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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:
Participants Will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin group | Experimental | Taking 2mg of melatonin 2 hours before going to bed for 12 weeks. |
|
| Cognitive behavioral therapy group | Other | 15minutes of sleep hygiene education on the first day of visiting the hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 3months melatonin |
| |
| Cognitive behavioral therapy group for insomnia |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoo Hyun Um,, Ph.MD | Contact | 82+31-249-7150 | cherubic712@naver.com | |
| Suhyung Kim, MD | Contact | 82+31-249-8171 | suhyeong.k@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yoo Hyun Um Um, Assitant professor, Ph.D, MD | St.Vincent's Hospital, College of Medicine, Catholic University of Korea | Principal Investigator |
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| Behavioral |
15minutes of sleep hygiene education on the first day of visiting the hospital |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At the time of enrollment |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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