NIPH Clinical Trials Search

Elucidation of the pathophysiological mechanism of dementia and clinical research for creation of drug discovery targets

Basic Information

Recruitment status	Complete: follow-up continuing
Health condition(s) or Problem(s) studied	neurodegenerative diseases
Date of first enrollment	2018/06/01
Target sample size	500
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	amyloid PET (18F- Florbetaben 300MBq) Tau PET (18F- PI-2620 185MBq or 18F- PM-PBB3 185MBq) Timing: baseline and 3 years

Outcome(s)

Primary Outcome

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

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude 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.