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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00315367

Enrollment

Registered

2006-04-18

Start date

2004-09-30

Completion date

2007-10-31

Last updated

2007-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis, Memory impairment

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.

Interventions

DRUGDonepezil HCI (drug)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Anatomic relationships during cognitive activity, and how these relationships change as a function of drug	—

Secondary

Measure	Time frame
fMRI as a surrogate marker for drug efficacy	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026