UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035926 |
|---|---|
| Receipt number | R000040217 |
| 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) |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2022/04/06 12:52:07 |
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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
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
dbnn@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Behavioral Neurology and Neuropsychiatry, Osaka University United Graduate School of Child Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040217
