Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413621
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-12-19
Brief Title:
MRI of Alzheimers Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
MRI of Alzheimers Disease Imaging Amyloid Plaques in Persons With and Without Memory Problems
Status:
COMPLETED
Status Verified Date:
2009-10-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will investigate the possibility of detecting early signs of Alzheimers disease using magnetic resonance imaging MRI If plaques types of damage can be imaged by MRI the procedure could be used in clinical trials and may also help in the clinical diagnosis of patients Alzheimers disease a progressive disease is a major cause of functional disability and institutionalization affecting 45 million people in the United States a number that will more than triple by 2030 as the population ages
Patients ages 55 to 90 who have mild symptoms of Alzheimers disease and who are in good health may be eligible for this study Twenty patients will be recruited from Johns Hopkins Alzheimers Disease Research Center There will also be a control group of 20 people without the disease
Healthy patients and volunteers will have a clinical MRI brain scan and a neurological examination at Johns Hopkins Hospital before the 7T MRI scan Also patients will have a Mini-Mental State Examination a standardized test to evaluate memory done at Johns Hopkins within 4 weeks of the 7T MRI This study uses a device situated at the NIH Bethesda campus that operates at a high magnetic field strength of 7 Tesla that is the unit used to measure the strength of a strong magnet The Food and Drug Administration has categorized MRI up to 8 Tesla as not a significant health risk MRI scanning is routinely done at magnetic field strengths up to 4T MRI images are created through the use of a large magnet and radio waves During the procedure patients lie on a table moved into a strong magnetic field They are asked to lie still but can easily hear and speak to research staff A respiratory belt is placed around the chest and a finger probe is placed on the finger to monitor breathing and heart rate For obtaining a better picture a special lightweight coil may be placed on or around the patients head The scan takes from 20 minutes to 2 hours with most scans at 45 to 90 minutes Due to limited experience with the use of 7T MRI and its investigational nature patients will be asked to complete a questionnaire immediately after the study They will be asked about their comfort level and if they experienced unusual sensations Answers will be reviewed with patients by an experienced MRI investigator to get details of any unusual sensations reported If patients experience unusual sensations they are followed up by phone within 24 hours
This study wi
Patients ages 55 to 90 who have mild symptoms of Alzheimers disease and who are in good health may be eligible for this study Twenty patients will be recruited from Johns Hopkins Alzheimers Disease Research Center There will also be a control group of 20 people without the disease
Healthy patients and volunteers will have a clinical MRI brain scan and a neurological examination at Johns Hopkins Hospital before the 7T MRI scan Also patients will have a Mini-Mental State Examination a standardized test to evaluate memory done at Johns Hopkins within 4 weeks of the 7T MRI This study uses a device situated at the NIH Bethesda campus that operates at a high magnetic field strength of 7 Tesla that is the unit used to measure the strength of a strong magnet The Food and Drug Administration has categorized MRI up to 8 Tesla as not a significant health risk MRI scanning is routinely done at magnetic field strengths up to 4T MRI images are created through the use of a large magnet and radio waves During the procedure patients lie on a table moved into a strong magnetic field They are asked to lie still but can easily hear and speak to research staff A respiratory belt is placed around the chest and a finger probe is placed on the finger to monitor breathing and heart rate For obtaining a better picture a special lightweight coil may be placed on or around the patients head The scan takes from 20 minutes to 2 hours with most scans at 45 to 90 minutes Due to limited experience with the use of 7T MRI and its investigational nature patients will be asked to complete a questionnaire immediately after the study They will be asked about their comfort level and if they experienced unusual sensations Answers will be reviewed with patients by an experienced MRI investigator to get details of any unusual sensations reported If patients experience unusual sensations they are followed up by phone within 24 hours
This study wi
Detailed Description:
Objective
The objective of the proposed pilot study is to investigate the possibility of detecting early signs of Alzheimers Disease AD using high field 7T MRI If plaques can be imaged by MRI the procedure could be used as a measure of efficacy in clinical trials of AD and replace more invasive methods such as positron emission tomography PET This procedure might also be helpful in the clinical diagnosis of patients
Study Population
The target population is a group of 20 Alzheimers patients with mild cognitive impairment As reference an age-matched control group n20 will be recruited from the normal adult population
Design
Our working hypothesis is that high resolution MRI at 7T allows detection of amyloid plaques in AD To test this hypothesis subjects from AD and control population will each undergo an MRI at 7T to image brain structure at high resolution Brain cortical structures will then be compared between the two groups and investigated for abnormalities
Outcome Measure
As outcome measure of this study it will be determined if sub cortical plaques typical of AD are detectable with high field MRI
The objective of the proposed pilot study is to investigate the possibility of detecting early signs of Alzheimers Disease AD using high field 7T MRI If plaques can be imaged by MRI the procedure could be used as a measure of efficacy in clinical trials of AD and replace more invasive methods such as positron emission tomography PET This procedure might also be helpful in the clinical diagnosis of patients
Study Population
The target population is a group of 20 Alzheimers patients with mild cognitive impairment As reference an age-matched control group n20 will be recruited from the normal adult population
Design
Our working hypothesis is that high resolution MRI at 7T allows detection of amyloid plaques in AD To test this hypothesis subjects from AD and control population will each undergo an MRI at 7T to image brain structure at high resolution Brain cortical structures will then be compared between the two groups and investigated for abnormalities
Outcome Measure
As outcome measure of this study it will be determined if sub cortical plaques typical of AD are detectable with high field MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-N-0050 | None | None | None |