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OpenTrials
Completed

NCT Number: NCT00315367

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil HCI (drug)

Drug

Primary outcomes

  1. Anatomic relationships during cognitive activity, and how these relationships change as a function of drug

Secondary outcomes

  1. fMRI as a surrogate marker for drug efficacy

Sponsors and collaborators

Lead sponsor

Neurognostics

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2007
First posted
Apr 18, 2006
Registry last updated
Oct 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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