UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018686 |
|---|---|
| Receipt number | R000021626 |
| Scientific Title | Effect measurement of dementia prevention program using NAT (Neuronal Activity Topography) analysis |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2022/08/10 12:05:29 |
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Basic information
Public title
Effect measurement of dementia prevention program using NAT (Neuronal Activity Topography) analysis
Acronym
Effect measurement of dementia prevention program using NAT analysis
Scientific Title
Effect measurement of dementia prevention program using NAT (Neuronal Activity Topography) analysis
Scientific Title:Acronym
Effect measurement of dementia prevention program using NAT analysis
Region
| Japan |
Condition
Condition
Mild cognitive impairment (MCI) and Mild dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of the effect of the interventions for the patients with mild cognitive impairment (MCI) and mild dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Neuronal activity measured using the electroencephalography (EEG) records, Alzheimer's Disease Assessment Scale(ADAS) after 5 months
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise, Music therapy, Cognitive training for 5 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mild cognitive impairment (MCI) and Mild dementia patients
Key exclusion criteria
not applicable
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Asada |
Organization
Memory Clinic Ochanomizu
Division name
Medical care Division
Zip code
Address
4F Ochanomizu Igakukaikan, 1-5-34, Yushima, Bunkyo-ku, Tokyo, 113-0034 JAPAN
TEL
03-6801-8718
asada@memory-cl.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mieko Tanaka |
Organization
Brain Functions Lab., Inc.
Division name
Research Division
Zip code
Address
1-502 Leading Venture Plaza, 75-1, Ono-cho, Tsurumi-ku, Yokohama 230-0046 JAPAN
TEL
050-3774-6162
Homepage URL
mtanaka@bfl.co.jp
Sponsor or person
Institute
Brain Functions Lab., Inc.
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency, RISTEX
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
オリーブクリニックお茶の水（東京都）Olive Clinic Ochanomizu (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 18 | 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
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021626
