UMIN-CTR Clinical Trial

Basic information
Public title	Cognitive training via conversation support to healthy older adults-1
Acronym	Cognitive training via conversation support to healthy older adults-1
Scientific Title	Cognitive training via conversation support to healthy older adults-1
Scientific Title:Acronym	Cognitive training via conversation support to healthy older adults-1
Region	Japan

Condition
Condition	Healthy older adults
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study`s purpose is to gather evidence on the effect of a group conversation intervention on cognition in healthy older adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Cognitive function -Montreal Cognitive Assessment (MOCA) -Mini Mental State Examination (MMSE) -WMS-R, Logical memory I,II -Advanced Trail Making Test (ATMT) -Digit span -Digit symbol -Verbal fluency Evaluation Before intervention and after intervention (12 weeks) (2) Brain Imaging -MRI -fMRI -DTI Evaluation After intervention
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group participants receive weekly 30-minute intervention sessions, each followed by 30 minutes of explanation about intervention.
Interventions/Control_2	The active control sessions in the control group involved 30 minutes of weekly unstructured conversation among the group and 30 minutes of health education about successful aging.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)>=65 years old (2)MMSE>=24 (3)Can complete evaluations and interventions (4)Agree to participate
Key exclusion criteria	(1)Having any neurological impairment known to affect the central nervous system (2)Having any serious complicating disorder (3)Having any history of serious head injury (4)Having any disease or medication known to affect the central nervous system
Target sample size	65

Research contact person
Name of lead principal investigator	1st name Mihoko Middle name Last name Otake-Matsuura
Organization	RIKEN
Division name	Center for Advanced Intelligence Project
Zip code	103-0027
Address	Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL	0362252482
Email	mihoko.otake@riken.jp

Public contact
Name of contact person	1st name Mihoko Middle name Last name Otake-Matsuura
Organization	RIKEN
Division name	Center for Advanced Intelligence Project
Zip code	103-0027
Address	Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL	0362252482
Homepage URL
Email	mihoko.otake@riken.jp

Sponsor
Institute	The RIKEN Center for Advanced Intelligence Project
Institute
Department

Funding Source
Organization	The RIKEN Center for Advanced Intelligence Project
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	RIKEN, Bio Safety and Ethics Section
Address	2-1, Hirosawa, Wako, Saitama, Japan
Tel	048-467-9293
Email	mizuho.mamiya@riken.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	2019 Year 05 Month 08 Day

Related information
URL releasing protocol	https://www.frontiersin.org/articles/10.3389/frobt.2021.633076/full
Publication of results	Published

Result
URL related to results and publications	https://www.frontiersin.org/articles/10.3389/frobt.2021.633076/full
Number of participants that the trial has enrolled	65
Results	Among the primary outcome measures, one of the subcategories of cognitive functions, verbal fluency significantly improved in the intervention group. Among the process outcome measures, a part of the subcategories of linguistic characteristics of speech, the amount of speech and richness of words, proportion of providing topics, questions, and answers in total utterances were larger for the intervention group.
Results date posted	2021 Year 04 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The participants were community-living healthy adults aged over 65 years, recruited from the Silver Human Resources Center.
Participant flow	The intervention was provided once a week for 12 weeks.
Adverse events	None
Outcome measures	Primary outcome measures were the cognitive functions; process outcome measures included the linguistic characteristics of speech to estimate interaction quality.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 01 Day
Date of IRB	2018 Year 06 Month 04 Day
Anticipated trial start date	2018 Year 06 Month 04 Day
Last follow-up date	2018 Year 11 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	2019 Year 05 Month 07 Day
Last modified on	2021 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041775