UMIN-CTR Clinical Trial

Basic information
Public title	J-TRC onsite study
Acronym	J-TRC-OS
Scientific Title	J-TRC onsite study
Scientific Title:Acronym	J-TRC-OS
Region	Japan

Condition
Condition	preclinical and prodromal Alzheimer's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To construct a sustainable and effective recruiting system for the clinical trials of disease-modifying therapies in preclinical and prodromal Alzheimer's disease.
Basic objectives2	Others
Basic objectives -Others	Construction of a trial ready cohort of preclinical and prodromal AD participants.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of amyloid risk scores based on cognitive scores (e.g., PACC), APOE genotype, family history, age etc.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Provision of signed and dated informed consent form 2. Stated availability and willingness to comply with all study procedures until referred to a clinical trial 3. Age 50-85 (inclusive) 4. Global CDR score of 0 or 0.5 and no diagnosis of dementia.
Key exclusion criteria	1. Treatment with another anti-amyloid investigational drug or other intervention within 12 months (exception allowed) 2. Enrolled in another interventional clinical trial within the last 12 weeks
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Iwatsubo
Organization	The University of Tokyo
Division name	Neuropathology
Zip code	113-0033
Address	7-3-1 Hongo Bunkyoku Tokyo
TEL	03-5841-3541
Email	iwatsubo@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Iwatsubo
Organization	The University of Tokyo
Division name	Neuropathology
Zip code	113-0033
Address	7-3-1 Hongo Bunkyoku Tokyo
TEL	03-5841-3541
Homepage URL
Email	iwatsubo@m.u-tokyo.ac.jp

Sponsor
Institute	AMED
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo
Address	7-3-1 Hongo Bunkyoku Tokyo
Tel	03-5841-3575
Email	ethics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 12 Month 09 Day
Date of IRB	2019 Year 12 Month 19 Day
Anticipated trial start date	2020 Year 02 Month 14 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cognitive assessment including PACC, plasma amyloid beta assessment and amyloid PET scan at baseline. Amyloid PET positive individuals will be followed up by cognitive and blood assessments every 1 year.

Management information
Registered date	2019 Year 11 Month 28 Day
Last modified on	2021 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044112