[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-neurocognitive-disorder-with-aggressive-behavior\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-neurocognitive-disorder-with-aggressive-behavior":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100395975",false,"NCT04436081","Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer's Disease","Inclusion Criteria:\n\n* Males\u002Ffemales over 50 years old.\n* Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.\n* A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive.\n* Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation\u002Faggression subscore \\> 3.\n* Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent.\n* For patients treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEI) and\u002For memantine), the dosage must be stable for at least 1 month (30 days). If the ChEI and\u002For memantine has been discontinued, patients may enroll after 15 days.\n* Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them.\n\nExclusion Criteria:\n\n* Diagnosis of non-AD or non-mixed dementias.\n* Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4).\n* NPI-agitation-aggression score \\\u003C 3.\n* Having a serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease which might confound assessment of safety outcomes as determined by the study physician.\n* Presence or history of other serious psychiatric disorders or neurological conditions (e.g. psychotic disorders, bipolar disorder or schizophrenia).\n* Current abuse of\u002Fdependence on marijuana, current drug abuse, current alcohol abuse.\n* Having seizure disorders.\n* Pregnant or breastfeeding\n* Indication of baseline delirium as determined by the Confusion Assessment Method (CAM).\n* Current use of lithium.\n* Inability to swallow CBD oil softgels.\n* Changes in dosage of anti-depressives within 4 weeks before randomization and during the study.\n* Changes in dosage of antipsychotics or benzodiazepines within 1 week prior to randomization and during the study.\n* Contraindications to CBD oil (history of hypersensitivity to any cannabinoid).\n* Frequent falling due to orthostatic hypotension.\n* Use of tricyclic antidepressants (TCA), fluoxetine, and\u002For carbamazepine. -Patients who reside in nursing homes.","ALL","50 Years","90 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants' quality of life.",[25,26,27],"Alzheimer Disease","Dementia","Major Neurocognitive Disorder With Aggressive Behavior",[29,30,31,32,33,34,35,36,37,38,39],"Agitation","Aggression","Neuropsychiatric symptoms","CBD Oil","Cannabinoids","Caregiver burden","Sleep quality","Behavioral and Psychological Symptoms of Dementia","Neurocognitive disorders","Psychomotor agitation","Cannabidiols","RECRUITING","2023-02-15",{"date":43,"type":44},"2023-02-16","ACTUAL",{"date":46,"type":44},"2021-02-26",{"date":48,"type":19},"2024-03",{"name":50,"class":51},"Eastern Virginia Medical School","OTHER",""]