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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
56 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 16 visits
  • Procedures mentioned: Spinal tap (lumbar puncture), Blood draws, Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED."
  • "BUT ARE CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING."
  • "They will receive a phone call at the beginning of week-9 to complete brief questionnaires regarding sleep quality, mood, and any physical symptoms that may be associated with study-issued medications."
  • "At the week-16 visit, the participants will return their actigraphy watches, complete brief cognitive testing, questionnaires on sleep quality, mood, physical symptoms that may be associated with study-issued medications, and complete the first LP and blood draw."
  • "They will receive a phone call around week-30 (midway between week-16 and the final study visit of week-44) to inquire about sleep quality, any physical symptoms that may be associated with study-issued medications, and mood."
  • "The visit will be very similar to the baseline visit and will include comprehensive cognitive testing, questionnaires, and an LP."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether 5 mg of melatonin taken for 9 months improves memory, thinking, and signs of Alzheimer's disease. It is for adults ages 56–85, with or without mild memory and thinking problems. Testing includes memory and thinking tests and two blood draws; spinal taps are no longer used as of August 2024.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 56–85 years old.
  • Score at least 18 on the Montreal Cognitive Assessment (MoCA), a memory and thinking test.
  • Have a Clinical Dementia Rating (CDR) Sum of Boxes score below 1, a measure of problems with thinking and daily tasks.
  • Be able and willing to stop all prescription and over-the-counter sleep aids, including melatonin, except those given by the study.
  • Have a body mass index (BMI) below 35 when joining. BMI compares weight with height.
  • Bring a spouse, child, or friend who knows you well to all four study visits.

Who can't join

  • Have sleep apnea (breathing pauses during sleep) without using a CPAP breathing machine, or have COPD or emphysema (lung diseases).
  • Have a major mental illness, such as bipolar disorder or schizophrenia, or a history of alcohol or drug abuse.
  • Have a disease affecting the brain or nerves, such as Parkinson's disease, Lewy body disease, ALS, or MS.
  • Have had a stroke or a brain injury from trauma.
  • Have had chemotherapy in the past 2 years, or a hospital stay for injury or surgery in the past 3 months.
  • Have a CDR score of 1 or higher, or significant depression or anxiety (GDS or GAI score of 9 or higher).
  • Take fluvoxamine (Luvox), fluoxetine (Prozac), or nifedipine, a blood pressure drug.
  • Take blood thinners, anti-seizure drugs, muscle relaxants, or opioid pain medicines.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

IA