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
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
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
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
