Start: November 12, 2019
End: November 2025
What Is This Study About?
Melatonin is a hormone involved in regulating sleep cycles that's also sold as an over-the-counter supplement. This clinical trial will examine whether melatonin can improve Alzheimer's disease biomarkers and cognitive function in older adults with and without mild cognitive impairment. Participants will be randomly assigned to take 5 mg of melatonin or a placebo pill 30 minutes before bedtime for nine months. Researchers will measure changes in memory and cognitive function, as well as levels of proteins in cerebrospinal fluid. Participants will also wear an actigraphy watch that measures cycles of activity and rest.
Do I Qualify To Participate in This Study?
- Montreal Cognitive Assessment score of 18 or above
- Clinical Dementia Rating sum of boxes score less than 1
- Willing to undergo lumbar puncture on three occasions
- Able and willing to stop using any sleep aids, except study-issued medications. for the study duration
- Body mass index less than 35
- Study partner who knows participant well and can attend four visits
Must NOT have:
- Obstructive sleep apnea, chronic obstructive pulmonary disease, or emphysema
- Major psychiatric disease, such as bipolar or schizophrenia
- History of alcohol or drug abuse
- Diagnosis of neurodegenerative disease, including Parkinson's, Lewy body dementia, amyotrophic lateral sclerosis, and multiple sclerosis
- History of stroke or traumatic brain injury
- Chemotherapy in past 2 years
- Hospitalized for injury or surgery in past 3 months
- Significant depression/anxiety (score of 9 or more on the Geriatric Depression Scale or Geriatric Anxiety Inventory)
- Prohibited medications: fluvoxamine, fluoxetine, nifedipine, anticoagulants (e.g., warfarin, heparin), antiseizure drugs, muscle relaxants, narcotic pain relievers (e.g., codeine, tramadol, hydrocodone)
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Natalie Denburg, Ph.D
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Nazan Aksan
Source: ClinicalTrials.gov ID: NCT03954899