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NCT06756828
Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum
NA trial testing Melatonin in Elderly in 40 participants. Not yet recruiting.
30 August 2026
Quick facts
| Lead sponsor | Saint Vincent's Hospital, Korea |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 15 January 2025 |
| Primary completion | 30 August 2026 |
| Estimated completion | 30 December 2026 |
Drugs / interventions tested
- Melatonin (MELATONIN) — full drug profile →
- Cognitive behavioral therapy group for insomnia
Conditions studied
- Elderly — all drugs for Elderly →
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Melatonin — all drugs for Melatonin →
- Cognitive Decline — all drugs for Cognitive Decline →
Sponsor
Saint Vincent's Hospital, Korea
Who can join
Adults 60 to 90, any sex, with Elderly or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06756828
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06756828 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Saint Vincent's Hospital, Korea
- Last refreshed: 3 January 2025
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