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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024991
Receipt No. 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 2017/12/12

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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
Middle name
Last name Kiwamu Matsuoka
Organization Nara medical university
Division name The department of psychiatry
Zip code
Address 840 Shijo-Cho, Kashihara, Nara
TEL 0744-22-3051
Email kiwamu@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiwamu Matsuoka
Organization Nara medical university
Division name The department of psychiatry
Zip code
Address 840 Shijo-Cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email kiwamu@naramed-u.ac.jp

Sponsor
Institute Nara medical university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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
2016 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
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
2017 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028757

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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