SD-BATON

JRCT ID: jRCTs031210288

Registered date:30/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cognitively unimpaired individuals, MCI, Dementia (AD and non-AD, including DLB and FTLD)
• Date of first enrollment: 06/10/2021
• Target sample size: 450
• Study type: Interventional
• Intervention(s): Amyloid beta-PET, Tau-PET, FDG-PET, MRI, MEG, blood sampling, neuropsychological test, questionnaire

Outcome(s)

Primary Outcome

1) Relationships of A-T-N(Amyloid, Tau, Neurodegeneration) and other dementia-related biomarkers (imaging and blood-based biomarkers) with clinical symptoms.
2) Performances of the blood-based A-T-N and other biomarkers when corresponding imaging data (e.g. PET) are used as the standard of truth (SOT). Also, correlations between the blood-based and imaging biomarkers will be evaluated.

Secondary Outcome

1) Using longitudinal observation data, factors (e.g. age, gender, cognitive function, lifestyle, risk factors, genome) that affect disease progression such as the Amyloid beta and tau accumulation, neurodegeneration, and cognitive decline will be quantitatively analyzed. Also, interactions of overlapping pathologies including, vascular lesions and DLB-related pathophysiological changes are analyzed.
2) An integrated stratification algorithm that can estimate the risk of dementia in asymptomatic individuals, and can predict a type of dementia and its progression, will be developed and validated.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 90age old
• Gender: Both

Include criteria

Cognitively unimpaired individuals:A person who has no complaint about memory, and those who have complaints but do not show obvious abnormalities in cognitive function tests. Age is 20 to 90 years old, regardless of gender.
Patients: AD, MCI, DLB, FTLD, VaD, PSP, CBS, PPA, iNPH, elderly tauopathy, and other neurodegenerative diseases that cause dementia. Age is up to 90 years (regardless of age limit and gender)
1) Written informed consent is obtained. If a subject's cognitive ability is considered to be declined to understand the consent, his/her family or legally acceptable representative must provide the written informed consent.
2) A subject with good general condition, who has no problem to perform all necessary examinations.
3) Community-dwelling individuals and outpatients of the hospitals which are involved in the project. Participants for the J-TRC and Nagoya University cohort clinical studies who meet the participation criteria for this study with reference to the test results already conducted.
4) Participants for the NCGG-SGS cohort who meet the participation criteria of this research with reference to the test results that have already been conducted.

Exclude criteria

1) Clinical history of brain tumors, traumatic brain injury, or progressive neurodegenerative disorders other than dementia. However, cerebrovascular dementia is not excluded.
2) Use of medications with antidepressants or antipsychotics. History of alcohol or other drug addiction. Any uncontrolled significant medical condition, abnormal thyroid function, vitamin B1 deficiency, or vitaminB12 deficiency. Use of therapeutic agents for dementia such as donepezil and galantamine does not affect the selection of subjects.
3) Significant deformity/disorders of the spine or hip joint that causes pain or discomfort during examinations.
4) Contraindications to MRI imaging such as, internal implants that operate electrically, magnetically or mechanically. E.g., cardiac pacemakers, internal nerve stimulators, bone growth stimulators, internal defibrillators, and cochlear implants.

Related Information

• Primary Sponsor: Nakamura Akinori