UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024991 |
|---|---|
| Receipt number | R000028757 |
| Scientific Title | The investigation of neuropsychiatric symptoms of dementia by the molecular neuroimaging |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2021/11/18 08:56:01 |
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Basic information
Public title
The investigation of neuropsychiatric symptoms of dementia by the molecular neuroimaging
Acronym
The investigation of neuropsychiatric symptoms of dementia by the molecular neuroimaging
Scientific Title
The investigation of neuropsychiatric symptoms of dementia by the molecular neuroimaging
Scientific Title:Acronym
The investigation of neuropsychiatric symptoms of dementia by the molecular neuroimaging
Region
| Japan |
Condition
Condition
Alzheimer's disease, Dementia with Lewy bodies
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the neuropsychiatric symptoms with dementia by MRI, SPECT, and neuropsychological tests, compared with healthy controls.
Basic objectives2
Others
Basic objectives -Others
We investigate the neuropsychiatric symptoms with dementia by MRI, SPECT, and neuropsychological tests, compared with healthy controls.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate the relationships between neuropsychiatric symptoms and MRI, SPECT, and neuropsychological tests in clinical use.
Key secondary outcomes
We investigate neuropsychiatric symptoms and MRI, SPECT, and neuropsychological tests of control subjects, for comparing with dementia patients.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
SPECT, MRI, neuropsychological tests
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a) Dementia patients group
1. Outpatients of the psychiatric department of Nara medical university or Nara medical university hospital dementia-related disease medical center who are diagnosed as Alzheimer's disease or dementia with Lewy bodies based on DSM-5
2. < 85 years of age
b) Healthy control group
1. No history or present diagnosis of any DSM-5 diagnosis or any neurological illness
2. Mini-Mental-State Examination (MMSE) >= 27
3. < 85 years of age
Key exclusion criteria
1. A history of head injury
2. A diagnose of abuse or addiction of drugs
3. A diagnose or history of mental illness based on DSM-5 and neurological illness other than Alzheimer's disease or dementia with Lewy bodies for Dementia patients group
4. No consent ability
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kiwamu |
| Middle name | |
| Last name | Matsuoka |
Organization
Nara medical university
Division name
The department of psychiatry
Zip code
634-8522
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-22-3051
kiwamu@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiwamu |
| Middle name | |
| Last name | Matsuoka |
Organization
Nara medical university
Division name
The department of psychiatry
Zip code
634-8522
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kiwamu@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Nara medical university
Address
840 Shijo-Cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-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
| 2017 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028757
