Exploratory clinical research to determine the efficacy and safety of disease treatment programs for research subjects with dementia or mild cognitive impairment

JRCT ID: jRCTs072230053

Registered date:25/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: dementia or mild cognitive impairment
• Date of first enrollment: 19/02/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Overall clinical evaluation, etc. during a 6-month period when the research device (medical device app/sham app) is used will be performed. After confirming eligibility through a pre-screening test, the intervention using the research device will begin from the time of enrollment onward. The observation period will be 6 months (26 weeks), during which the research subjects will perform the exercises instructed by the research device and record their daily activities. During this period, the subjects will visit the hospital at 4 weeks, 12 weeks, 26 weeks, or discontinuation of the use of the research equipment to confirm the continuation of the exercise therapy, provide feedback on the evaluation, and confirm that they are physically fit to continue the exercise therapy, using the said application, and to confirm the feeling of using the research equipment.

Outcome(s)

Primary Outcome

Changes in the following scales over a 6-month period (26 weeks)
1) Clinical Dementia Rating - Sum of Boxes (CDR- SB)(General Clinical Assessment)

Secondary Outcome

Changes in the following scales at the 26-week time point (some scales may have separate implementation dates)
1.ADAS-Cog
2.EQ-5D-5L
3.The following tests to evaluate physical ability and walking ability, etc.
(a)Grip strength
(b)TUG test (timed up & go test)
(c)2-step test

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

The study requires the participation of the study partner of the research subject (a person who can be contacted by the research subject at least twice a week and who does not have to be a blood relative). However, as described in (1) 2) below, a person in charge at the facility may participate in place of the study partner.

(1) Research subjects
The study subjects will be those who meet all of the following criteria
1) Male and female patients aged 60-85 years at the time consent is obtained.
2) The research subjects must have a study partner. However, if no such person is available, a substitute, contactable person may be determined at the facility.
3) Patients with MMSE scores between 21 and 27.
4) Patients must have the literacy, vision, and hearing to be able to perform the CDR test and other neuropsychological tests.
5) Patients who have an appropriate informant for the CDR and other neuropsychological tests and who is able to come to the hospital when these tests are performed. The study partner may also serve concurrently as long as the study partner is able to provide appropriate information.
6) Patients who have given their free and voluntary written consent to participate in this study. However, in the case of patients with a MMSE score of 23 or less on the pre-screening test, consent shall be obtained from both the study subject and a surrogate (legal representative or close relative who is a family member of the study subject). The study partner may serve as that surrogate.
7) Patients who use a smart phone (iPhone) on a daily basis, or who, if loaned an iPhone, have the will and ability to use said iPhone on a daily basis.
8) The patient agrees not to participate in any other interventional clinical study or clinical trial during this study.

(2) Study Partner
1) iPhone or Android smartphones (limited to models eligible for the device program) ) who uses the device on a daily basis.
2) A person who is able to accompany the research subject to the hospital and can be contacted by phone at the designated time.

Exclude criteria

1) Patients who are inappropriate to undergo CT/MRI examination.
CT scan: Patients with a cardiac pacemaker/unremovable metal device are considered inappropriate for a CT scan. However, it may be performed only with the physician's permission.
MRI scan: Cardiac pacemakers, nerve stimulators, artificial eyes (movable by magnet), cochlear implants, inferior vena cava filters, shunt tubes (shunts for hydrocephalus), stents, etc. (refers to stents, plates, bolts, implants and bridges. The same applies hereinafter). (a stent, plate, bolt, implant, bridge, etc.; the same shall apply hereinafter), the patient shall be considered inappropriate for an MRI examination. However, since stents, etc. depend on the location of the stent, they may be used only with the physician's permission. On the other hand, in the case of tattoos, etc., the physician's judgment shall be used.
2) Patients who, at the time of consent, have a habit of exercising at an intensity of [breath-holding level or higher/150 minutes or more/week].
3) Patients who do not intend to make exercise a habit, or who do not have an environment in which they can incorporate exercise into their daily lives.
4) Patients with cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, etc., or intracranial or cerebrovascular malformation, which are currently recognized by CT/MRI examination, and who are judged to be unsuitable for the implementation of the reference behavior.
5) Patients with any of the following diseases/disabilities who are restricted from exercise or who are judged to be unsuitable to perform the reference behavior.
1) Serious cardiovascular disorders such as myocardial infarction or severe hypertension or diabetes mellitus
2) Respiratory disease such as chronic obstructive respiratory disease
3) Orthopedic problems such as bone and joint diseases
4) Dialysis therapy
5) Other diseases or disorders that may affect the ability to complete exercise therapy in this study
6) Patients previously diagnosed with arrhythmia (tachyarrhythmia, bradyarrhythmia, atrial fibrillation, etc.) who are deemed unfit to perform the reference actions.
7) Patients with any of the following psychiatric disorders.
1) Schizophrenia, depression, bipolar disorder, epilepsy. However, depression should be defined as a Geriatric Depression Scale (GDS) score of 8 or higher.
2) Other diseases or disorders that may affect the ability to complete this study.
8) Patients taking medications that affect pulse including the following
1) Beta-blockers
2) Calcium channel blockers (verapamil, diltiazem)
3) Antiarrhythmic drugs
9) Other patients who are deemed inappropriate to participate in this study by the principal investigator (subinvestigator).

Related Information

• Primary Sponsor: Nagao Tetsuhiko
• Secondary Sponsor: CogSmart Co., Ltd.