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Melatonin for Cognition and Brain Health in Aging

Recruiting

This clinical trial will examine whether the supplement melatonin can improve Alzheimer's disease biomarkers and cognitive function in older adults with and without mild cognitive impairment.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 80 Years All Yes
September 30, 2019
October 2024
230

  • 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 30
  • Study partner who knows participant well and can attend four visits

  • 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)

Melatonin is a hormone involved in regulating sleep cycles that's also sold as an over-the-counter supplement. In this study participants will be randomly assigned to take 5 mg of melatonin or a placebo pill 30 minutes before bedtime for 9 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.

Name City State Zip Status Primary Contact
University of Iowa Hospitals & Clinics
Iowa City Iowa 52242 Recruiting nazan aksan
319-356-8112
nazan-aksan@uiowa.edu

Nazan Aksan

Name Role Affiliation
Nazan Aksan Principal Investigator University of Iowa

Name Phone Email
Nazan Aksan, PhD 319-356-8112 nazan-aksan@uiowa.edu

NCT03954899

Evaluating the Disease Modifying Potential of a Sleep Intervention on Alzheimer's Disease (AD) Biomarkers