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

NCT00227994 | Completed Phase 4 Results

• 1 other identifier: K23MH064196-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors in improving cognitive function and overall rehabilitation in elderly stroke survivors.

Conditions

Cerebrovascular Accident

Keywords

Cholinesterase Inhibitors; Elderly; Stroke; Cognition

Outcome Measures

Primary Outcomes (1)

• Physical Function (Measured by the FIM-motor)

  Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence

  Measured at weeks 0 and 12

Secondary Outcomes (1)

• Medication Tolerability

  Measured throughout the study

Study Arms (2)

Galantamine

EXPERIMENTAL

Galantamine for 12 weeks

Drug: Galantamine

Donepezil

EXPERIMENTAL

Donepezil for 12 weeks

Drug: Donepezil

Interventions

Galantamine DRUG

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.

Also known as: Razadyne

Galantamine

Donepezil DRUG

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.

Also known as: Aricept

Donepezil

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• 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.

  PMID: 18667813 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Galantamine; Donepezil

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Polycyclic Compounds

Results Point of Contact

• Title: Eric Lenze
• Organization: Washington University School of Medicine

lenzee@wustl.edu

314-362-1671

Study Officials

• Eric J. Lenze, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: April 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: March 1, 2005
• Last Updated: December 11, 2017
• Results First Posted: December 28, 2016

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)