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

NCT03954899 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

melatonin

5mg of melatonin-otc 30 minutes before sleep

OTHER

placebo

placebo 30 minutes before sleep

Sponsors & Collaborators

  • Natalie Denburg

    lead OTHER

Principal Investigators

  • Natalie Denburg, Ph.D. · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
56 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954899 on ClinicalTrials.gov