Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum

NCT06756828 | Not Yet Recruiting DMC

• 1 other identifier: VC24OISI0285
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Does melatonin administration alter the levels of blood biomarkers associated with Alzheimer's disease?
2. 2.What changes occur in sleep-related subjective report questionnaire scores and cognitive function scores following melatonin administration?
3. 3.Does melatonin administration effect on physical performance?
4. 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.
5. 5.Take melatonin every day for 3 months and Complete sleep-related subjective report questionnaires, neuropsychological assessments and physical performance test
6. 6.Visit the clinic at the initial visit and after 3 months for checkups and tests.
7. 7.Complete sleep-related subjective report questionnaires and neuropsychological assessments and physical performance test
8. 8.Provide blood samples for biomarker analysis.

Conditions

Elderly; Alzheimer Disease; Melatonin; Cognitive Decline; Biomarker with Neurodegeneration Patients; Cerebellum

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (12)

• Change in Global Deterioration Scale (GDS) Scores from Baseline to Week 12

  Baseline and Week 12

• Change in Clinical Dementia Rating (CDR) Scores from Baseline to Week 12

  Baseline and Week 12

• Change in Verbal Fluency Scores from Baseline to Week 12

  Baseline and Week 12

• Change in Mini-Mental State Examination (MMSE) Scores from Baseline to Week 12

  Baseline and Week 12

• Change in Boston Naming Test (BNT) Scores from Baseline to Week 12

  Baseline and Week 12

Study Arms (2)

Melatonin group

EXPERIMENTAL

Taking 2mg of melatonin 2 hours before going to bed for 12 weeks.

Drug: Melatonin

Cognitive behavioral therapy group

OTHER

15minutes of sleep hygiene education on the first day of visiting the hospital

Behavioral: Cognitive behavioral therapy group for insomnia

Interventions

Melatonin DRUG

3months melatonin

Melatonin group

Cognitive behavioral therapy group for insomnia BEHAVIORAL

15minutes of sleep hygiene education on the first day of visiting the hospital

Cognitive behavioral therapy group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participants who can perform tests at the hospital's Smart Center, including the Short Physical Performance Battery and body composition analysis using direct segmental multi-frequency bioelectrical impedance analysis for sarcopenia
• Individuals on acetylcholinesterase inhibitors (ACEi) or NMDA receptor antagonists who have maintained the same dosage and regimen for more than 3 months from the screening date.
• Patients who are taking medications for cognitive function treatment other than acetylcholinesterase inhibitors and NMDA receptor antagonists (e.g., pregabalin, gabapentin, choline alfoscerate), as well as medications for chronic diseases such as antidepressants, antihypertensives, diabetes, hyperlipidemia, thyroid disorders, etc., must have maintained the same dosage and regimen for more than 1 month from the screening date.
• Individuals with sufficient language proficiency to read and understand the informed consent document and respond to survey questionnaires

You may not qualify if:

• 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.
• Individuals who, in the opinion of the investigator, are deemed unable to comply with the requirements of the study.
• Patients currently taking sleeping pills within 2 weeks of the screening point.

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Yoo Hyun Um Um, Assitant professor, Ph.D, MD

  St.Vincent's Hospital, College of Medicine, Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 3, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-12