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NCT03954899 · ClinicalTrials.gov registry record · NA

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

A NA study of Mild Cognitive Impairment and Cognitive Decline, sponsored by Natalie Denburg.

Recruiting
Registry status
NA
Development phase
230
Enrollment target
1
Study location

NCT03954899: Recruiting NA study of Mild Cognitive Impairment and Cognitive Decline, sponsored by Natalie Denburg.

NCT03954899 is a NA study of Mild Cognitive Impairment and Cognitive Decline that is actively recruiting participants, run by Natalie Denburg. The registered enrollment target is 230 participants, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03954899, a NA study of Mild Cognitive Impairment and Cognitive Decline, is actively recruiting participants, sponsored by Natalie Denburg.

RECRUITING
Registry status
NA
Development phase
230 participants
Enrollment target
1
Study location

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.

Primary Outcome

Composite episodic memory performance scores will be computed based on the following tests: Auditory Verbal Learning Test (AVLT), Free \& Cued Selective Reminding Test (FCSRT), Repeatable Battery for the Assessment of Neuropsychological Status (Story memory) at the week-8, week-16, and week-44 visits. Alternate forms will be used to assess performance in each of these tests across these visits to minimize practice effects. Composite scores at week-16 and week-44 visits will reference the pretrea

Conditions Studied

Mild Cognitive Impairment Cognitive Decline Healthy Aging

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
Natalie Denburg

1 total trials

What NCT03954899 shows while recruiting

NCT03954899 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (82% lower).

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.

NCT03954899 reports a single indexed study location in Iowa.

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.

What interventions are being tested in trial NCT03954899?

The interventions under investigation include: placebo (OTHER), melatonin (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT03954899?

This trial is sponsored by Natalie Denburg, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Mild Cognitive Impairment

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03954899's enrollment target sits among peer trials

230 41st of 205 higher than 165 of 205 other Mild Cognitive Impairment trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT03954899

Source: ClinicalTrials.gov NCT03954899, the US trial registry maintained by the National Library of Medicine. NCT03954899 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.