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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorSaint Vincent's Hospital, Korea

About this trial

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. Does melatonin administration alter the levels of blood biomarkers associated with Alzheimer's disease? 2. What changes occur in sleep-related subjective report questionnaire scores and cognitive function scores following melatonin administration? 3. Does melatonin administration effect on physical performance? 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.

Participants Will:

1. Take melatonin every day for 3 months and Complete sleep-related subjective report questionnaires, neuropsychological assessments and physical performance test 2. Visit the clinic at the initial visit and after 3 months for checkups and tests. 3. Complete sleep-related subjective report questionnaires and neuropsychological assessments and physical performance test 4. Provide blood samples for biomarker analysis.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Melatonin
  • Cognitive behavioral therapy group for insomnia

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations