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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Donepezil HCI (drug)
Sponsored by
Neurognostics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Memory impairment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical College of Wisconsin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

fMRI as a surrogate marker for drug efficacy

Full Information

First Posted
April 14, 2006
Last Updated
October 15, 2007
Sponsor
Neurognostics
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1. Study Identification

Unique Protocol Identification Number
NCT00315367
Brief Title
A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurognostics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, Memory impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Donepezil HCI (drug)
Primary Outcome Measure Information:
Title
Anatomic relationships during cognitive activity, and how these relationships change as a function of drug
Secondary Outcome Measure Information:
Title
fMRI as a surrogate marker for drug efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safwan Jaradeh, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15534239
Citation
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.
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A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties

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