An observational study in Alzheimer's Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 2 sites in United States. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
The study will investigate the possibility of detecting early signs of Alzheimer's 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. Alzheimer's disease, a progressive disease, is a major cause of functional disability and institutionalization, affecting 4.5 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 Alzheimer's disease and who are in good health may be eligible for this study. Twenty patients will be recruited from Johns Hopkins' Alzheimer's 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 patient's 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...
Objective:
The objective of the proposed pilot study is to investigate the possibility of detecting early signs of Alzheimer's 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 Alzheimer's patients with mild cognitive impairment. As reference, an age-matched control group (n=20) 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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 40 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
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EXCLUSION CRITERIA:
This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.
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National Institute of Neurological Disorders and Stroke (NINDS)