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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018686
Receipt No. 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 2016/05/04

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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
Email 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
Email mtanaka@bfl.co.jp

Sponsor
Institute Brain Functions Lab., Inc.
Institute
Department

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
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 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
2016 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021626

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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