NCT03954899Recruiting
Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
Evaluating the Disease Modifying Potential of a Sleep Intervention on Alzheimer's Disease (AD) Biomarkers
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 15 May 2019
- Start date
- 12 Nov 2019
- Primary completion date
- Feb 2028
- Lead sponsor
- Natalie Denburg
- Diseases
- Alzheimer disease
- NCT number
- NCT03954899
What you commit to
- Study type: Interventional
- Planned participants: 230
- From 12 Nov 2019 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- between ages of 56-85 years
- all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);
- all participants must have a clinical dementia rating (CDR) Sum of boxes \<1;
- need to be willing to undergo CSF LP on two occasions over the course of their participation,
- need to be able and willing to stop using any prescription or non-prescription sleep aids (e.g.(e.g. Ambien, Sonata, Lunesta, Belsomra, Rozerem, Halcion, Intermezzo, Doxepin, Melatonin, etc.) for the duration of the study except for study-issued medications
- BMI \< 35 at the time of enrollment
- willing to bring a study partner (spouse, child or friend) who knows them well to each of the four visits
- 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.
- The exclusion criteria are:
- Individuals with any of the following conditions/ diseases will be excluded:
- Obstructive sleep apnea (OSA) without CPAP use, chronic obstructive pulmonary disease, emphysema, major psychiatric disease (bipolar, schizophrenia), history of alcohol/drug abuse, neurodegenerative disease diagnosis (e.g. Parkinson's, Lewy body, ALS, MS), prior history of stroke or traumatic brain injury, have undergone chemotherapy in the past 2 years, have been hospitalized for injury/surgery in the past three-months.
- CDR\>=1, clinically significant depression/anxiety (GDS\>=9; GAI\>=9 ),
- Participants who are on any of the following medications will be excluded: Fluvoxamine (Luvox)/ Fluoxetine (Prozac), Nifedipine (a blood pressure medication), all anti-coagulants (e.g. Warfarin, Coumadin, Heparin, , Lovenox, Xarelto, Pradaxa, etc.), anti-seizure drugs (e.g. Acetazolamide, Carbamazepine, Clobazam, Clonazepam, Gabapentin, etc.), muscle relaxants (e.g.Baclofen, Valium/ diazepam, Flexeril, etc.), or narcotic pain relievers (e.g.Codeine, Tramadol, Hydrocodone, Demerol, etc).
Age in the registry: 56 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Hospitals & Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.