Study on the 18F-AV-1451 PET Image Change in Normal Subjects and Patients with Impaired Cognitive Functio
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0004331
- Lead Sponsor
- Korea Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 380
cognitively normal participants:
1. A patient or guardian complains of cognitive impairment
2. Neuropsychological test confirmed that cognitive ability is lower than age and education
3. Maintain overall cognitive function
4. No problem in daily life
5. Should not be dementia at the discretion of the clinician.
6. The classification of Alzheimer's and Vascular Mild Cognitive Impairment is based on grade 3 of Fazekas criteria for white matter hyperintensities (WMH).
vascaular MCI:
1. A patient or guardian complains of cognitive impairment
2. Neuropsychological test confirmed that cognitive ability is lower than age and education
3. Maintain overall cognitive function
4. No problem in daily life
5. Should not be dementia at the discretion of the clinician.
6. The classification of Alzheimer's and Vascular Mild Cognitive Impairment is based on grade 3 of Fazekas criteria for white matter hyperintensities (WMH).
Alzheimer disease dementia; AD:
1. A person diagnosed with Probable Alzheimer's disorder based on NINCDS-ADRDA Alzheimer's Criteria
2. People positive for Major or Mild Neurocognitive Disorder due to Alzheimer ’s disease based on DSM-V-TR (Diagnostic and statistical manual of mental disorders, 5th)
Vascular dementia; VaD:
Applicable to the probably vascular dementia of the NINDS-AIREN criteria.
Cerebral amyloid angiopathy; CAA:
Have been clinically and imaging diagnosed according to the Modified Boston criteria;
If the subject is 55 years of age or older and have a single bleeding or cortical superficial stenosis (CSS) without any other cause, possible CAAs.
1. Persons found by the tester to be difficult to carry out research due to serious internal diseases;
2. A person who is judged by a tester to have a mental illness that is difficult to take PET photos
3. Persons who undergo heart surgery or have been diagnosed with myocardial infarction within six months of screening
4. Those who have received radiation for diagnostic or therapeutic purposes within 7 days of screening
5. Unregulated Diabetes
6. Premenopausal women who are pregnant, nursing, planning to conceive or not using recognized contraceptives during the study period.
7. Other persons deemed unfit by the Tester to participate in this study
*In addition to the above exclusion criteria, the subjects to be registered at the KIRAMS to conduct eye examination are excluded from the subjects if:
1.a history of infection of the central nerve, or of surgery or brain tumors
2. A history of Parkinson's disease or multiple sclerosis.
3. History of diabetic retinopathy or hypertensive retinopathy
4. The history of retinal surgery
5. In case of history or retinal abnormalities that may affect the thickness of the retina nerve fiber layer
6. In case the characteristics of glaucoma are clearly visible or diagnosed as glaucoma;
7. In case of difficulty in watching housekeeping due to cataracts or confusion of medium
8. Anticipating pressure rise due to right angle closure is expected when an operation is attempted.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of change in the brain region 18F-AV-1451 SUV for 4.5 years in each group
- Secondary Outcome Measures
Name Time Method Pearson correlation coefficient between the change rate of the 18F-AV-1451 SUV and the thickness of the retinal nerve layer around the temporal larynx;Pearson correlation coefficient between the rate of change in brain region 18F-AV-1451 SUV and the rate of change in posterior parietal nerve cells-internal upper layer thickness;Pearson correlation coefficient between the change rate of the 18F-AV-1451 SUV in the brain region and the change rate of the volume of the imperial hemisphere;In the early stages of the brain region (0-10 minutes post injection) 18F-AV-1451 SUV rate of change