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

NCT00315367 | Completed Phase 4

• 1 other identifier: MSA1-904
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Memory impairment

Outcome Measures

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

Interventions

Donepezil HCI (drug) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurognostics: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 15534239 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Memory Disorders

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Safwan Jaradeh, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 18, 2006
• Study Start: September 1, 2004
• Study Completion: October 1, 2007
• Last Updated: October 16, 2007

Record last verified: 2007-10

Locations

US (1)