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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035162
Receipt No. R000040075
Scientific Title Evaluation of the Aikomi system as a potential tool to reduce BPSD in people with mild to moderate dementia
Date of disclosure of the study information 2019/05/31
Last modified on 2019/06/07

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Basic information
Public title Evaluation of the Aikomi system as a potential tool to reduce BPSD in people with mild to moderate dementia
Acronym Evaluation of the Aikomi system as a potential tool to reduce BPSD in people with mild to moderate dementia
Scientific Title Evaluation of the Aikomi system as a potential tool to reduce BPSD in people with mild to moderate dementia
Scientific Title:Acronym Evaluation of the Aikomi system as a potential tool to reduce BPSD in people with mild to moderate dementia
Region
Japan

Condition
Condition Dementia
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the beneficial effects of the Aikomi system for manage BPSD in people with dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Caregiver rated changes in Behavioral and psychological symptoms in people with dementia during and after use of Aikomi system
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 BPSD amelioration system
Duration:1 day
Usage: one system per person
Frequency: about 30 minutes per day
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Subject is residing in nursing care facilities
2) Subject has received a disgnosis of Alzheimer type, Lewy bodies type, or cerebrovascular type dementia
3) Subject is exhibiting BPSD symptoms such as apathy or anxiety
4) Subject is 75 years or older at the time of obtaining informed consent
5) Informed consent has been obtained from the subject, their family member, or their representative
6) The Subject , family member, or representstive understands the content of research, and the subject is judged to be able to participate in the research by the nursing care facility in charge
7) Subject is a native Japanese speaker
8) The daily life independence level of the subject is within IIa to IIIb for elderly with dementia
Key exclusion criteria 1) Subject has psychiatric disorders other than BPSE symptoms defined by DSM-V
2) Subject shows amblyopia or has hearing loss
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Maeda
Middle name
Last name Kiyoshi
Organization Kobe Gakuin University
Division name Faculty of Comprehensive Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL 0789741551
Email maedak@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Junichi
Middle name
Last name Kato
Organization Aikomi Ltd.
Division name Aikomi Ltd.
Zip code 251-8555
Address 26-1 Muraoka-Higashi 2-chome Fujisawa, Kanagawa
TEL 07045382855
Homepage URL
Email junichi.kato@aikomi.co.jp

Sponsor
Institute Kobe Gakuin University, Faculty of Comprehensive Rehabilitation
Institute
Department

Funding Source
Organization Aikomi Ltd.
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 Kobe University Gakuin University Comprehensive Rehabilitation Faculty Research Ethics Review Committee
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe
Tel 0789742438
Email soureha@j.kobegakuin.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 05 Month 31 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
2019 Year 03 Month 30 Day
Date of IRB
2019 Year 03 Month 19 Day
Anticipated trial start date
2019 Year 03 Month 20 Day
Last follow-up date
2020 Year 03 Month 20 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 12 Month 06 Day
Last modified on
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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