UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Cognitive Training on the patients' white matter with mild cognitive impairment evaluated by brain imaging analysis
Acronym	Effectiveness of cognitive training by brain MR diffusion imaging
Scientific Title	Effectiveness of Cognitive Training on the patients' white matter with mild cognitive impairment evaluated by brain imaging analysis
Scientific Title:Acronym	Effectiveness of cognitive training by brain MR diffusion imaging
Region	Japan

Condition
Condition	Mild cognitive impairement
Classification by specialty	Neurology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the usefulness of home-based cognitive training using diffusion MRI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Neuropsychological tests before and after brain training for 12 weeks
Key secondary outcomes	Diffusion MRI before and after brain training for 12 weeks

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	Treatment
Type of intervention	Other
Interventions/Control_1	home-based brain training which includes dual task, reading and writing for 12 weeks.3 times a week Each session is 1 hour.
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. Patients who have subjective and objective memory impairments. 2. Patients who scored from 23 to 26 on MMSE. 3. Outpatients 4. Patients who live with family members or others
Key exclusion criteria	1. Patients with alcoholics 2. Patients with epilepsy 3. patients whose educational history is less than 6 years.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yumiko Middle name Last name Motoi
Organization	Juntendo University School of Medicine
Division name	Department of Diagnosis, Prevention and Treatment of Dementia
Zip code	1130033
Address	Hongo 2-1-1 Bunkyo-ku Tokyo
TEL	03-3813-3111
Email	motoi@juntendo.ac.jp

Public contact
Name of contact person	1st name Yumiko Middle name Last name Motoi
Organization	Juntendo University School of Medicine
Division name	Department of Diagnosis, Prevention, and Treatment of Dementia
Zip code	1130033
Address	Hongo 2-1-1 Bunkyo-ku Tokyo
TEL	03-3813-3111
Homepage URL
Email	motoi@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	Juntendo University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo University School of Medicine
Address	Hongo 2-1-1 Bunkyo ku Tokyo
Tel	0338133111
Email	motoi@juntendo.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 03 Month 31 Day

Related information
URL releasing protocol	https://www.abstractsonline.com/pp8/#!/7883/presentations/MCI,%20Hattori,%20Motoi,%20cognitive%20tra
Publication of results	Unpublished

Result
URL related to results and publications	https://www.abstractsonline.com/pp8/#!/7883/presentations/MCI,%20Hattori,%20Motoi,%20cognitive%20tra
Number of participants that the trial has enrolled	17
Results	The scores of digit span and Logical Memory I were significantly improved . The cortical thicknesses of the left supplementary motor area(SMA), the left superior frontal gyrus (L-SFG), frontal pole (FP) and orbitofrontal cortex(OFC) were negatively correlated with the score of digit span total points (DS), forward (DSF) and backward (DSB).
Results date posted	2020 Year 02 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	MCI patients The average age is 78.65 years old, the years of education on average is 12.53 years.
Participant flow	patients with MCI were instructed to perform training exercises three times per week for 12 weeks at home accompanied with their caretakers. The training includes two-digit number calculation, reading a short original story, fill-in-the blank tasks, simple calculations and dual task training. The caretakers measured the time spent in all tasks, and they took around 40 minutes on average. MRI and 13 neuropsychological tests were undertaken before and after the training.
Adverse events	None
Outcome measures	# the alteration in surface-based morphometry (SBM) # neuropsychological tests
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 31 Day
Date of IRB	2018 Year 03 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 31 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 04 Month 01 Day
Date trial data considered complete	2021 Year 04 Month 01 Day
Date analysis concluded	2021 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 31 Day
Last modified on	2021 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036553