ElderlyNCT06756828
Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum
A study testing Melatonin and Cognitive behavioral therapy group for insomnia in people with Elderly and Alzheimer Disease, run by Saint Vincent's Hospital, Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Elderly, Alzheimer Disease, Melatonin
- What is being tested?
- Melatonin and Cognitive behavioral therapy group for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on Regional Structural Changes in the Cerebellum Associated with Blood Biomarkers, Cognitive Decline, and Physical Performance in Alzheimer's Spectrum Patients Following a 3-Month Melatonin Treatment Using Digital Health Technology
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:
- Does melatonin administration alter the levels of blood biomarkers associated with Alzheimer's disease?
- What changes occur in sleep-related subjective report questionnaire scores and cognitive function scores following melatonin administration?
- Does melatonin administration effect on physical performance?
- 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.
Read more
Participants Will:
- Take melatonin every day for 3 months and Complete sleep-related subjective report questionnaires, neuropsychological assessments and physical performance test
- Visit the clinic at the initial visit and after 3 months for checkups and tests.
- Complete sleep-related subjective report questionnaires and neuropsychological assessments and physical performance test
- Provide blood samples for biomarker analysis.
- Conditions
- Elderly, Alzheimer Disease, Melatonin, Cognitive Decline, Biomarker with Neurodegeneration Patients, Cerebellum
- Being tested
- Melatonin, Cognitive behavioral therapy group for insomnia
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
3months melatonin
Cognitive behavioral therapy group for insomniaBehavioural
15minutes of sleep hygiene education on the first day of visiting the hospital
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Experimental | Taking 2mg of melatonin 2 hours before going to bed for 12 weeks. Receives: Drug: Melatonin |
| Cognitive behavioral therapy group | Other | 15minutes of sleep hygiene education on the first day of visiting the hospital Receives: Behavioral: Cognitive behavioral therapy group for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoo Hyun Um Um, Assitant professor, Ph.D, MD, Principal investigator, St.Vincent's Hospital, College of Medicine, Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756828
- Sponsor's protocol ID
- VC24OISI0285
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Regional Structural Changes in the Cerebellum Associated with Blood Biomarkers, Cognitive Decline, and Physical Performance in Alzheimer's Spectrum Patients Following a 3-Month Melatonin Treatment Using Digital Health Technology
- ClinicalTrials.gov ID
- NCT06756828
- Acronym / sponsor ID
- VC24OISI0285
- Conditions
- Elderly, Alzheimer Disease, Melatonin, Cognitive Decline, Biomarker with Neurodegeneration Patients, Cerebellum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does melatonin administration alter the levels of blood biomarkers associated with Alzheimer's disease?
- What changes occur in sleep-related subjective report questionnaire scores and cognitive function scores following melatonin administration?
- Does melatonin administration effect on physical performance?
- 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:
- Take melatonin every day for 3 months and Complete sleep-related subjective report questionnaires, neuropsychological assessments and physical performance test
- Visit the clinic at the initial visit and after 3 months for checkups and tests.
- Complete sleep-related subjective report questionnaires and neuropsychological assessments and physical performance test
- Provide blood samples for biomarker analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Experimental | Drug: MelatoninTaking 2mg of melatonin 2 hours before going to bed for 12 weeks. |
| Cognitive behavioral therapy group | Other | Behavioral: Cognitive behavioral therapy group for insomnia15minutes of sleep hygiene education on the first day of visiting the hospital |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin3months melatonin | Drug | Melatonin group |
| Cognitive behavioral therapy group for insomnia15minutes of sleep hygiene education on the first day of visiting the hospital | Behavioural | Cognitive behavioral therapy group |
Primary outcome
Change in Serum p-Tau 217 Levels from Baseline to Week 12
Time frame: Baseline and 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
Time frame: Baseline and 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
Time frame: Baseline and 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
Time frame: Baseline and 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.
12 secondary outcomes
Change in Global Deterioration Scale (GDS) Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Clinical Dementia Rating (CDR) Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Verbal Fluency Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Mini-Mental State Examination (MMSE) Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Boston Naming Test (BNT) Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Word List Recall Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Word List Recognition Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Constructional recall from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Pittsburgh Sleep Quality Index (PSQI) Global Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Insomnia Severity Index (ISI) Scores from Baseline to Week 12
Time frame: Baseline and Week 12
Change in Epworth Sleepiness Scale (ESS) Scores from Baseline to 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
Time frame: At the time of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Related trials for Elderly
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoo Hyun Um Um, Assitant professor, Ph.D, MD principal investigator
St.Vincent's Hospital, College of Medicine, Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Cognitive behavioral therapy group for insomnia in people with Elderly and Alzheimer Disease, run by Saint Vincent's Hospital, Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoo Hyun Um,, Ph.MD (82+31-249-7150, cherubic712@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum p-Tau 217 Levels from Baseline to Week 12 (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.