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New treatment option for Mild Cognitive Impairment
Official title Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
ClinicalTrials.gov ID: NCT03954899
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 56 to 85. Healthy volunteers may be eligible.
You may be able to join if
- between ages of 56-85 years
- all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);
- all participants must have a clinical dementia rating (CDR) Sum of boxes \<1;
- need to be willing to undergo CSF LP on two occasions over the course of their participation,
- 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...
You likely can't join if
- are:
- Individuals with any of the following conditions/ diseases will be excluded: Obstructive sleep apnea (OSA) without CPAP use, chronic obstructive...
- CDR\>=1, clinically significant depression/anxiety (GDS\>=9; GAI\>=9 ),
- Participants who are on any of the following medications will be excluded: Fluvoxamine (Luvox)/ Fluoxetine (Prozac), Nifedipine (a blood pressure...
See the full eligibility criteria
- between ages of 56-85 years
- all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);
- all participants must have a clinical dementia rating (CDR) Sum of boxes \<1;
- need to be willing to undergo CSF LP on two occasions over the course of their participation,
- 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...
- BMI \< 35 at the time of enrollment
- 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...
- are:
- 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...
- CDR\>=1, clinically significant depression/anxiety (GDS\>=9; GAI\>=9 ),
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 56 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.