UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038711 |
|---|---|
| Receipt number | R000044112 |
| Scientific Title | J-TRC onsite study |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2021/03/12 12:46:19 |
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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
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
iwatsubo@m.u-tokyo.ac.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044112
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
