臨床研究等提出・公開システム

Stratification of Dementia with Biomarkers for Amyloid, Tau and other Neuropathological changes (SD-BATON)

SD-BATON (SD-BATON)

Nakamura Akinori

National Center for Geriatrics and Gerontology

7-430 Morioka, Obu, Aichi, Japan

nakamura@ncgg.go.jp

Nakamura Akinori

National Center for Geriatrics and Gerontology

7-430 Morioka, Obu, Aichi, Japan

+81-562-46-2311

nakamura@ncgg.go.jp

Recruiting

Aug. 30, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

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.

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.

Both

Cognitively unimpaired individuals, MCI, Dementia (AD and non-AD, including DLB and FTLD)

Amyloid beta-PET, Tau-PET, FDG-PET, MRI, MEG, blood sampling, neuropsychological test, questionnaire

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.

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.

+81-43-206-4706

July. 30, 2021

Yes

1) By participating in multiple clinical trials, data is shared as much as possible to avoid unnecessary duplication of tests.This study allows data sharing with other research projects(J-TRC(Public title;J-TRC onsite study. Reception number is No.1396),AMED niimi Group (AMED Research and Development Number is 21dk0207054s0201..Public title; Elucidation of the mechanism of progression of preclinical Alzheimer` s disease by a longitudinal imaging and biomarker cohort study.), Tokyo Metropolitan Geriatric Medical Center (Research theme 21-35 of Research and Development expenses of National Center for Geriatrics and Gerontology. Public title;Determinant of MCI Reversion/Conversion), AMED tokuda Group (Public english title is unknown),Tohoku University(Public title;Study on usefulness of [18F]SMBT-1 in stratification of dementias (SMBTSD). Trial ID is jRCTs031210602), Nagoya University (Public title; Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease (NaT-PROBEi) (Trial ID is jRCTs041190126), and Development of prodromal biomarkers in patients with Parkinson's disease and dementia with lewy bodies by analyzing body fluid and medical records,and Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms, and studies with unknown English title), if available. Also, this study and ADSAT(Public title;A dementia study by amyloid and tau PET. Trial ID is jRCTs031180219) are not intended to participate in both, data sharing is possible. 2) This study allows sharing of data and samples with domestic and international research collaborators and companies. MK-6240 PET and related data will be provided to Lantheus Holdings, Inc., which has a license for MK-6240. 3) This study allows data sharing with the research database planned by AMED.

None