UMIN-CTR Clinical Trial

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
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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
Email	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
Email	toshiro@keio.jp

Sponsor
Institute	Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department

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
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
Email	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)

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
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	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	2020 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048355

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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