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Clinical Trials/JPRN-jRCTs072230053
JPRN-jRCTs072230053
Recruiting
未知

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

agao Tetsuhiko0 sites40 target enrollmentAugust 25, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
dementia or mild cognitive impairment
Sponsor
agao Tetsuhiko
Enrollment
40
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 25, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
agao Tetsuhiko

Eligibility Criteria

Inclusion 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\-80 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.

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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