UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044112 |
|---|---|
| Receipt number | 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 18:28:55 |
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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
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
ihara@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050370
