Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06756828
Brief 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 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.
Study:
NCT06756828
Study Brief:
Protocol Section:
NCT06756828