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

Launched by SAINT VINCENT'S HOSPITAL, KOREA · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of melatonin, a natural sleep aid, on patients with early signs of Alzheimer's disease, particularly those who also have trouble sleeping. Researchers want to see if taking melatonin for three months can change certain blood markers linked to Alzheimer's, improve sleep and cognitive abilities, and affect physical performance. They will compare the participants' health measures before and after the treatment to understand how melatonin might help slow down the progression of Alzheimer's disease.

To participate, individuals should be between 60 and 90 years old and experiencing some level of cognitive decline. They must also be able to complete specific tests and undergo brain imaging. Participants will take melatonin daily for three months and visit the clinic for check-ups and tests, including providing blood samples. This trial is not yet recruiting, so if you or a loved one are interested, keep an eye out for updates!

Gender

ALL

Eligibility criteria

• 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.