UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter study to longitudinally collect information on behavioral and psychological symptoms and care of people with dementia in real-life situations and to use these data to calculate the success rates of various strategies for various BPSD
Acronym	BPSD and Care Registry Study
Scientific Title	A multicenter study to longitudinally collect information on behavioral and psychological symptoms and care of people with dementia in real-life situations and to use these data to calculate the success rates of various strategies for various BPSD
Scientific Title:Acronym	BPSD and Care Registry Study
Region	Japan

Condition
Condition	Alzheimer's disease, dementia with Lewy bodies, frontotemporal lobar degeneration, vascular dementia
Classification by specialty	Neurology Psychiatry Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify which behavioral and psychological symptoms of dementia (BPSD) are troubling to dementia caregivers in real-life situations and how they respond to those BPSDs, and the transition of BPSDs.
Basic objectives2	Others
Basic objectives -Others	To identify the success rate of various methods to BPSD.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Data to be collected every 3 months for 2 years on the BPSD that are troublesome to caregivers of people with dementia in real-life situations and the actual care methods they have used in response to these BPSD.
Key secondary outcomes	Each subitem score of the Neuropsychiatric Inventory (NPI), recorded longitudinally every 3 months for 2 years

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who meet the diagnostic criteria for dementia or mild cognitive impairment (detailed diagnostic criteria are provided in the study protocol). 2. Patients who meet the diagnostic criteria for Alzheimer's disease, dementia with Lewy bodies, frontotemporal lobar degeneration, or vascular dementia (detailed diagnostic criteria are described in the research protocol). However, for the dementia item of each diagnostic criterion, mild cognitive impairment is also acceptable. 3. There are family members, medical staff, or caregivers who are familiar with the BPSD information of the patients and the actual care methods being used. 4. There are no physical illnesses that significantly affect the BPSD. 5. There are no severe coexisting physical illnesses or living conditions that are likely to render them unobservable during the two-year study.
Key exclusion criteria	None.
Target sample size	960

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
Email	kazui@kochi-u.ac.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Akamatsu
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
Email	m-akamatsu@kochi-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Kochi Medical School, Kochi University
Institute
Department

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	Japan

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
Tel	088-880-2359
Email	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	高知大学医学部附属病院（高知県）/ Kochi University Hospital (Kochi Prefecture)

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 16 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	2020 Year 06 Month 24 Day
Date of IRB	2020 Year 06 Month 24 Day
Anticipated trial start date	2020 Year 06 Month 24 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will identify BPSD that are frequently observed in real-life situations. We will also identify the care provided for these BPSD. We will also use BPSD data collected longitudinally every 3 months to identify how each BPSD fluctuates. Furthermore, we will utilize the data collected in this study and publish more and more reliable BPSD methods on Dementia Chie-no-wa website.

Management information
Registered date	2022 Year 11 Month 16 Day
Last modified on	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046300