The primary outcome measure is K-MMSE score changes at the endpoint. The secondary outcome measures include demographic data, baseline and follow-up SNSB subdomain scores, self-report questionnaires, HCT scores, brain MRI markers, florbetaben PET positivity, quantitative regional amyloid depositions using PET scans, and clinical progression rates.
All participants will undergo baseline neurologic examinations, neuropsychological tests named SNSB, brain MRIs, blood labs, and florbetaben PET scans for amyloid depositions. PET findings are interpreted using a visual rating scale named brain amyloid plaque load and rated as positive amyloidosis with a brain amyloid plaque load score of 2/3.[9 (link)] Quantitative neuroimaging analysis will be performed.
At baseline, questionnaires for SCD, amyloid PET scans, brain MRIs including 3 dimensional-T1 imaging, plasma amyloid beta values are examined. Telephone-based HCT at home are performed every 6 months during the study period. Annual follow-up evaluations include detailed neuropsychological tests, physical and neurologic examinations, and physician’s assessments for clinical progression. Brain MRI and plasma amyloid beta values are assessed at baseline and 24 months later (Table 1).
Clinical progression to mild cognitive impairment or dementia will be assessed at the final visit. The cognitive tests were administered by a trained neuropsychologist. Participants with CDR score ≥ 0.5 or Korean version of activities of daily living score ≥ 0.43 were considered to have progressed to MCI or dementia.
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