UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development research of Tottori-method dementia prevention program
Title of the study (Brief title)	Development research of Tottori-method dementia prevention program
Region	Japan

Condition
Condition	Community residents who are suspected of cognitive decline
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate whether dementia prevention program combining exercise, intellectual activity and lecture about dementia can improve the cognitive function in subjects who are suspected of cognitive decline.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The results of Touch Panel-type Dementia Assessment Scale (TDAS) after six months.
Key secondary outcomes	The results of physical function-related evaluation, lifestyle disease-related evaluation and MRI after six months.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	First, dementia prevention program combining exercise, intellectual activity and classroom learning is performed once a week for 120 minutes a day for total of six months. After the intervention, we follow up without intervention for six months.
Interventions/Control_2	We observe without intervention during the first six months. Thereafter, dementia prevention program combining exercise, intellectual activity and classroom learning is performed once a week for 120 minutes a day for total of six months.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects who scored 10-13 points by simple computerized screening test (MSP; NIHON KOHDEN Corp, Tokyo, Japan) which was performed from April 1, 2016 to July 31, 2017 in Houki town. 2) Subjects who has already been diagnosed with dementia requires the consent from proxies.
Key exclusion criteria	1) Subjects who have a serious heart disease and are difficult to perform physical activity. 2) Subjects who cannot rise from sitting position at all. 3) If consent of MRI is obtained, subjects who have instruments and/or magnetic metals in the body. 4) Subjects who are assessed by the principal investigator due to other reasons.
Target sample size	300

Research contact person
Name of lead principal investigator	Katsuya Urakami
Organization	School of Health Science, Faculty of Medicine, Tottori University
Division name	Department of Biological Regulation
Address	86 Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6354
Email	kurakami@med.tottori-u.ac.jp

Public contact
Name of contact person	Minoru Kouzuki
Organization	School of Health Science, Faculty of Medicine, Tottori University
Division name	Department of Biological Regulation
Address	86 Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6358
Homepage URL
Email	kouzuki@med.tottori-u.ac.jp

Sponsor
Institute	Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization	The Nippon Foundation and Tottori prefecture
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 06 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Our results suggest that dementia prevention program combining exercise, intellectual activity and lecture about dementia is beneficial for improving the cognitive function and physical function in subjects who are suspected of cognitive decline.
Other related information

Management information
Registered date	2017 Year 06 Month 16 Day
Last modified on	2019 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031849