UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055066 |
|---|---|
| Receipt number | R000062898 |
| Scientific Title | Dominantly inherited Alzheimer's network (DIAN) Japan Study |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/08/07 13:28:04 |
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Basic information
Public title
Dominantly inherited Alzheimer's network (DIAN) Japan Study
Acronym
DIAN-Japan Study
Scientific Title
Dominantly inherited Alzheimer's network (DIAN) Japan Study
Scientific Title:Acronym
DIAN-Japan Study
Region
| Japan |
Condition
Condition
Alzheimer's diseasse
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to identify natural history of dominantly inherited Alzheimer's disease with pathogenic mutation.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to identify potential biomarkers that may predict the development of Alzheimer's disease in people who carry an Alzheimer's mutation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Dementia Rating (CDR)
Key secondary outcomes
CSF and blood biomarkers, PET, MRI, cognitive tests
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Written informed consent obtained from participant and collateral source prior to any study-related procedures.
Aged 18 (inclusive) or older and the child of an affected individual (clinically or by testing) in a pedigree with a known mutation for ADAD.
Cognitively normal to very mild or mild cognitive impairment (CDR score range 0-1.0).
Has study partner who are not their full-blooded siblings who can serve as collateral sources for the study.
Fluent in a language at about the 6th grade level or above.
Key exclusion criteria
Under age 18
Medical or psychiatric illness that would interfere in completing initial and follow-up visits
Requires nursing home level care
Has no one who can serve as a study informant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ikeuchi |
Organization
Niigata University
Division name
Brain Research Institute
Zip code
951-8585
Address
1-757 Asahimachi, Niigata
TEL
025-227-2344
ikeuchi@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ikeuchi |
Organization
Niigata University
Division name
Brain Research Institute
Zip code
951-8585
Address
1-757 Asahimachi, Niigata
TEL
025-227-2344
Homepage URL
dian-j@bri.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
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
Ethics committee, Niigata University
Address
1-754 Asahimachi, Niigata
Tel
025-368-9345
ethics@adm.niigata-u.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
新潟大学医歯学総合病院（新潟県）、東京大学医学部付属病院（東京都）、東京都健康長寿医療センター（東京都）、神戸市立医療センター中央市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062898
