UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052928 |
|---|---|
| Receipt number | R000060257 |
| Scientific Title | A Retrospective Study to Identify Time to EOAD Diagnosis in Japan |
| Date of disclosure of the study information | 2023/11/28 |
| Last modified on | 2024/12/05 15:59:12 |
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Basic information
Public title
A Retrospective Study to Identify Time to EOAD Diagnosis in Japan
Acronym
A Retrospective Study to Identify Time to EOAD Diagnosis in Japan
Scientific Title
A Retrospective Study to Identify Time to EOAD Diagnosis in Japan
Scientific Title:Acronym
A Retrospective Study to Identify Time to EOAD Diagnosis in Japan
Region
| Japan |
Condition
Condition
early-onset Alzheimer's Disease
late-onset Alzheimer's Disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to identify time to EOAD as well as LOAD diagnoses, and to explore factors associated with these diagnostic durations.
Basic objectives2
Others
Basic objectives -Others
The objectives of this study are to identify time from onset to EOAD diagnosis as well as time in each diagnostic process taken by EOAD patients in Japan, compared to those of LOAD patients. Furthermore, the objectives of this study include investigation of factors associated with these diagnostic durations.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify time to AD diagnosis in Japan.
Key secondary outcomes
To explore factors associated with diagnostic durations of AD in Japan.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects receiving a diagnosis of "Probable AD dementia", "MCI due to AD", or an equivalent diagnosis at a given participating university hospital between April 2011 and March 2023. Subjects were included regardless of brain amyloid-beta pathology, typically confirmed via either imaging or CSF tests.
2) AD onset was between 18 to 79 years of age.
Key exclusion criteria
1)Subjects whose onset or time of diagnosis could not be reliably identified.
2)Subjects with a diagnosis of dementia due to other neurodegenerative diseases.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kensaku |
| Middle name | |
| Last name | Kasuga |
Organization
Brain Research Institute, Niigata University
Division name
Department of Molecular Genetics, Center for Bioresources
Zip code
951-8585
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
025-227-2344
ken39@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensaku |
| Middle name | |
| Last name | Kasuga |
Organization
Brain Research Institute, Niigata University
Division name
Department of Molecular Genetics, Center for Bioresources
Zip code
951-8585
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL
025-227-2344
Homepage URL
ken39@bri.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Kensaku Kasuga
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan
Tel
025-227-2625
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（新潟県） 、東京医科大学（東京都）、 聖マリアンナ医科大学（神奈川県） 、大分大学医学部（大分県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
159
Results
The time from onset to diagnosis for EOAD was significantly greater than that for LOAD. Of which, the time from onset to initial medical visit was significantly greater for EOAD (n=74, 89.0+/-74.2 weeks, P=0.0242) as compared to LOAD (n=46, 57.6+/-71.5 weeks).
Results date posted
| 2024 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
83 EOAD patients (63.4+/-6.5 years of age), 63 LOAD patients (79.0+/-4.9 years of age)
Participant flow
159 patients were enrolled into this study (EOAD: 86, LOAD: 73), of which 13 patients (EOAD: 3, LOAD: 10) were excluded after enrollment due to unmet selection criteria. Furthermore, 8 patients (EOAD: 4, LOAD: 4) were excluded since they were found unsuitable, considering the purpose of the study. 138 patients (EOAD: 79, LOAD: 59) were included in the analysis.
Adverse events
Outcome measures
The time from onset to diagnosis in EOAD and LOAD was 138.3+/-91.0 weeks (n=79) and 99.6+/-81.5 weeks (n=59) (P=0.0108, Student's t-test), demonstrating that it takes a longer time for definite diagnosis in EOAD compared to LOAD.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 11 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 22 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 25 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060257
