UMIN-CTR Clinical Trial

Basic information
Public title	Intervention and Biomarker for Mild Cognitive Impairment
Acronym	IBMCI
Scientific Title	Intervention and Biomarker for Mild Cognitive Impairment
Scientific Title:Acronym	IBMCI
Region	Japan

Condition
Condition	Mild Cognitive Impairment
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	In this study, an effective intervention approach for the progression of elderly with high dementia risk and exploratory study of useful biomarkers correlated with cognitive function are conducted.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	logical memory II after 6 months intervention
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Synapsology 6 months ( 2 times/week, 30 min/time)
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	65 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	MMSE (Mni-mental state examination) >= 22 CDR (Clinical Dementia Rating) = 0.5 Logical memory II <= -1SD adjusted by education year GDS (Geriatric Depression Scale) <= 6 Participant's own consent
Key exclusion criteria	History of dementia History of neurological/psychiatric disease Severe visual or auditory impairment Serious complications MRI can not shoot People can not stand quietly by resting for about 1 hour.
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Shuhei Middle name Last name Yamaguchi
Organization	Shimane University
Division name	Department of Neurology, Faculty of Medicine
Zip code	693-8501
Address	89-1, Enyacho, Izumo, Shimane
TEL	0853-20-2198
Email	yamagu3n@med.shimane-u.ac.jp

Public contact
1st name of contact person	1st name Onoda Middle name Last name Keiichi
Organization	Shimane University
Division name	Department of Neurology, Faculty of Medicine
Zip code	693-8501
Address	89-1, Enyacho, Izumo, Shimane
TEL	0853-20-2198
Homepage URL
Email	onodak1@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	SHIMAZU Medical Care Service ERISA
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	The Shimane University Institutional Committee on Ethics
Address	Enyacho, 89-1, Izumo, Shimane
Tel	0853-20-2515
Email	kenkyu@med.shimane-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	2018 Year 12 Month 01 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	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 10 Day
Date of IRB	2018 Year 11 Month 05 Day
Anticipated trial start date	2018 Year 11 Month 10 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 29 Day
Last modified on	2019 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039534