neurodegenerative diseases
Conditions
Interventions
amyloid PET (18F- Florbetaben 300MBq) Tau PET (18F- PI-2620 185MBq or 18F- PM-PBB3 185MBq) Timing: baseline and 3 years
Sponsors
Keio University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria common to all subjects 1. The subject fully understands the contents of the research and written consent is obtained from the subject. If the attending physician considers that the subject's consent ability is not sufficient, document consent is obtained from the substitute. 2. In this research, we have newly registered the following healthy volunteers and patients who have no audio-visual disorder, normal writing ability and Japanese as their mother tongue. Patients with normal subjects, Alzheimer's disease (AD), mild cognitive impairment (MCI), frontal temporal lobe degeneration (FTLD), head trauma, patients with Parkinson's disease or Parkinson's syndrome, senile psychosis, Lewy body Dementia (DLB) 3. Collaborators who have judged that a study partner is necessary by a doctor are subject to a study partner. Study partner should be conditioned, such as being physically and mentally healthy, having contact with subjects for more than 10 hours a week, accompanying all examination during the observation period etc. 4. No abnormalities that may interfere with participation in medical history, physical examination, general blood test findings. 5. There should be no severe diseases such as interruption or hospital treatment. 6. The woman is not pregnant or nursing. 7. Have the intention and ability to participate in 3 years of research. 8. The subjects agreed to receive MRI, tau PET, amyloid PET, blood test. 9. When taking concomitant restriction medicine, dosage regimen / dose must be stable for more than 12 weeks before screening.
Exclusion criteria
Exclusion criteria: 1. When a cerebral infarction or a local lesion which affects infection or cognitive function is found by MRI at screening. Small infarcts in the deep area and diffuse changes in the white matter allow incorporation except those occurring in specific sites affecting cognitive function, but in principle cortical infarction is excluded. 2. There is a problem to take a MRI imaging due to pacemaker, aneurysm clip, artificial valve, cochlear implant or other magnetic or electrically conductive metal, or claustrophobia. 3. If you have psychiatric symptoms, excitability, behavior abnormalities that make it difficult to follow the protocol within the past 3 months. 4. When suffering from severe systemic disease or unstable disease. 5. There are abnormalities affecting cognitive function in vitamin B 12 deficiency, syphilis, thyroid function. 6. When performing lumbar puncture, if you are taking antiplatelet medications, take the following drug withdrawal period into consideration before the examination. 7. Subject is participating in any treatment drug trials. 8. It is clear that participation in clinical trials of Alzheimer's disease treatment drug is made during the 3-year research period. 9. When taking a combination prohibited medicine such as warfarin. 10. Huntington's disease, multiple cerebral infarction, normal pressure hydrocephalus, brain tumor, epilepsy, paroxysmal disease, subdural hematoma, multiple sclerosis. 11. When there is a history of juvenile onset normal schizophrenia. 12. It is judged by the attending physician not to be appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical/neuropsychological examinations: WMS-R logical memory I & II, MMSE, CDR, FAQ, ADAS-cog, fluency, trail making test A & B(baseline, 1, 2, 3 years), JART (baseline) Magnetic Resonance Imaging of brain (MRI)(baseline, 3 years) Lumbar puncture: CSF is collected at baseline and in 3 years(baseline, 3 years) Blood (baseline, 1, 2, 3 years), urine and feces collection (baseline and 3 years) Amyloid PET and Tau PET imaging Preparation of iN cell and iPS cell APOE genotyping, whole genome sequencing Multi-omics analysis: metabolomics, proteomics, lipidomics | — |
Countries
Japan
Contacts
Public ContactShogyoku Bun
Keio University School of Medicine
Outcome results
None listed