NCT03954899 Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
| NCT ID | NCT03954899 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Natalie Denburg |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2019-11-12 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2019-11-12 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 participation, 5. 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 6. BMI \< 35 at the time of enrollment 7. 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: 1. 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. 2. CDR\>=1, clinically significant depression/anxiety (GDS\>=9; GAI\>=9 ), 3. 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).
Contact & Investigator
Natalie Denburg, Ph.D.
PRINCIPAL INVESTIGATOR
University of Iowa
Frequently Asked Questions
Who can join the NCT03954899 clinical trial?
This trial is open to participants of all sexes, aged 56 Years or older, up to 85 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03954899 currently recruiting?
Yes, NCT03954899 is actively recruiting participants. Contact the research team at natalie-denburg@uiowa.edu for enrollment information.
Where is the NCT03954899 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT03954899 clinical trial?
NCT03954899 is sponsored by Natalie Denburg. The principal investigator is Natalie Denburg, Ph.D. at University of Iowa. The trial plans to enroll 230 participants.