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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044112
Receipt No. R000050370
Scientific Title Comparison of depression and apathy in patients with dementia-multicenter investigation-
Date of disclosure of the study information 2021/05/06
Last modified on 2021/05/12

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Basic information
Public title Comparison of depression and apathy in patients with dementia-multicenter investigation-
Acronym Comparison of depression and apathy in patients with dementia
Scientific Title Comparison of depression and apathy in patients with dementia-multicenter investigation-
Scientific Title:Acronym Comparison of depression and apathy in patients with dementia
Region
Japan

Condition
Condition Dementia
Classification by specialty
Neurology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to symptomatologically evaluate depression and apathy in patients with dementia, and to elucidate responsible lesions using brain images and biomarkers.
Basic objectives2 Others
Basic objectives -Others The difference in the pathophysiology of dementia with depression and dementia with apathy will be examined at multicenters.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Apathy Evaluation Scale, Dimensional Apathy Scale, Geriatric depression Inventory, Neuropsychiatric Inventory
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 We select questionnaires to assess depression and apathy and collect new information from patients with dementia. We also perform neuropsychological test and brain imaging on patients to obtain data.
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
40 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria Patients who meet the diagnostic criteria for each dementia type (AD , DLB, FTD etc) and who have undergone MRI or cerebral blood flow SPECT.
Key exclusion criteria Patients with extremely poor medical condition.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Kazushige
Middle name
Last name Ihara
Organization Hirosaki University faculty of medicine
Division name Department social medicine
Zip code 036-8562
Address Zaifu-cho: Hirosaki-shi, Aomori-ken
TEL 0172-39-5041
Email ihara@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Kazushige
Middle name
Last name Ihara
Organization Hirosaki University faculty of medicine
Division name Department social medicine
Zip code 036-8562
Address Zaifu-cho: Hirosaki-shi, Aomori-ken
TEL 0172-39-5041
Homepage URL
Email ihara@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku University hospital, Aizu medical center, Yamagata University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hirosaki University faculty of medicine
Address Zaifu-cho: Hirosaki-shi, Aomori-ken
Tel 0172-39-5295
Email cksenta@hirosaki-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
2021 Year 05 Month 06 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
2021 Year 01 Month 01 Day
Date of IRB
2021 Year 02 Month 05 Day
Anticipated trial start date
2021 Year 02 Month 05 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

Management information
Registered date
2021 Year 05 Month 05 Day
Last modified on
2021 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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