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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name