Relapsing-Remitting Multiple SclerosisPhase 4NCT00315367
A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties
A Phase 4 study testing Donepezil HCI (drug) in people with Relapsing-Remitting Multiple Sclerosis, run by Neurognostics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Donepezil HCI (drug)
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- With no current substance abuse
- Females should not be pregnant or nursing
- With no metallic devices in the body or claustrophobia
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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
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.
Read the 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.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Donepezil HCI (drug)
- Keywords
- Multiple Sclerosis, Memory impairment
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HCI (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startSep 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurognostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Safwan Jaradeh, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315367
- Sponsor's protocol ID
- MSA1-904
- Status last verified
- Oct 2007
- First submitted
- 14 Apr 2006
- Last updated
- 16 Oct 2007
- Results posted
- No
Publications
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.
PubMed 15534239
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00315367
- Acronym / sponsor ID
- MSA1-904
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Memory impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- NeurognosticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil HCI (drug) | Drug | – |
Primary outcome
Anatomic relationships during cognitive activity, and how these relationships change as a function of drug
1 secondary outcome
fMRI as a surrogate marker for drug efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2007.
- Background: PubMed 15534239Krupp 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.
Related trials for Relapsing-Remitting Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safwan Jaradeh, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil HCI (drug) in people with Relapsing-Remitting Multiple Sclerosis, run by Neurognostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic relationships during cognitive activity, and how these relationships change as a function of drug. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2007.