UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044819 |
|---|---|
| Receipt number | R000051185 |
| Scientific Title | A Study on the Significance of Biomarker Diagnosis in Patients with Suspected Dementia |
| Date of disclosure of the study information | 2021/07/12 |
| Last modified on | 2024/03/17 12:59:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Significance of Biomarker Diagnosis in Patients with Suspected Dementia
Acronym
FBDSD study
Scientific Title
A Study on the Significance of Biomarker Diagnosis in Patients with Suspected Dementia
Scientific Title:Acronym
FBDSD study
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the usefulness of biomarkers in the diagnosis of dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of clinical diagnosis and biomarker diagnosis
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with normal, MCI, and mild Alzheimer's disease as a result of diagnosis and examination performed within the scope of usual medical diagnosis
Key exclusion criteria
Psychiatric disorders other than dementia, cerebrovascular disorders that may affect cognitive function, suspected neurodegenerative disorders other than Alzheimer's disease, cases of delirium or drug-induced cognitive dysfunction
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Takechi |
Organization
Fujita Health University School of Medicine
Division name
Department of Geriatrics and Cognitive Disorders
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutukake, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2000
takechi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Takechi |
Organization
Fujita Health University School of Medicine
Division name
Department of Geriatrics and Cognitive Disorders
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutukake, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2000
Homepage URL
takechi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Fujita Health University School of Medicine
Address
1-98 Dengakugakubo, Kutukake, Toyoake, Aichi 470-1192, Japan
Tel
0562-93-2865
f-rib@fujita-hu.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
| 2021 | Year | 07 | Month | 12 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 08 | 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
The clinical diagnosis will be made by performing cognitive function tests, blood tests, imaging tests, and assessment of activities of daily living by family members, which are usually performed in the outpatient memory clinic. In addition, an amyloid PET scan will be performed to compare the clinical diagnosis with the diagnosis after the amyloid PET scan.
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051185
