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.
Male and female participants aged 60 to 90 years
Individuals presenting with cognitive impairment as their chief complaint at the Department of Psychiatry, St. Vincent's Hospital
Those capable of undergoing imaging studies, including Brain MRI and Amyloid PET CT
Individuals able to complete cognitive function tests, such as the Alzheimer's Disease Consortium test battery, K-MMSE, CDR, and GDS
Individuals with progressive mental or neurological disorders (including those with a history of psychotic disorders such as major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychosis; patients currently experiencing major depressive disorder with psychotic symptoms; organic mental disorders; epilepsy or seizure disorders; patients currently suffering from eating disorders or obsessive-compulsive disorder).
Individuals with unstable or severe medical conditions.
Patients with severe snoring, REM sleep behavior disorder, or narcolepsy.
Illiterate individuals.
Parallel
Melatonin
Drug3months melatonin
Cognitive behavioral therapy group for insomnia
Behavioral15minutes 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.
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
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.
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.
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.
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.
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.
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.
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