Neurodegenerative DiseasesNCT00249080
Magnetic Resonance Imaging (MRI) of Brain Iron in Neurodegenerative Disease
An observational study of Neurodegenerative Diseases and Mild Cognitive Impairment, run by Albany Medical College.
Trial summary
Neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis are recognized as a major health concern at the present time. There is information in magnetic resonance imaging (MRI) studies regarding the role of brain iron in normal brain aging that may be enhanced with the use of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Mild Cognitive Impairment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Aug 2007
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately equal numbers of subjects with clinically diagnosed Alzheimer's disease, multiple sclerosis, Parkinson's disease and normal controls (age and gender matched).
Who may be able to join
- 18 years or older
- Healthy person without memory complaints OR person diagnosed with a neurodegenerative disease (ie, Alzheimer's disease, Parkinson's disease, multiple sclerosis)
Who cannot join
- MR contraindication such as metal in body (ie, pacemaker, implant, shrapnel, etc.)
- Pregnant
- Claustrophobic anxieties
About this study
Official title: High Field MRI of Brain Iron in Neurodegenerative Disease
Neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis are recognized as a major health concern at the present time. There is information in magnetic resonance imaging (MRI) studies regarding the role of brain iron in normal brain aging that may be enhanced with the use of better scanning equipment and procedures, and by correlating this information with clinical data. This research study aims to develop and evaluate a number of techniques that can potentially improve the effectiveness of three tesla (3T) magnetic resonance imaging of neurodegenerative brain disorders.
Read the detailed description
Eligibility: A healthy person without memory complaints or someone with neurodegenerative disease. However, the person should not have metal in the body (ie, pacemaker, implants, shrapnel, etc.), should not be pregnant, and should not have claustrophobic anxieties.
Study Procedures: During a regular office visit, a neurologist will perform a routine physical and neurological examination, including your medical and family history, to determine your eligibility for this study. You will then be scheduled for a series of neuropsychological tests, which take between 1 to 1.5 hours, and an MRI scan, which takes approximately 1 hour to complete. This is a longitudinal study and you may be asked to repeat these procedures approximately every six months for the duration of this 2 year project.
- Keywords
- 3T MRI, neurodegenerative disease, Alzheimer's disease, spectroscopy, Normal, healthy subject without memory complaint, Not pregnant, MR compatible
- Medical subject headings
- Neurodegenerative Diseases, Cognitive Dysfunction, Alzheimer Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startJun 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Investigators
- Earl A Zimmerman, MD, Study director, Albany Medical CollegeJohn F Schenck, MD, PhD, Principal investigator, GE Global Research Center & Neurosciences Advanced Imaging Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249080
- Sponsor's protocol ID
- AMC-IRB-1599
- Other IDs
- A-13214
- Status last verified
- Aug 2009
- First submitted
- 3 Nov 2005
- Last updated
- 24 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schenck JF, Zimmerman EA. High-field magnetic resonance imaging of brain iron: birth of a biomarker? NMR Biomed. 2004 Nov;17(7):433-45. doi: 10.1002/nbm.922.
PubMed 15523705Schenck JF. Magnetic resonance imaging of brain iron. J Neurol Sci. 2003 Mar 15;207(1-2):99-102. doi: 10.1016/s0022-510x(02)00431-8. No abstract available.
PubMed 12614939Schenck JF. Safety of strong, static magnetic fields. J Magn Reson Imaging. 2000 Jul;12(1):2-19. doi: 10.1002/1522-2586(200007)12:13.0.co;2-v.
PubMed 10931560
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Field MRI of Brain Iron in Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT00249080
- Acronym / sponsor ID
- AMC-IRB-1599
- Keywords
- 3T MRI, neurodegenerative disease, Alzheimer's disease, spectroscopy, Normal, healthy subject without memory complaint, Not pregnant, MR compatible
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jun 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 7 Nov 2005 (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.
Neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis are recognized as a major health concern at the present time. There is information in magnetic resonance imaging (MRI) studies regarding the role of brain iron in normal brain aging that may be enhanced with the use of better scanning equipment and procedures, and by correlating this information with clinical data. This research study aims to develop and evaluate a number of techniques that can potentially improve the effectiveness of three tesla (3T) magnetic resonance imaging of neurodegenerative brain disorders.
Detailed description
Eligibility: A healthy person without memory complaints or someone with neurodegenerative disease. However, the person should not have metal in the body (ie, pacemaker, implants, shrapnel, etc.), should not be pregnant, and should not have claustrophobic anxieties.
Study Procedures: During a regular office visit, a neurologist will perform a routine physical and neurological examination, including your medical and family history, to determine your eligibility for this study. You will then be scheduled for a series of neuropsychological tests, which take between 1 to 1.5 hours, and an MRI scan, which takes approximately 1 hour to complete. This is a longitudinal study and you may be asked to repeat these procedures approximately every six months for the duration of this 2 year project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately equal numbers of subjects with clinically diagnosed Alzheimer's disease, multiple sclerosis, Parkinson's disease and normal controls (age and gender matched).
Key inclusion criteria (2 listed)
- 18 years or older
- Healthy person without memory complaints OR person diagnosed with a neurodegenerative disease (ie, Alzheimer's disease, Parkinson's disease, multiple sclerosis)
Key exclusion criteria (3 listed)
- MR contraindication such as metal in body (ie, pacemaker, implant, shrapnel, etc.)
- Pregnant
- Claustrophobic anxieties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 24 Aug 2009.
- Background: PubMed 15523705Schenck JF, Zimmerman EA. High-field magnetic resonance imaging of brain iron: birth of a biomarker? NMR Biomed. 2004 Nov;17(7):433-45. doi: 10.1002/nbm.922.
- Background: PubMed 12614939Schenck JF. Magnetic resonance imaging of brain iron. J Neurol Sci. 2003 Mar 15;207(1-2):99-102. doi: 10.1016/s0022-510x(02)00431-8. No abstract available.
- Background: PubMed 10931560Schenck JF. Safety of strong, static magnetic fields. J Magn Reson Imaging. 2000 Jul;12(1):2-19. doi: 10.1002/1522-2586(200007)12:13.0.co;2-v.
- The Alzheimer's Center of Albany Medical CenterLink provided by the sponsor.
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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.
Earl A Zimmerman, MD study director
Albany Medical College
John F Schenck, MD, PhD principal investigator
GE Global Research Center & Neurosciences Advanced Imaging Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases and Mild Cognitive Impairment, run by Albany Medical College.
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 2 inclusion and 3 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 24 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249080, which also lists 3 linked publications.
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 24 Aug 2009.