Elucidation of the pathophysiological mechanism of dementia
- Conditions
- neurodegenerative diseases
- Registration Number
- JPRN-jRCTs031180225
- Lead Sponsor
- Ito Daisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
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, written consent is obtained from the substitute.
2. The following healthy volunteers and patients who speak Japanese as their mother language, have normal writing abilities, and have no audio-visual disorders. However, subjects who are unable to write do to neurodegenerative diseases are allowed to participate in the research.
Healthy subjects, patients with Alzheimer's disease (AD), mild cognitive impairment (MCI), frontal temporal lobe degeneration (FTLD), head trauma, Parkinson's disease or Parkinson's syndrome, senile psychosis, Lewy body Dementia (DLB)
3. Subjects who have been judged by the doctor that a study partner is necessary, must have a study partner. The study partner must satisfy the following conditions. The study partner is physically and mentally healthy, has contact with the subject for more than 10 hours a week, and can accompany all examinations during the observation period, etc.
4. The subject's medical history, physical examination results, general blood test findings do not interfere with the subject's participation in the research.
5. The subject carries no severe diseases which may cause interruption during the research or which may need hospital treatment.
6. Women participating in the research are not pregnant or nursing.
7. The subject has the intention and ability to participate in the research for 3 years.
8. The subject agrees to receive MRI, tau PET, amyloid PET, and the blood test.
9. When taking restricted concomitant medicine, the dosage regimen / dose must be stable for more than 12 weeks before screening.
1. When an infection, a cerebral infarction or a local lesion, which affects the cognitive function, is found by MRI during screening. Small infarcts in the deep area and diffuse changes in the white matter are allowed, however those occurring in specific sites which affect the cognitive function, as well as principle cortical infarctions are excluded.
2. When there is a problem in taking an MRI imaging, due to pacemaker, aneurysm clip, artificial valve, cochlear implant or other magnetic or electrically conductive metal, or claustrophobia.
3. The subject has psychiatric symptoms, excitability, behavior abnormalities within the past 3 months, which make it difficult to follow the protocol.
4. The subject suffers from a severe systemic disease or an unstable disease.
5. The subject has syphilis, or the subject's thyroid function affects the cognitive function.
6. When performing lumbar puncture, if the subject takes antiplatelet medications, the withdrawal period before the examination should be considered.
7. The subject is not participating in any treatment drug trials.
8. The subject is planning to participate in therapeutic clinical trials of Alzheimer's disease during the 3-year research period.
9. When taking a prohibited concomitant medicine such as warfarin.
10. The subject has 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 that the subject's participation is not appropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method europsychological examinations: WMS-R logical memory I & II, MMSE, CDR, FAQ, ADAS-cog, fluency, TMT A & B, Cognition Quotient test(baseline, 1, 2, 3 years), JART (baseline) <br>Magnetic Resonance Imaging of the brain (MRI)(baseline, 3 years) <br>Lumbar puncture: CSF is collected at the baseline and the 3rd year(baseline, 3 years) <br>Blood, urine (baseline, 1, 2, 3 years) and feces collection (baseline and 3 years) <br>Amyloid PET and Tau PET imaging <br>Preparation of iN cell and iPS cell <br>APOE genotyping, whole genome sequencing <br>Multi-omics analysis: metabolomics, proteomics, lipidomics
- Secondary Outcome Measures
Name Time Method The efficacy and safety of Tau PET imaging