UMIN-CTR Clinical Trial

Basic information
Public title	Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Acronym	Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Scientific Title	Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Scientific Title:Acronym	Developing a neurocognitive brain health programs to improve and strengthen cognitive abilities in elderly people.
Region	Japan

Condition
Condition	Mild cognitive impairment
Classification by specialty	Medicine in general Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is developing a brain health programs to improve and strengthen cognitive abilities in elderly people via physical exercise and cognitive training, or using artificial intelligence-based robot for facilitating communication activities.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MMSE cognitive score after three-month interventions
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention: Facilitate communication activities using artificial intelligence-based robot (once every two weeks, six times in total (three months)) Control: no intervention
Interventions/Control_2	Physical exercise with cognitive training (no control group)
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly people with or at a risk of developing mild cognitive impairment with the MMSE cognitive score of 16-28/30.
Key exclusion criteria	People with abnormalities in hearing, vision, or motor functions.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shuko Middle name Last name Takeda
Organization	Osaka University School of Medicine
Division name	Clinical Gene Therapy
Zip code	565-0871
Address	2-2 Yamadaoka, Suita city, Osaka
TEL	0662108351
Email	takeda@cgt.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Shuko Middle name Last name Takeda
Organization	Osaka university School of Medicine
Division name	Clinical Gene Therapy
Zip code	565-0871
Address	2-2 Yamadaoka, Suita city, Osaka
TEL	0662108351
Homepage URL
Email	takeda@cgt.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Osaka Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Hospital
Address	2-2 Yamadaoka, Suita city, Osaka, 565-0871
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-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	2019 Year 07 Month 16 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	Preinitiation
Date of protocol fixation	2019 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 22 Day
Last follow-up date	2024 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	2019 Year 07 Month 16 Day
Last modified on	2019 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042623