Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging

Description

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.

Conditions

Mild Cognitive Impairment, Cognitive Decline, Healthy Aging

Study Overview

Study Details

Study overview

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.

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

Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging

Condition
Mild Cognitive Impairment
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States, 52242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Individuals with any of the following conditions/ diseases will be excluded:
  • 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).

Ages Eligible for Study

56 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Natalie Denburg,

Natalie Denburg, Ph.D., PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

2025-11