UMIN-CTR Clinical Trial

Basic information
Public title	Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians
Acronym	Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians
Scientific Title	Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians
Scientific Title:Acronym	Research on the treatment needs of patients with dementia with Lewy bodies, their caregivers, and their physicians
Region	Japan

Condition
Condition	Dementia with Lewy bodies (DLB)
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to conduct research related to the treatment needs of DLB patients and their caregivers, as well as physicians' understanding of those treatment needs. Then, the researchers will identify discrepancies in treatment needs between physician and patients/caregivers. In the event of a discrepancy, the researchers will analyze the cause. In addition, the researchers will gain an understanding of the differences in focus and treatment priorities for DLB symptoms among physicians and clinical departments and analyze the factors that contribute to such differences.
Basic objectives2	Others
Basic objectives -Others	Non-interventional observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient-physician and patient-caregiver match rates for "patient's most inconvenient symptom classification" and caregiver-physician match rates for "caregiver's most inconvenient symptom classification"
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criteria for physicians: Attending physicians who are treating DLB patients at the start of the research who also meet any of the following criteria 1) Dementia with Lewy Bodies Society members and physicians of the medical institution to which the member of the group belongs 2) Chief medical adviser/medical adviser of Dementia with Lewy Bodies Support Network or physicians of the medical institution to which the chief medical adviser/medical adviser belongs 3) Physicians who have written review articles or research papers on DLB and physicians of medical institutions to which said physicians belong Inclusion criteria for patients: 1) Patients who meet probable DLB according to the clinical diagnostic criteria for DLB (2017) and are outpatients over the age of 50 who have been treated by their attending physicians for 3 months or longer. 2) Patients who were fully informed about this research in writing and who have given their informed consent in writing at their or their representative's discretion. 3) Patients with caregivers who have given informed consent to participate in this research Inclusion criteria for caregivers 1) Main caregiver (caregiver who primarily takes care of the patient) 2) 20 years of age or older. 3) Caregivers who were fully informed about this research in writing and who have given their informed consent in writing (whether living together or separately with patients)
Key exclusion criteria	Exclusion criteria for patients: 1) Patients with Parkinson's disease with dementia [Parkinson's disease dementia (PDD): Defined as a disease in which Parkinsonism appears more than one year before dementia] 2) Patients who have not been followed up by attending physicians for more than 3 months before their informed consent 3) Patients who received other investigational drugs or clinical research drugs within 4 weeks before the start of this research or patients who have not completed other clinical trials or clinical studies at the time of signing their informed consent. 4) Patients judged by attending physicians as inappropriate for this research
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Ikeda
Organization	Graduate School of Osaka University
Division name	Department of Psychiatry, Graduate School of Medicine
Zip code	565-0871
Address	2-2, Yamadaoka, Suita Osaka Japan
TEL	+81668793051
Email	mikeda@psy.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Manabu Middle name Last name Ikeda
Organization	Graduate School of Osaka University
Division name	Department of Psychiatry, Graduate School of Medicine
Zip code	565-0871
Address	2-2, Yamadaoka, Suita Osaka Japan
TEL	+81668793051
Homepage URL
Email	mikeda@psy.med.osaka-u.ac.jp

Sponsor
Institute	Graduate School of Osaka University
Institute
Department

Funding Source
Organization	Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita Osaka
Tel	+81662108296
Email	handai-nintei@hp-crc.med.osaka-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	2020 Year 09 Month 23 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	No longer recruiting
Date of protocol fixation	2020 Year 07 Month 08 Day
Date of IRB	2020 Year 09 Month 23 Day
Anticipated trial start date	2020 Year 09 Month 23 Day
Last follow-up date	2021 Year 07 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The objective is to conduct research related to the treatment needs of DLB patients and their caregivers, as well as physicians' understanding of those treatment needs. Then, the researchers will identify discrepancies in treatment needs between physician and patients/caregivers. In the event of a discrepancy, the researchers will analyze the cause. In addition, the researchers will gain an understanding of the differences in focus and treatment priorities for DLB symptoms among physicians and clinical departments and analyze the factors that contribute to such differences.

Management information
Registered date	2020 Year 09 Month 18 Day
Last modified on	2021 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047754