UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039487
Receipt number R000044975
Scientific Title Search and verification test of genome and bio-markers for the purpose of constructing an individualized treatment algorithm for dementia and mild cognitive impairment
Date of disclosure of the study information 2020/03/01
Last modified on 2023/09/15 17:16:04

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Basic information

Public title

Search and verification test of genome and bio-markers for the purpose of constructing an individualized treatment algorithm for dementia and mild cognitive impairment

Acronym

Precision medicine research in dementia and mild cognitive impairment

Scientific Title

Search and verification test of genome and bio-markers for the purpose of constructing an individualized treatment algorithm for dementia and mild cognitive impairment

Scientific Title:Acronym

Precision medicine research in dementia and mild cognitive impairment

Region

Japan


Condition

Condition

Major or Mild Neurocognitive Disorder Due to Alzheimer's Disease, Major or Mild Frontotemporal Neurocognitive Disorder, Major or Mild Neurocognitive Disorder with Lewy Bodies, Major or Mild Vascular Neurocognitive Disorder, Major or Mild Neurocognitive Disorder Due to Traumatic Brain Injury, Major or Mild Neurocognitive Disorder Due to Prion disease, Major or Mild Neurocognitive Disorder Due to Parkinson's Disease, Major or Mild Neurocognitive Disorder Due to Huntington's Disease, Major or Mild Neurocognitive Disorder Due to Multiple System Atrophy, Senile Dementia or Mild Cognitive Impairment of the Neurofibrillary Tangle Type, Major or Mild Neurocognitive Disorder Due to Normal Pressure Hydrocephalus, Cognitive Impairment Due to Delirium

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

It aims to create an individualized treatment algorithm in each dementia and mild cognitive impairment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cognitive Function Evaluation : Mini-Mental State Examination (MMSE)

Key secondary outcomes

NPI-Brief Questionnaire Form (NPI-Q)


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Person diagnosed with dementia or mild cognitive impairment with DSM-IV-TR or DSM-5
2. Person diagnosed with cognitive impairment due to delirium with DSM-IV-TR or DSM-5
3. Person whose age is 20 years old or older
4. Person who gained consent by free will with document

Key exclusion criteria

1. Person who cannot obtain consent from the person or his/her behalf
2. Person who is deemed ineligible by the principal investigator or sharing researcher

Target sample size

1120


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Murase

Organization

Kansai Medical University

Division name

Department of Neuropsychiatry

Zip code

570-8507

Address

10-15 Fumizono-cho Moriguchi Osaka

TEL

06-6992-1001

Email

murasey@takii.kmu.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Murase

Organization

Kansai Medical University

Division name

Department of Neuropsychiatry

Zip code

570-8507

Address

10-15 Fumizono-cho Moriguchi Osaka

TEL

06-6992-1001

Homepage URL


Email

murasey@takii.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

Mostly self-procurement
Ministry of education

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

Kansai Medical University General Medical Center Ethics Review Committee

Address

10-15 fumizono-cho, Moriguchi Osaka, 570-8507, Japan

Tel

06-6992-1001

Email

yuji.mumu1983@gmail.com


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

2020 Year 03 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

2020 Year 02 Month 14 Day

Date of IRB

2020 Year 07 Month 16 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2025 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The aim of this study is precision medicine for dementia and mild cognitive impairment based on clinical background, genetic polymorphism, blood biomarkers such as inflammation-related factors and neuroplasticity-related factors, quantitative EEG of dementia and mild cognitive impairment.


Management information

Registered date

2020 Year 02 Month 14 Day

Last modified on

2023 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name