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

Neurognostics

Status and phase

Completed

Phase 4

Conditions

Relapsing-Remitting Multiple Sclerosis

Treatments

Drug: Donepezil HCI (drug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00315367

MSA1-904

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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