UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044819
Receipt number R000051185
Scientific Title A Study on the Significance of Biomarker Diagnosis in Patients with Suspected Dementia
Date of disclosure of the study information 2021/07/12
Last modified on 2024/03/17 12:59:11

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Basic information

Public title

A Study on the Significance of Biomarker Diagnosis in Patients with Suspected Dementia

Acronym

FBDSD study

Scientific Title

A Study on the Significance of Biomarker Diagnosis in Patients with Suspected Dementia

Scientific Title:Acronym

FBDSD study

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the usefulness of biomarkers in the diagnosis of dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of clinical diagnosis and biomarker diagnosis

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

30 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with normal, MCI, and mild Alzheimer's disease as a result of diagnosis and examination performed within the scope of usual medical diagnosis

Key exclusion criteria

Psychiatric disorders other than dementia, cerebrovascular disorders that may affect cognitive function, suspected neurodegenerative disorders other than Alzheimer's disease, cases of delirium or drug-induced cognitive dysfunction

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hajime
Middle name
Last name Takechi

Organization

Fujita Health University School of Medicine

Division name

Department of Geriatrics and Cognitive Disorders

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-2000

Email

takechi@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Hajime
Middle name
Last name Takechi

Organization

Fujita Health University School of Medicine

Division name

Department of Geriatrics and Cognitive Disorders

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-2000

Homepage URL


Email

takechi@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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

Fujita Health University School of Medicine

Address

1-98 Dengakugakubo, Kutukake, Toyoake, Aichi 470-1192, Japan

Tel

0562-93-2865

Email

f-rib@fujita-hu.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 07 Month 12 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

Completed

Date of protocol fixation

2020 Year 02 Month 18 Day

Date of IRB

2020 Year 02 Month 18 Day

Anticipated trial start date

2021 Year 07 Month 08 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The clinical diagnosis will be made by performing cognitive function tests, blood tests, imaging tests, and assessment of activities of daily living by family members, which are usually performed in the outpatient memory clinic. In addition, an amyloid PET scan will be performed to compare the clinical diagnosis with the diagnosis after the amyloid PET scan.


Management information

Registered date

2021 Year 07 Month 09 Day

Last modified on

2024 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051185


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name