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Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
Sponsor: Natalie Denburg
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.
Official title: Evaluating the Disease Modifying Potential of a Sleep Intervention on Alzheimer's Disease (AD) Biomarkers
Key Details
Gender
All
Age Range
56 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2019-11-12
Completion Date
2025-11
Last Updated
2025-03-04
Healthy Volunteers
Yes
Interventions
melatonin
5mg of melatonin-otc 30 minutes before sleep
placebo
placebo 30 minutes before sleep
Locations (1)
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States