Alzheimer'
Conditions
Interventions
This is an observational cohort study. There is no intervention. But we will perform this research in comliance with the level of invasive research with intervention.
Sponsors
Natinal Center of Neurology and Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants should fulfill the followings: 1) 50 years old or older, regardless of gender 2) Essentially, the participants themselves must understand the contents of the research, and a written informed consent should be obtained by their own free will. But, if a participant may not have the consent ability due to cognitive decline, we will obtain a written consent from a representative such as a study partner. 3) The participant should agree with on-schedule visits and clinical examinations. 4) Clinical examinations should not reveal abnormalities such as malignancies that may interfere with ongoing research participation. 5) Visual acuity, hearing and writing ability are maintained to the extent that they do not affect cognitive function tests. 6) Participants agree with invasive examinations including DAT-SPECT, amyloid PET, lumbar puncture and blood collection. 7) The participant has an informant (study partner). Study partners live at home, are healthy, have contact with participants for more than 10 hours a week, and the same study partner can accompany all visits during the observation period.
Exclusion criteria
Exclusion criteria: 1) Existence of significant diseases that may affect the central nervous system other than the target disease of this research, such as neurodegenerative diseases (other than AD/PD related diseases), severe cerebrovascular diseases, neuroimmune diseases, and head injuries. 2) Existence of significant MRI abnormalities, which may affect cognitive function. 3) Drug-induced parkinsonism is likely. 4) SWEDD (Scans Without Evidence of Dopaminergic Deficit). 5) Contraindications to MRI. 6) Hypersensitivity to tracers such as 18F-GE067 and 123I-FP-CIT. 7) Medical history of schizophrenia; major depressive disorder or bipolar disorder defined by DSM-IV within a year. 8) A history of alcoholism and drug dependence defined by DSM-IV within the past two years. 9) Severe mental symptoms that make it difficult to comply with the protocol within the past three months 10) Serious systemic disease or an unstable disease. 11) Systemic disease affecting cognitive function such as infectious disease and metabolic disease. 12)Participant admitted to a nursing home or another hospital. 13) If a participant is planning to participate in a clinical intervention trial at the time of enrollment. 14) Any case in which a researcher or consulting doctor judges that the study is not appropriate for a particular participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of neural network functions and brain structures by means of MRI analysis, especially from the viewpoints of the PADNI concept, putting emphasis on chronological changes of the measures and their differences across groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Transition rate from preclinical AD to MCI or AD 2. Transition rate from prodromal PD/DLB to PD or DLB 3. Changes of biomarkers including blood and cerebrospinal fluid 4. Changes of amyloid accumulation in amyloid PET 5. SBR of DAT-SPECT and statistical index of image analysis 6. Clinical index: Correlation between each group or correlation between MRI evaluation index and clinical indicators in each group 7. If a participant dies during the study, we will consider an autopsy. | — |
Countries
Japan
Contacts
Public ContactMayumi Inoue
Natinal Center of Neurology and Psychiatry Integrative Brain Imaging Center
Outcome results
None listed