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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039487
Receipt No. 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 2021/08/15

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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

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 Naotaka
Middle name
Last name Sunada
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 sunadan@takii.kmu.ac.jp

Public contact
Name of contact person
1st name Naotaka
Middle name
Last name Sunada
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 sunadan@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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 naotaka5941@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
2021 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.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


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