UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047077 |
|---|---|
| Receipt number | R000053475 |
| Scientific Title | A retrospective observational study of a novel smartphone App on the management of patients with mild cognitive impairment or mild dementia |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2023/03/05 18:41:01 |
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Basic information
Public title
A retrospective observational study of a novel smartphone App on the management of patients with mild cognitive impairment or mild dementia
Acronym
A observational study of a novel smartphone App on patients with mild cognitive impairment or mild dementia
Scientific Title
A retrospective observational study of a novel smartphone App on the management of patients with mild cognitive impairment or mild dementia
Scientific Title:Acronym
A observational study of a novel smartphone App on patients with mild cognitive impairment or mild dementia
Region
| Japan |
Condition
Condition
Mild cognitive impairment/Mild dementia
Classification by specialty
| Medicine in general | Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to conduct a retrospective observational study in patients with mild cognitive impairment/mild dementia using the LQ-M/D application to investigate the safety and efficacy of the application.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Mini Mental State Examination (MMSE) scores before and after using the LQ-M/D application
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women who are between 40 and 90 years old at the time of the application start
2. Diagnosed with MCI or dementia according to DSM-5
3. MMSE score of 20 or higher and CDR score of 0 to 1
4. Performance status of 0
Key exclusion criteria
1. Patients who do not wish to participate in this study by opting out
2. Using other health care applications for health promotion purposes
3. Enrolled in other clinical trials (unless they are enrolled only in observational studies without therapeutic intervention)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Horie |
Organization
Graduate School of Medicine, Faculty of Medicine, Juntendo University
Division name
Department of Digital Therapeutics
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1021
shorie@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Reo |
| Middle name | |
| Last name | Hamaguchi |
Organization
Graduate School of Medicine, Faculty of Medicine, Juntendo University
Division name
Department of Digital Therapeutics
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1021
Homepage URL
r.hamaguchi.ea@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Life Quest Inc.
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
Ethics Committee of the Faculty of Medicine, Juntendo University, Japan
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1021
igakubu.rinri1@juntendo.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
| 2022 | Year | 03 | Month | 04 | 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
20
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
| 2022 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study of patients who used a smartphone application to maintain and improve cognitive function for mild cognitive impairment/mild dementia.
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053475
