臨床研究等提出・公開システム

Elucidation of the mechanism of progression of preclinical Alzheimer's disease by a longitudinal imaging and biomarker cohort study (PAD-TRACK)

PAD-TRACK

Niimi Yoshiki

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

niimiy-crc@h.u-tokyo.ac.jp

Shimazaki Masami

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

+81-3-5800-9113

shimazaki@m.u-tokyo.ac.jp

Recruiting

Jan. 05, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1) Provide written informed consent by free will.
2) If eligibility is qualified, consents to all study procedure is provided.
3) With diagnosis of not dementia and Global Clinical Dementia Rating (CDR) score of 0 or 0.5.
4) Age of ranging from 50 to 85 years at the time of informed consent.
5) Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the participant (contact can be in-person, via telephone or electronic communication).
6) Approximately healthy without severe current or past medical history which hinder research participation.
7) With sufficient eyesight and hearing to undergo neuropsychological examinations.
8) Has sufficient Japanese ability for neuropsychological tests and questionnaires.
9) If a female participant has not undergone sterilization or is within 2 years of menopause: a pregnancy test before amyloid PET is negative.
10) Demonstrate a brain amyloid PET increase above the intermediate (subthreshold) level by the central amyloid PET judgement. The amyloid test result before the screening stage is available, in such case an approval of the principal investigator and PET core is required.

1) Current medical history such as Alzheimer's disease, Parkinson's disease, cerebrovascular dementia, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or history of head trauma with neurological deficit or a structural brain abnormality.
2) History of major depressive disorder or bipolar disorder defined by the DSM-V within the past year at the time of consent, or history within 3 months of psychosis, agitation, or behavior problem which interfere study protocol.
3) Have a history of schizophrenia defined by the DSM-V.
4) Have a history of alcohol or substance use disorder defined by DSM-V within 2 years.
5) In the unstable medical condition judged by the principal investigator that pose risks or that interfere research result or subject's performance. It includes uncontrolled hypertension, uncontrolled diabetes, clinically serious heart, lung, kidney, liver, endocrine, or systemic disease.
6) With an ineligibility judged by the research doctor

Both

preclinical Alzheimer's disease

Use an unapproved PET tracer

Alzheimer's disease, preclinical stage

D000544

PACC, CFI, CDR-SB, and APO-E genotype after stratification by conversion from preclinical AD to MCI.

1) PET results (amyloid)
2) blood biomarker (Amyloid-beta molecular species, p-tau, NfL)
3) paremeter of phisical and social activity (Sleep analysis, motion analysis)

+81-3-5841-0818

Dec. 06, 2021

none