Alzheimer's pathology and sleep disturbance: - AT-Sleep

Takano Harumasa0 sites50 target enrollmentDecember 29, 2022

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Takano Harumasa
Enrollment: 50
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 29, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Takano Harumasa

Eligibility Criteria

Inclusion Criteria

•1\. Alzheimer's dementia (AD) spectrum patients
•1\) Aged 60 years and above and 80 years and below at the time of obtaining consent. All of the sexes are included.
•2\) Being and outpatient or having a history of participation in research, and either A, B, or Cis applicable from among the following
•3\) Persons who can consent to participation of the study under their free will
•4\) Having a study partner who has contact with the participant at least once a week and who is willing to participate in this study as an information provider (in\-person, telephone, and email were accepted contact methods)
•5\) Vision, hearing ability, and writing ability are maintained to a degree that has no effect on cognitive tests
•6\) Having consented to undergo all examinations, including magnetic resonance imaging (MRI), positron emission tomography (PET), sleep\-related examinations such as polysomnography (PSG), and gene analysis
•a) Probable AD according to the National Institute on Aging and Alzheimer's Association (NIA\-AA) criteria
•b) Total Mini\-Mental State Examination (MMSE) scores equal to or less than 23
•c) Scores of 0\.5 or 1 in global clinical dementia scale (CDR)

Exclusion Criteria

•1\. AD spectrum
•1\) Having been diagnosed with a specific neurodegenerative disease other than AD, or proven to have multiple cerebral infarctions, normal pressure hydrocephalus, brain tumors, epilepsy, subdural hematoma, multiple sclerosis, or head trauma with residual symptoms or brain structural abnormalities
•2\) Exhibiting local lesions on MRI, such as infections and cerebral infarctions, which could affect cognitive function. Asymptomatic deep small infarctions and mild white matter changes are deemed acceptable for inclusion, but atheromal thrombosis and cardiac embolism, infarction with lesions in the cerebral cortex, or severe diffuse white matter changes (Fazekas grades equal to or above 3\) are excluded.
•3\) Possessing an implanted pacemaker, aneurysm clip, artificial inner ear, or other magnetic/electric conductive metals or being unable to undergo MRI because of claustrophobia
•4\) Having allergy to thioflavin derivatives
•5\) Having a history of major depressive disorder or bipolar disorder defined by Diagnostic Statistical Manual (DSM)\-V within 1 year prior or schizophrenia as defined by DSM\-5
•6\) Being comorbid with or having a history of alcohol/drug dependence as defined by DSM\-V within past 2 years
•7\) Exhibiting psychiatric symptoms, excitement, or behavioral disturbance to a degree that would have hindered their ability to follow the research protocol within the preceding three months
•8\) Having serious systemic diseases or unstable diseases
•9\) Residing in a nursing home or being hospitalized