UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014224 |
|---|---|
| Receipt number | R000016567 |
| Scientific Title | The evaluation of the efficacy of DIMENSION (Diagnosis Method of Neuronal Dysfunction) to diagnosis of Alzheimer's disease |
| Date of disclosure of the study information | 2014/06/11 |
| Last modified on | 2019/12/02 08:05:10 |
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Basic information
Public title
The evaluation of the efficacy of DIMENSION (Diagnosis Method of Neuronal Dysfunction) to diagnosis of Alzheimer's disease
Acronym
Usefulness to Alzheimer's disease diagnosis of DIMENSION (Diagnosis Method of Neuronal Dysfunction)
Scientific Title
The evaluation of the efficacy of DIMENSION (Diagnosis Method of Neuronal Dysfunction) to diagnosis of Alzheimer's disease
Scientific Title:Acronym
Usefulness to Alzheimer's disease diagnosis of DIMENSION (Diagnosis Method of Neuronal Dysfunction)
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the usefulness of DIMENSION which is the method of computer analysis for the electroencephalogram by comparison of relation with the various inspection data for the diagnosis of dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DIMENSION analysis(D alpha,D sigma), cerebrospinal fluid biomarker(amyloid beta protein, phosphorylated tau protein), cerebral blood flow, Mini-Mental State Examination(MMSE), Hasegawa's Dementia Scale Revised(HDS-R), Alzheimer's Disease Assessment Scale (ADAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
The electroencephalography for 5 to 15 minutes, Collection of cerebrospinal fluid, SPECT, Neuropsychological test
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Alzheimer's disease, non-Alzheimer's disease neuropathy
(2)Patients who obtained informed consent.
Key exclusion criteria
Patients other than the above
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Urakami |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6354
kurakami@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Urakami |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6354
Homepage URL
kurakami@med.tottori-u.ac.jp
Sponsor or person
Institute
Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2014 | Year | 06 | Month | 11 | 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
| 2014 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 10 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016567
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| Registered date | File name |
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