UMIN-CTR Clinical Trial

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
Email	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
Email	kurakami@med.tottori-u.ac.jp

Sponsor
Institute	Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016567