UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042641
Receipt number R000048656
Scientific Title Study on fluid/imaging database for dementia
Date of disclosure of the study information 2020/12/07
Last modified on 2022/06/06 08:05:05

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Basic information

Public title

Study on fluid/imaging database for dementia

Acronym

Fluid/imaging DB for dementia

Scientific Title

Study on fluid/imaging database for dementia

Scientific Title:Acronym

Fluid/imaging DB for dementia

Region

Japan


Condition

Condition

Dementias

Classification by specialty

Neurology Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the utilization of blood data for amyloid and tau to distinguish the pathophysiology characteristic of dementias using CSF and PET images

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Elucidation of pathophysiology of the diseases by examining the characters of CSF, blood and PET images for amyloid and tau.

Key secondary outcomes

Correlation of the tracer binding with psychological and MRI data


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

Other

Interventions/Control_1

PET measurement after intravenous tracer injection

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Healthy participants aged 20 to 90 years
2.Individuals who have no history of psychiatric disease
3.Individuals who are right-handed
4.Individuals who are consent to participate in this study
5.Critetria for elderly subject: 1) Individuals with Mini-mental state examination scores over 26 at screening, 2) Individuals with Clinical dementia rating scale score 0, 3)Individuals whose ADL is normal without any memory problems
6. Patients with dementias (aged 20 to 90 years)

Key exclusion criteria

1.Individuals who have a history of traumatic brain injury with an unconsciousness lasting more than 5 minutes
2.Individuals who have a history of organic brain disease
3.Individuals who have a history of substance dependence
4.Individuals who are taking central nervous system stimulants
5.Individuals who have a history of disorders of consciousness and/or seizure
6.Individuals who have a chronic headache
7.Individuals who have a risk for MRI scan
8. Individuals who are considered unsuitable by doctors in charge

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Yasuomi
Middle name
Last name Ouchi

Organization

Hamamatsu University School of Medicine

Division name

Department of Biofunctional Imaging

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan

TEL

053-435-2466

Email

ouchi@hama-med.ac.jp


Public contact

Name of contact person

1st name Yasuomi
Middle name
Last name Ouchi

Organization

Hamamatsu University School of Medicine

Division name

Department of Biofunctional Imaging

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan

TEL

053-435-2466

Homepage URL


Email

ouchi@hama-med.ac.jp


Sponsor or person

Institute

Department of Biofunctional Imaging, Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hamamatsu Medical Photonics Foundation
Hamamatsu Photonics KK

Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB, Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan

Tel

053-435-2680

Email

rinri@hama-med.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

浜松PET診断センター(静岡県)


Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 07 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

25

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

2020 Year 08 Month 17 Day

Date of IRB

2020 Year 08 Month 28 Day

Anticipated trial start date

2020 Year 12 Month 15 Day

Last follow-up date

2026 Year 03 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 03 Day

Last modified on

2022 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name