Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT03954899 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER placebo
  • DIETARY_SUPPLEMENT melatonin

Study Locations (1)

Iowa

  • University of Iowa Hospitals & Clinics — Iowa City

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2019-11-12
Est. Completion 2025-11
Phase NA

Sponsor

Natalie Denburg

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03954899

The ClinicalTrials.gov registry entry for NCT03954899 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Natalie Denburg, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03954899 reports 1 study location spanning 1 distinct geographic area — top geographies include Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03954899 about?

NCT03954899 is a clinical study titled "Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging". 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 c...

What is the current status of trial NCT03954899?

This trial is currently recruiting. It is a NA study. The enrollment target is 230 participants. The study started on 2019-11-12. Estimated completion is 2025-11.

What conditions does trial NCT03954899 study?

This clinical trial studies the following conditions: Mild Cognitive Impairment, Cognitive Decline, Healthy Aging. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03954899?

The interventions under investigation include: placebo (OTHER), melatonin (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03954899?

This trial is sponsored by Natalie Denburg, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03954899 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial