Melatonin for Cognition and Brain Health in Aging
This study is investigating whether taking 5mg of over-the-counter melatonin for nine months can improve memory and brain health in people aged 56-85. Researchers are interested in two groups: those with mild cognitive impairment (MCI), which is a slight but noticeable decline in mental abilities, and those with healthy aging. The study will measure changes in memory through tests and look at certain markers in the blood related to Alzheimer's disease. You would either receive melatonin or a placebo (an inactive substance) without knowing which one. The goal is to see if melatonin can help protect brain health as we age.
- Study design
- This is an interventional study planning to enroll 230 participants, who will be randomly assigned to receive either melatonin or a placebo.
- What's involved
- Participants will have a baseline visit, wear a sleep-monitoring watch for 8 weeks, and have two blood draws for biomarker testing. The study involves a 9-month treatment period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Episodic memory will be assessed at 16 weeks and 44 weeks after treatment begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
At a glance
Conditions
NCT03954899
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Iowa Hospitals & Clinics
Iowa City, Iowastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Natalie Denburg, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Iowa
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Episodic memoryAssessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44.
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 pretreatment group mean and standard deviations to permit the detection of deviation from pre-treatment levels.