UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047522 |
|---|---|
| Receipt number | R000054129 |
| Scientific Title | A multicenter study to elucidate the biological basis of behavioral and psychological symptoms of dementia (BPSD) using prospectively collected data of neuroimaging and blood biomarkers and to establish a method to predict the effects of non-pharmacological treatment for BPSD |
| Date of disclosure of the study information | 2022/04/19 |
| Last modified on | 2022/11/16 12:14:26 |
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Basic information
Public title
A multicenter study to elucidate the biological basis of behavioral and psychological symptoms of dementia (BPSD) using prospectively collected data of neuroimaging and blood biomarkers and to establish a method to predict the effects of non-pharmacological treatment for BPSD
Acronym
J-BIRD-PNB Study
Scientific Title
A multicenter study to elucidate the biological basis of behavioral and psychological symptoms of dementia (BPSD) using prospectively collected data of neuroimaging and blood biomarkers and to establish a method to predict the effects of non-pharmacological treatment for BPSD
Scientific Title:Acronym
J-BIRD-PNB Study
Region
| Japan |
Condition
Condition
Alzheimer's disease, dementia with Lewy bodies
Classification by specialty
| Neurology | Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the biological basis of behavioral and psychological symptoms (BPSD) in Alzheimer's disease and dementia with Lewy bodies using neuroimaging and blood biomarker data. To establish methods to predict the efficacy of non-pharmacological treatments for BPSD using neuroimaging blood data, blood biomarker data, and clinical data.
Basic objectives2
Others
Basic objectives -Others
Construction of a cohort of patients with remarkable behavioral and psychological symptoms of dementia
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sub-item scores of the Neuropsychiatric Inventory (NPI)
Key secondary outcomes
NPI total score
NPIQ total score
Information on BPSD and care in real life
Empathy disorder rating scale score
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)Patients who meet the diagnostic criteria for AD or DLB
2) Age at enrollment: between 50 and 85 years old
3) A total score of 10 or more on the Neuropsychiatric Inventory (NPI) excluding eating behavior abnormalities, and a score of 2 or more on any of the following sub-items: delusions, hallucinations, agitation, depression, anxiety, irritability and sleep disorders.
4)Global CDR score of 0.5, 1 or 2
5)Right-handed
6)There is a family caregiver who lives at home, meets with the patient at least twice a week, and responds appropriately to the patient's BPSD.
Key exclusion criteria
1)Patients who have abnormal findings on brain MRI that indicate other abnormalities than AD or DLB
2)Patients who have history of organic brain diseases, such as head trauma, subarachnoid hemorrhage, or neurosurgery
3)Patients who have history of psychiatric disorders, such as schizophrenia, bipolar disorder, alcoholism, or developmental disorder
4)Patients who have a serious physical illness
5)Patients who the researchers consider unsuitable for the research participants
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kazui |
Organization
Kochi Medical School,Kochi University,
Division name
Department of Neuropsychiatry
Zip code
783-8505
Address
Kohasu Oko-cho,Nankoku,Kochi,Japan
TEL
088-880-2359
kazui@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kazui |
Organization
Kochi Medical School,Kochi University,
Division name
Department of Neuropsychiatry
Zip code
783-8505
Address
Kohasu Oko-cho,Nankoku,Kochi,Japan
TEL
088-880-2359
Homepage URL
kazui@kochi-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School,Kochi University,
Address
Kohasu Oko-cho,Nankoku,Kochi,Japan
Tel
088-880-2359
kms-info@kochi-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 19 | 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
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The project will prospectively collect information on BPSD assessment, multiple neuroimaging test results, multiple blood biomarker test results, cognitive function, and living environment for Alzheimer's disease and dementia with Lewy bodies for two years, and clarify the relationship between BPSD and neuroimaging and blood biomarkers based on the data obtained. In addition, we will instruct caregivers on how to appropriately respond to BPSD and how to adjust the environment, and record the effects of BPSD reduction.
Management information
Registered date
| 2022 | Year | 04 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054129
