[{"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":28},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100395975","phase-2-effects-of-thc-free-cbd-oil-on-agitation-in-patients-with-alzheimers-disease-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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Alzheimer Disease","Dementia","Major Neurocognitive Disorder With Aggressive Behavior",[30,31,32,33,34,35,36,37,38,39,40],"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":44,"type":45},"2023-02-16","ACTUAL",{"date":47,"type":45},"2021-02-26",{"date":49,"type":20},"2024-03",{"name":51,"class":52},"Eastern Virginia Medical School","OTHER"]