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A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties

This study has been completed.
Sponsor:
Information provided by:
Neurognostics
ClinicalTrials.gov Identifier:
NCT00315367
First received: April 14, 2006
Last updated: October 15, 2007
Last verified: October 2007
History of Changes
  Purpose

The purpose of this study is to determine if medication designed to improve memory will help patients with Multiple Sclerosis (MS) who are experiencing memory problems using fMRI to track brain activity.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
 Drug: Donepezil HCI (drug)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Crossover Trial of Aricept® in Memory-Impaired Patients With Multiple Sclerosis: A Phase IV Demonstration of Functional MRI (fMRI) as a Surrogate Marker of Brain Activity Associated With Improvement in Memory Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Neurognostics:

Primary Outcome Measures:
  • Anatomic relationships during cognitive activity, and how these relationships change as a function of drug

Secondary Outcome Measures:
  • fMRI as a surrogate marker for drug efficacy

Estimated Enrollment: 26
Study Start Date: September 2004
Study Completion Date: October 2007
Detailed Description:

Donepezil HCI (Aricept®) is an FDA-approved drug now used to enhance memory in patients with Alzheimer's disease. The aim of this project is to examine the effects of Donepezil HCI (Aricept®) on memory induced brain activation patterns in the context of a double-blind, crossover trial of patients with multiple sclerosis (MS). We will perform task activation experiments involving two cognitive domains. The proposed work on MS patients should yield new information regarding functional anatomic relationships during cognitive activity, and how these relationships change as a function of drug treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 18 and 65 years of age and experiencing some forgetfulness
  • Diagnosed with MS, currently taking Rebif® and experiencing mild memory problems
  • Participants will have stable medication dosages 1 month prior to testing
  • With no past or present neurological disorders (e.g. head trauma, seizures, encephalitis, stroke) except MS
  • With no known medical illnesses (e.g. diabetes, uncontrolled hypertension, arthritis)
  • With no psychiatric illness
  • With no current substance abuse
  • Females should not be pregnant or nursing
  • With no metallic devices in the body or claustrophobia

Exclusion Criteria:

  • Previous history of CNS disturbance other than MS
  • Severe motor or visual impairment that might interfere with the cognitive activation tasks
  • Prescribed psychoactive medications
  • Memory deficits caused by other significant neurological disease or psychiatric disorder
  • Active malignancy within one year of study participation
  • Known human immunodeficiency virus (HIV)
  • Current diagnosis of unstable glaucoma; history of myocardial infarction
  • Symptomatic Coronary Artery Disease within the last 12 months or evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ECG; poorly controlled or labile hypertension
  • History of epilepsy or other seizure disorder within the past 12 months
  • Allergy or hypersensitivity to amphetamines or other sympathomimetic amines
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315367

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Neurognostics
Investigators
Principal Investigator: Safwan Jaradeh, MD Medical College of Wisconsin
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00315367     History of Changes
Other Study ID Numbers: MSA1-904
Study First Received: April 14, 2006
Last Updated: October 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurognostics:
Multiple Sclerosis
Memory impairment

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013