • Medication tolerability (measured throughout the study)

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: March 2005
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
Genders Eligible for Study:   Both
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
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
Investigators
Principal Investigator: Eric J. Lenze, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00227994     History of Changes
Other Study ID Numbers: K23 MH64196-01, K23MH064196-01, DATR AK-TNGP2
Study First Received: September 26, 2005
Last Updated: March 7, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 21, 2014