UMIN-CTR Clinical Trial

Basic information
Public title	An investigator-initiated clinical research on the ability of an electroencephalogram analysis program to differentiate between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD)
Acronym	An investigator-initiated clinical research on the ability of an electroencephalogram analysis program to differentiate between DLB and AD
Scientific Title	An investigator-initiated clinical research on the ability of an electroencephalogram analysis program to differentiate between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD)
Scientific Title:Acronym	An investigator-initiated clinical research on the ability of an electroencephalogram analysis program to differentiate between DLB and AD
Region	Japan

Condition
Condition	dementia with Lewy bodies (DLB) , Alzheimer's disease (AD)
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this research is to determine how accurately the electroencephalogram (EEG) analysis program can identify subjects with probable DLB among subjects including those with probable AD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of the EEG analysis program in identifying subjects with a diagnosis of probable DLB and subjects with a diagnosis of probable AD (on the basis of the clinical diagnostic criteria)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Standardized EEG recording will be acquired and analyzed with the EEG analysis program.
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	50 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1)50-90 years of age, inclusive. 2)Patients with DLB, if applicable, who are identified as suffering from probable DLB according to the revised consensus criteria.Patients with AD, if applicable, who are identified as suffering from probable AD according to the NIAAA criteria, except for patients with probable AD who meet the criteria for possible DLB. To confirm this, the subject must have undergone sufficient clinical evaluation. 3)Mini Mental State Examination score between 14 to 26. 4)Results available from MRI or CT scan performed within 12 months prior to the screening visit to rule out possible vascular dementia. 5)Subject or responsible caregiver provides informed consent for the subject to participate in the research.
Key exclusion criteria	1)Subject or responsible caregiver is unable or unwilling to give informed consent. 2)Presence of local or diffuse vascular lesions on MRI or CT, where this is thought to be the cause of, or contribute to the severity of the subject's dementia. 3)Suffering from a significant neurologic disease other than probable DLB or AD. 4)Systemic diseases possibly contributing to the severity of dementia. 5)History of alcohol or drug abuse or dependence within the past 2 years. 6)History of schizophrenia. 7)Any significant systemic illness or unstable medical condition that may affect EEG. 8)Use of specific medications: a)Centrally active beta-blockers (propranolol), methyldopa and clonidine within 4 weeks prior to screening, narcotics. b)Use of anti-Parkinsonism medications other than levodopacarbidopa, or levodopa benserazide within 4 weeks prior to screening. c)Neuroleptics or narcotic analgesics within 4 weeks prior to screening d)Long acting benzodiazepines or barbiturates within 4 weeks prior to screening e)Use of short-acting anxiolytics or sedative hypnotics more than 2 times per week within 4 weeks prior to screening. 9)Patients currently using memantine. Cholinesterase inhibitors are permitted if doses are stable for 4 weeks prior to screening. 10)Use of any investigational drugs within 30 days or 5 half lives prior to screening. 11)Subjects who, in the Principal Investigator's opinion, are unlikely to comply with the EEG recording procedure.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Etsuro Middle name Last name Mori
Organization	Osaka University United Graduate School of Child Development
Division name	Department of Behavioral Neurology and Neuropsychiatry
Zip code	565-0871
Address	2-2, Yamadaoka, Suita Osaka
TEL	06-6879-3373
Email	dbnn@psy.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Etsuro Middle name Last name Mori
Organization	Osaka University United Graduate School of Child Development
Division name	Department of Behavioral Neurology and Neuropsychiatry
Zip code	565-0871
Address	2-2, Yamadaoka, Suita Osaka
TEL	06-6879-3373
Homepage URL
Email	dbnn@psy.med.osaka-u.ac.jp

Sponsor
Institute	Department of Behavioral Neurology and Neuropsychiatry, Osaka University United Graduate School of Child Development
Institute
Department

Funding Source
Organization	Mentis Cura AS
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-u.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

Other administrative information
Date of disclosure of the study information	2019 Year 03 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	Main results already published
Date of protocol fixation	2019 Year 02 Month 13 Day
Date of IRB	2019 Year 03 Month 08 Day
Anticipated trial start date	2019 Year 04 Month 10 Day
Last follow-up date	2019 Year 12 Month 04 Day
Date of closure to data entry	2019 Year 12 Month 06 Day
Date trial data considered complete	2020 Year 01 Month 09 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 19 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040217