Not yet recruitingPhase NA

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

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

Lead sponsor

Saint Vincent's Hospital, Korea

Asset

Melatonin

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 60-90

Primary endpoints

•Phosphorylated tau 217 (p-tau217)•Serum Glial Fibrillary Acidic Protein (GFAP) Levels•Neurofilament light (NfL)

Identifiers

Registered as

NCT IDNCT06756828

Org study IDVC24OISI0285

Timeline

Milestones

Study first posted2025-01-03actual

Last update posted2025-01-03actual

Study start2025-01-15estimated

Primary completion2026-08-30estimated

Study completion2026-12-30estimated

Assets

Drug assets

Melatonin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Behavior / neuropsychiatric

Neurodegeneration biomarkers

Other (unclassified)

Tau biomarkers

Other clinical outcomes

Global cognition

8 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Verbal Fluency Scores from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Word List Recall Scores from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Word List Recognition Scores from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Constructional recall from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change in Pittsburgh Sleep Quality Index (PSQI) Global Scores from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint

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

Phosphorylated tau 217 (p-tau217)

descriptive

Tau biomarkers

1 endpoint

Primary/protocol endpoint

Change in Serum p-Tau 217 Levels from Baseline to Week 12

Time frame:Baseline and Week 12

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Neurodegeneration biomarkers

2 endpoints

Primary/protocol endpoint

Change in Serum Glial Fibrillary Acidic Protein (GFAP) Levels from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Primary/protocol endpoint

Change in Serum Neurofilament Light Chain (NfL) Levels from Baseline to Week 12

Time frame:Baseline and Week 12

Neurofilament light (NfL)

change from baseline, improvement

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Change in Physical Performance from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in Insomnia Severity Index (ISI) Scores from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Epworth Sleepiness Scale (ESS) Scores from Baseline to Week 12

Time frame:Baseline and Week 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.