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RECRUITING
NCT03954899
NA

Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging

Sponsor: Natalie Denburg

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

melatonin

5mg of melatonin-otc 30 minutes before sleep

OTHER

placebo

placebo 30 minutes before sleep

Locations (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States