UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024509 |
|---|---|
| Receipt number | R000028213 |
| Scientific Title | Investigation of diagnostic biomarkers for dementia |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2024/04/27 12:52:07 |
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Basic information
Public title
Investigation of diagnostic biomarkers for dementia
Acronym
Investigation of diagnostic biomarkers for dementia
Scientific Title
Investigation of diagnostic biomarkers for dementia
Scientific Title:Acronym
Investigation of diagnostic biomarkers for dementia
Region
| Japan |
Condition
Condition
Mild cognitive impairment, Alzheimer's disease, Vascular dementia, Frontotemporal dementia, Dementia with Lewy Bodies and Normal controls
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate diagnostic biomarkers for dementia using biological samples.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to reveal clinical characteristics of biological samples.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments of clinical dementia symptoms, blood and saliva samples for comparison of subjects with dementia and normal controls.
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
Patients with diagnoses of mild cognitive impairment, Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy Bodies, who are inpatients or outpatients. Also, normal controls aged 20 and over, who have not been diagnosed with dementia.
Key exclusion criteria
Severe physical illness
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
kobayashi-n@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
kkondo@jikei.ac.jp
Sponsor or person
Institute
The Jikei 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
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
The Uehara Memorial Foundation and Mitsui Life Social Welfare Foundation
IRB Contact (For public release)
Organization
the Ethics Committees of the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.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
東京慈恵会医科大学附属病院（東京都）、医療法人永光会あいらの森ホスピタル(旧栗野病院)(鹿児島県)/
The Jikei University Hospital (Tokyo), Eiko-kai healthcare corporation Kurino hospital (Kagoshima)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case-control study
Management information
Registered date
| 2016 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028213
