UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042372 |
|---|---|
| Receipt number | R000048355 |
| Scientific Title | Comparison of frontal electroencephalogram during tasks and resting-state in Alzheimer's disease and mild cognitive impairment with healthy controls: a pilot study |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2021/11/09 09:55:34 |
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Basic information
Public title
Comparison of frontal electroencephalogram during tasks and resting-state in Alzheimer's disease and mild cognitive impairment with healthy controls: a pilot study
Acronym
Comparison of frontal electroencephalogram during tasks and resting-state in Alzheimer's disease and mild cognitive impairment with healthy controls: a pilot study
Scientific Title
Comparison of frontal electroencephalogram during tasks and resting-state in Alzheimer's disease and mild cognitive impairment with healthy controls: a pilot study
Scientific Title:Acronym
Comparison of frontal electroencephalogram during tasks and resting-state in Alzheimer's disease and mild cognitive impairment with healthy controls: a pilot study
Region
| Japan |
Condition
Condition
Alzheimer's disease, mild cognitive impairment
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Left and right frontal lobe electroencephalograms were measured using a simple bipolar electroencephalograph (EEG) system in patients with Alzheimer's disease (AD), mild cognitive impairment (MCI), and healthy subjects to examine the relationship between cognitive decline and EEG. In addition to biostatistical analysis, this study will attempt to evaluation the severity of disease using machine learning.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG
In particular, each frequency after the Fourier or Hilbert transforms and the amplitude variation of each frequency in the EEG during the measurement times will be involved.
Key secondary outcomes
Mini-Mental State Examination (MMSE)
Montreal Cognitive Assessment (MoCA-J)
Logical memory
Stroop test
Digit span test
Trail making test B
Word Fluency Test
Ray Auditory Verbal Learning Test
Rey -Osterrieth Complex Figure Test
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For Alzheimer's disease
1) Patients diagnosed with Alzheimer's disease according to the DSM-5 diagnostic criteria
2) Patients who have been judged by their doctors to have the capacity to make consent decisions and who have a full understanding of the study or who have received consent from a surrogate.
For MCI
1) Patients diagnosed with MCI according to DSM-5 diagnostic criteria
2) Patients who have been judged by their doctors to have the capacity to make consent decisions and who have a full understanding of the study or who have received consent from a surrogate
For healthy individuals
1) Healthy individuals with no history of mental illness who have volunteered to participate in the study through web advertisements, bulletin boards, email announcements, etc., or through their organizations
Key exclusion criteria
1) Patients with some kind of physical disease that would make it difficult to measure EEG with a simple bipolar electroencephalography system (e.g., frontal skin disease or skull defect)
2) Patients with neurological or physical diseases that can affect EEG (e.g., brain tumor, stroke, epilepsy, disturbance of consciousness)
3) Patients receiving treatments that are likely to have a significant effect on EEG results (e.g., antiepileptic medication)
4) A person suffering from a mental illness other than dementia
5) When the principal investigator or sub-investigator decides that it is inappropriate to conduct
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Taishiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3492
tkishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Horigome |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3492
Homepage URL
toshiro@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
KGRI-IoT
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University, Faculty of Science and Technology
Asaka Hospital
Shonan Keiiku Hospital
Tsutsuji Mental Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University, Life Science Medical Ethics Monitoring Committee Office
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3611
med-bemoc-office@adst.keio.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
あさかホスピタル(福島県)
湘南慶育病院(神奈川県)
つつじメンタルホスピタル(群馬県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe EEG data and cognitive function data.
Management information
Registered date
| 2020 | Year | 11 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048355
