Actively Recruiting
Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
Led by Natalie Denburg · Updated on 2025-03-04
230
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between ages of 56 and 85 years
- Score 18 or above on the Montreal Cognitive Assessment (MoCA)
- Clinical dementia rating (CDR) sum of boxes less than 1
- Willing to stop using any prescription or non-prescription sleep aids except study-issued medications
- Body mass index (BMI) less than 35 at enrollment
- Willing to bring a study partner who knows them well to all visits
You will not qualify if you...
- Diagnosis of obstructive sleep apnea without CPAP use
- Diagnosis of chronic obstructive pulmonary disease or emphysema
- Major psychiatric diseases such as bipolar disorder or schizophrenia
- History of alcohol or drug abuse
- Diagnosis of neurodegenerative diseases like Parkinson's, Lewy body dementia, ALS, or MS
- Prior stroke or traumatic brain injury
- Chemotherapy treatment in the past 2 years
- Hospitalization for injury or surgery in the past 3 months
- Clinical dementia rating (CDR) of 1 or greater
- Clinically significant depression or anxiety (GDS score 9 or higher; GAI score 9 or higher)
- Current use of specific medications including Fluvoxamine, Fluoxetine, Nifedipine, all anticoagulants, anti-seizure drugs, muscle relaxants, or narcotic pain relievers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
N
Natalie Denburg, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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