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

NCT ID: NCT00315367

Last Updated: 2007-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-10-31

Brief Summary

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.

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Memory impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Donepezil HCI (drug)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurognostics

INDUSTRY

Sponsor Role: lead

Principal Investigators

Safwan Jaradeh, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Krupp LB, Christodoulou C, Melville P, Scherl WF, MacAllister WS, Elkins LE. Donepezil improved memory in multiple sclerosis in a randomized clinical trial. Neurology. 2004 Nov 9;63(9):1579-85. doi: 10.1212/01.wnl.0000142989.09633.5a.

Reference Type: BACKGROUND

PMID: 15534239 (View on PubMed)

Other Identifiers

MSA1-904

Identifier Type: -

Identifier Source: org_study_id