NCT06756828 · NOT YET RECRUITING
Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum
This trial is testing whether three months of nightly melatonin can slow the progression of Alzheimer's-related changes in people who already have mild cognitive impairment and insomnia. Researchers will track blood biomarkers tied to brain injury, sleep quality, physical function, and cerebellar brain volume before and after treatment. This is a Phase NA study, meaning it is exploratory — designed to gather early data, not to prove a treatment works.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-03