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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 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.
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.
Conditions Studied
Interventions
- OTHER placebo
- DIETARY_SUPPLEMENT melatonin
Study Locations (1)
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2019-11-12 |
| Est. Completion | 2025-11 |
| Phase | NA |
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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, categorized as NA. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (82% lower). The listed sponsor is Natalie Denburg, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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