[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460970":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":32,"enrollmentInfo":81,"targetDuration":32,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Trazodone First","ACTIVE_COMPARATOR","Trazodone (50 mg at bedtime) and then placebo after a 4-week washout period.",[13,14],"Drug: Trazodone","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo First","PLACEBO_COMPARATOR","Placebo and then Trazodone (50 mg at bedtime) after a 4-week washout period.",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Trazodone","50mg of trazodone administered for 4 weeks.",[16,9],[27],"Desyrel",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Placebo administered for 4 weeks.",[16,9],null,[34],{"name":35,"affiliation":5,"role":36},"Barry Greenberg, PhD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","410-955-1696","bgreen45@jhmi.edu",{"name":43,"role":39,"phone":44,"phoneExt":32,"email":45},"Paul Rosenberg, MD","410-550-9883","prosenb9@jhmi.edu",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Johns Hopkins Hospital","RECRUITING","Baltimore","Maryland","21205","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-76.61219,39.29038,{"lat":59,"lon":58},[62,63,64],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":32,"email":45},{"name":35,"role":36,"phone":32,"phoneExt":32,"email":32},{"type":66,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[68],{"name":69,"class":70},"National Institute on Aging (NIA)","NIH","100460970","phase-2-targeting-cognition-in-early-alzheimers-disease-by-improving-sleep-with-trazodone-100460970",false,"NCT05282550","Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone","RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (REST)","REST","Inclusion Criteria:\n\n1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and\u002For objective evidence of memory problems;\n2. Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \\>=0.5;\n3. Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of \\>5 (a well-validated cutoff observed in \\>40% of older persons);\n4. Memory performance \\> 1.5 Standard Deviation (SD) below age-and education-matched control subjects on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) List Recall;\n5. Visual and auditory acuity adequate for neuropsychological testing;\n6. Good general health with no disease expected to interfere with the study;\n7. Able to have Magnetic Resonance Imaging (MRI) scan;\n8. Availability of knowledgeable informant (KI)\n9. Buschke Selective Reminding Test or more standard deviations below age-education norms\n\nExclusion Criteria:\n\n1. Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;\n2. Too frail or medically unstable to undergo study procedures;\n3. Prior diagnosis of Obstructive Sleep Apnea (OSA) or evidence of moderate-to-severe OSA on baseline Home Sleep Test (HST) as evidenced by an apnea\u002Fhypopnea index of \\>15;\n4. Dementia;\n5. Cognitive complaints and deficits better explained by other medical\u002Fneurologic conditions;\n6. Delirium;\n7. Allergic to trazodone;\n8. Taking sleep medications including trazodone;\n9. Current substance abuse;\n10. Current major depressive, manic, or acute psychotic episode;\n11. Prior diagnosis of significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's Disease (AD) pathology:\n12. Lack of available KI;\n13. Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \\> 470 msec (females) or \\> 450 msec (males);\n14. Inability to provide informed consent","ALL","55 Years",{"count":82,"type":83},100,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","To investigate the effect of trazodone on sleep, hippocampal-dependent memory and hippocampal excitability. The investigators hypothesize that trazodone will improve total sleep time and proportion of time in Slow Wave Sleep (SWS).",[89,90],"AMCI - Amnestic Mild Cognitive Impairment","Sleep Disturbance",[92,93,23,94],"AMCI","Slow wave sleep","Cognition","2026-06-15",{"date":97,"type":98},"2026-06-17","ACTUAL",{"date":100,"type":98},"2023-02-02",{"date":102,"type":83},"2028-06-30",{"name":5,"class":6},1]