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Clinical Trials/jRCT1031220550
jRCT1031220550RecruitingNot Applicable

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

APRINOIA Therapeutics0 sites50 target enrollmentStarted: January 5, 2023Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Primary Endpoint
Reduction in the ratio of deep sleep (N3 sleep)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
60age old over to 80age old under (—)
Sex
All

Inclusion Criteria

  • •Alzheimer's dementia (AD) spectrum patients
  • •Aged 60 years and above and 80 years and below at the time of obtaining consent. All of the sexes are included.
  • •Being and outpatient or having a history of participation in research, and either A, B, or Cis applicable from among the following
  • •Persons who can consent to participation of the study under their free will
  • •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)
  • •Vision, hearing ability, and writing ability are maintained to a degree that has no effect on cognitive tests
  • •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)
  • •B. Mild cognitive impairment (MCI) due to AD
  • •a) MCI due to AD according to the NIA-AA criteria
  • •b) Total MMSE scores equal to or less than 27
  • •c) Scores of 0.5 in global CDR and 0.5 or 1 in the memory domain
  • •C. Preclinical AD
  • •a) Preclinical AD according to the criteria of NIA-AA (amyloid-positive in a previous amyloid PET or cerebrospinal fluid study)
  • •b) Total MMSE scores equal to or more than 28
  • •c) Score of 0 in global CDR
  • •Healthy volunteers
  • •Healthy individuals with normal cognitive function (MMSE scores equal to or above 28)
  • •Aged 60-80 years. Any sex is included.
  • •Score of 0 in global CDR
  • •Consent to undergo all examinations, that is, MRI, PET, sleep-related examinations such as PSG, and gene analysis
  • •Giving informed consent based on participant's free will after the participant understand the content of the study

Exclusion Criteria

  • •AD spectrum
  • •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
  • •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.
  • •Possessing an implanted pacemaker, aneurysm clip, artificial inner ear, or other magnetic/electric conductive metals or being unable to undergo MRI because of claustrophobia
  • •Having allergy to thioflavin derivatives
  • •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
  • •Being comorbid with or having a history of alcohol/drug dependence as defined by DSM-V within past 2 years
  • •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
  • •Having serious systemic diseases or unstable diseases
  • •Residing in a nursing home or being hospitalized
  • •Currently participating in a clinical interventional study/trial or a history of having participated in anti-amyloid trials
  • •Other, when a patient is judged as unsuitable by the principal investigator or sub-principal investigator
  • •Healthy volunteers
  • •Being diagnosed with a specific neurodegenerative disease including the AD spectrum. Proven to have multiple cerebral infarctions, normal pressure hydrocephalus, epilepsy, subdural hematoma, multiple sclerosis, and head trauma, with residual symptoms or brain structural abnormalities.
  • •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.
  • •Possessing an implanted pacemaker, aneurysm clip, artificial inner ear, or other magnetic/electric conductive metals or being unable to undergo MRI because of claustrophobia
  • •Having allergy to thioflavin derivatives
  • •Having a history of major depressive disorder or bipolar disorder as defined by DSM-V within 1 year prior or schizophrenia as defined by DSM-5
  • •Being co-morbid with or having a history of alcohol/drug dependence as defined by DSM-V within 2 years prior
  • •Being under treatment for a sleep disorder
  • •Having serious systemic diseases or unstable diseases
  • •Others, judged to be unsuitable by principal investigator (PI) and co-PI.

Outcomes

Primary Outcomes

Reduction in the ratio of deep sleep (N3 sleep)

Associations between amyloid/tau pathology and reduction in the ratio of deep sleep (N3 sleep)

Reduction in the period and quantity of total sleep

Associations between amyloid/tau pathology and reduction in the period and quantity of total sleep

Secondary Outcomes

  • Discrepancies in subjective sleep and objective sleep indices
  • Self-evaluation of sleep
  • PSG variables
  • PSG sleep stage variables
  • Actigraphy
  • Associations between brain atrophy on MRI and sleep variables
  • Associations between APOE epsilon 4 allele and sleep variables

Investigators

Sponsor
APRINOIA Therapeutics

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Alzheimer's pathology and sleep... | Clinical Trial