5mg Melatonin for Cognitive Health in Aging

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

Recruiting N/A Interventional Study
Mild Cognitive Impairment Cognitive Decline Healthy Aging
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
56 – 85
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
230 (estimated)
Sponsor
Natalie Denburg · Other
Who this trial is looking for

This trial is looking for older adults to see if taking 5mg of melatonin can improve brain health and cognitive function. Participants will have two blood tests to check brain health during a 9-month period.

Are You a Good Fit for This Trial?
Must not be taking FluvoxamineFluoxetineNifedipineWarfarinHeparinGabapentin
Rules you out Obstructive sleep apneaNeurodegenerative diseaseStrokeTraumatic brain injuryClinical depressionClinical anxiety

You may be able to join if

  • I am between the ages of 56 and 85.
  • I have a score of 18 or above on the Montreal Cognitive Assessment.
  • I have a clinical dementia rating score of less than 1.
  • I am willing to stop using all sleep aids, except the study medication.
  • I have a body mass index (BMI) of less than 35.
  • I can bring a study partner to my visits.

You may not be able to join if

  • I have obstructive sleep apnea without using a CPAP machine.
  • I have been diagnosed with a neurodegenerative disease.
  • I have had a stroke or traumatic brain injury in the past.
  • I have been hospitalized for an injury or surgery in the last 3 months.
  • I have clinical depression or anxiety with significant symptoms.
  • I am taking medications like fluvoxamine or fluoxetine.
  • I am on any blood thinners or anti-seizure drugs.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 r…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. between ages of 56-85 years 2. all participants must score 18 or above on Montreal Cognitive Assessment (MoCA); 3. all participants must have a clinical dementia rating (CDR) Sum of boxes \<1; 4. need to be willing to undergo CSF LP on two occasions over the course of their p…
Contacts

Natalie Denburg, Ph.D

3193846050

natalie-denburg@uiowa.edu

CONTACT