The goal of this clinical trial is to explore and verify the preventive effects of melatonin on the progression of Alzheimer's disease. The study aims to analyze the changes in blood biomarkers (phosphorylated tau, glial fibrillary acidic protein, neurofilament chain), various sleep-related subjective report questionnaire scores, physical performance, cognitive function scores and cerebellar volume change after three months of melatonin administration in patients with Alzheimer's-type mild cognitive impairment (MCI) accompanied by insomnia. The main questions it aims to answer are: 1. Does melatonin administration alter the levels of blood biomarkers associated with Alzheimer's disease? 2. What changes occur in sleep-related subjective report questionnaire scores and cognitive function scores following melatonin administration? 3. Does melatonin administration effect on physical performance? 4. Is there any relations between cognitive decline, phsycal performance and cerebellar volume change? We will compare the data collected before and after melatonin administration to determine its preventive effects on Alzheimer's disease progression. Participants Will: 1. Take melatonin every day for 3 months and Complete sleep-related subjective report questionnaires, neuropsychological assessments and physical performance test 2. Visit the clinic at the initial visit and after 3 months for checkups and tests. 3. Complete sleep-related subjective report questionnaires and neuropsychological assessments and physical performance test 4. Provide blood samples for biomarker analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
3months melatonin
15minutes of sleep hygiene education on the first day of visiting the hospital
Change in Serum p-Tau 217 Levels from Baseline to Week 12
Serum p-Tau 217 levels will be measured at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in concentration (pg/mL) between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Serum Glial Fibrillary Acidic Protein (GFAP) Levels from Baseline to Week 12
Serum GFAP levels will be measured at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in concentration (pg/mL) between baseline and Week 12
Time frame: Baseline and Week 12
Change in Serum Neurofilament Light Chain (NfL) Levels from Baseline to Week 12
Serum Neurofilament Light Chain (NfL) levels will be measured at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in concentration (pg/mL) between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Physical Performance from Baseline to Week 12
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which evaluates balance, gait speed, and lower body strength. Changes will be reported as differences in total SPPB scores(points) between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Global Deterioration Scale (GDS) Scores from Baseline to Week 12
Global Deterioration Scale (GDS) scores will be assessed as a measure of cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Clinical Dementia Rating (CDR) Scores from Baseline to Week 12
Clinical Dementia Rating (CDR) scores will be assessed as a measure of cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Verbal Fluency Scores from Baseline to Week 12
Verbal fluency(points), assessed as a subtest of the CERAD-K battery, will be used to measure cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Mini-Mental State Examination (MMSE) Scores from Baseline to Week 12
The Mini-Mental State Examination (MMSE)(points), assessed as a subtest of the CERAD-K battery, will be used to measure cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Boston Naming Test (BNT) Scores from Baseline to Week 12
The Boston Naming Test (BNT)(points), assessed as a subtest of the CERAD-K battery, will be used to evaluate cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Word List Recall Scores from Baseline to Week 12
Word List Recall(points), assessed as a subtest of the CERAD-K battery, will be used to evaluate cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Word List Recognition Scores from Baseline to Week 12
Word List Recognition(points), assessed as a subtest of the CERAD-K battery, will be used to evaluate cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Constructional recall from Baseline to Week 12
Constructional recall(points), assessed as a subtest of the CERAD-K battery, will be used to evaluate cognitive function at baseline and at the end of the 12-week treatment period. Changes will be reported as the difference in scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Pittsburgh Sleep Quality Index (PSQI) Global Scores from Baseline to Week 12
The Pittsburgh Sleep Quality Index (PSQI) global score will be used to assess sleep quality. A global score greater than 5 indicates significant sleep disturbances, with higher scores representing greater levels of sleep disturbance. Changes will be reported as the difference in PSQI global scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Insomnia Severity Index (ISI) Scores from Baseline to Week 12
The Insomnia Severity Index (ISI) is a brief, self-rated scale consisting of seven items scored on a 0-4 scale, used to measure the severity of insomnia.Scores of 15 or higher indicate moderate to severe insomnia. Changes will be reported as the difference in ISI scores between baseline and Week 12.
Time frame: Baseline and Week 12
Change in Epworth Sleepiness Scale (ESS) Scores from Baseline to Week 12
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire consisting of eight items designed to measure daytime sleepiness in daily life. Scores above 10 indicate clinically meaningful daytime sleepiness, with higher scores reflecting greater severity. Changes will be reported as the difference in ESS scores between baseline and Week 12.
Time frame: Baseline and Week 12
Differences in Cerebellum Volume and Its Correlation with Blood Biomarkers, Physical Performance, Cognitive Tests, and Sleep Questionnaire Responses
The study will assess cerebellum volume at the time of enrollment and analyze its correlations with blood biomarker levels (p-Tau 217, NfL), physical performance metrics, cognitive test scores, and sleep-related questionnaire responses. Correlations will be reported using Spearman's correlation coefficients.
Time frame: At the time of enrollment
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