[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Natalie Denburg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100359040","disease-modifying-potential-of-5mg-of-melatonin-on-cognition-and-brain-health-in-aging-100359040",false,"NCT03954899","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","Inclusion Criteria:\n\n1. between ages of 56-85 years\n2. all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);\n3. all participants must have a clinical dementia rating (CDR) Sum of boxes \\\u003C1;\n4. need to be willing to undergo CSF LP on two occasions over the course of their participation,\n5. 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\n6. BMI \\\u003C 35 at the time of enrollment\n7. willing to bring a study partner (spouse, child or friend) who knows them well to each of the four visits\n\nAS 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.\n\nThe exclusion criteria are:\n\n1. Individuals with any of the following conditions\u002F diseases will be excluded:\n\n   Obstructive sleep apnea (OSA) without CPAP use, chronic obstructive pulmonary disease, emphysema, major psychiatric disease (bipolar, schizophrenia), history of alcohol\u002Fdrug 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\u002Fsurgery in the past three-months.\n2. CDR\\>=1, clinically significant depression\u002Fanxiety (GDS\\>=9; GAI\\>=9 ),\n3. Participants who are on any of the following medications will be excluded: Fluvoxamine (Luvox)\u002F 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\u002F diazepam, Flexeril, etc.), or narcotic pain relievers (e.g.Codeine, Tramadol, Hydrocodone, Demerol, etc).",true,"ALL","56 Years","85 Years",{"count":21,"type":22},230,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nAS 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.",[28,29,30],"Mild Cognitive Impairment","Cognitive Decline","Healthy Aging","RECRUITING","2026-09-23",{"date":34,"type":35},"2026-09-28","ACTUAL",{"date":37,"type":35},"2019-11-12",{"date":39,"type":22},"2028-02",{"name":41,"class":42},"Natalie Denburg","OTHER",""]