Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT03954899). This is a study registration, not published results. Lead sponsor: Natalie Denburg. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 230 participants (ESTIMATED). Conditions: Mild Cognitive Impairment, Cognitive Decline, Healthy Aging. Interventions: DIETARY_SUPPLEMENT: melatonin; OTHER: placebo. Primary outcome measures: Episodic memory , Assessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44.. Brief summary: The study will examine whether 5mg melatonin (over the counter, OTC) over a 9-month period improves Alzheimer's disease (AD) biomarkers and cognitive function in two groups of individuals: those with mild cognitive impairment (MCI+) and those who are not (MCI-). AD biomarkers will be measured from cerebrospinal fluid (CSF) obtained from lumbar punctures. Cognitive function will be evaluated with routine neuropsychological tests. AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. BUT ARE CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING.