UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035162
Receipt number 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 2022/08/23 09:58:46

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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 Nicholas
Middle name William
Last name Hird

Organization

Aikomi Ltd.

Division name

Aikomi Ltd.

Zip code

2200012

Address

Level 19 Minato Mirai Center Building , 3-6-1, Minatomirai Nishi-ku Yokohamashi Kanawawa

TEL

07045382854

Homepage URL


Email

nick.hird@aikomi.co.jp


Sponsor or person

Institute

Kobe Gakuin University, Faculty of Comprehensive Rehabilitation

Institute

Department

Personal name



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

Completed

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

2022 Year 08 Month 23 Day



Link to view the page

Value
https://center6.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