- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315367
A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties
October 15, 2007 updated by: Neurognostics
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Anatomic relationships during cognitive activity, and how these relationships change as a function of drug
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Secondary Outcome Measures
Outcome Measure |
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fMRI as a surrogate marker for drug efficacy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Safwan Jaradeh, MD, Medical College of Wisconsin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion (ACTUAL)
October 1, 2007
Study Registration Dates
First Submitted
April 14, 2006
First Submitted That Met QC Criteria
April 14, 2006
First Posted (ESTIMATE)
April 18, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
October 16, 2007
Last Update Submitted That Met QC Criteria
October 15, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- MSA1-904
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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