Effects of melatonin on brain health and cognition in older adults
Evaluating the Disease Modifying Potential of a Sleep Intervention on Alzheimer's Disease (AD) Biomarkers
This study is testing if taking 5mg of melatonin can improve brain health and thinking skills in older adults, especially those with mild cognitive impairment, over nine months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 56 Years to 85 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT03954899 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of 5mg of melatonin on cognitive function and Alzheimer's disease biomarkers in older adults over a 9-month period. Participants, aged 56-85, will be categorized into two groups based on their cognitive status: those with mild cognitive impairment (MCI+) and those without (MCI-). The study will involve baseline cognitive assessments, followed by randomization into either a melatonin or placebo group. Participants will also wear actigraphy watches to monitor their sleep patterns throughout the study.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 56-85 who have a MoCA score of 18 or above and a clinical dementia rating of less than 1.
Not a fit: Patients with severe cognitive impairment or those currently using other sleep aids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive health and quality of life for older adults at risk of cognitive decline.
How similar studies have performed: While some studies have explored melatonin's effects on sleep and cognition, this specific approach focusing on Alzheimer's biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Iowa City, Iowa
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Natalie Denburg, Ph.D. — University of Iowa
- Study coordinator: Natalie Denburg, Ph.D
- Email: natalie-denburg@uiowa.edu
- Phone: 3193846050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.