[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"agitationpsychomotor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:agitationpsychomotor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,60,88,116,140],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100481029","phase-2-clinical-trial-on-agitation-in-alzheimers-dementia-100481029",false,"NCT05543681","Clinical Trial on Agitation in Alzheimer's Dementia","A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants With Dementia Due to Alzheimer's Disease","CALMA","To be eligible to participate in this study, the participant must meet all the following criteria:\n\nInclusion Criteria\n\n1. Participant and\u002For Caregiver must provide a signed and dated ICF prior to any study procedures.\n2. Must have a Caregiver who is able and willing to comply with all required study procedures.\n3. The Caregiver must be known to the Participant and must be able to use electronic devices such as a cell phone, video conference over a laptop or cell phone, weighing scale, and be able to learn to take blood pressure, among others.\n4. Based on local practice, Participants that cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney, b) is a spouse, or c) a sibling or d) a child or e) a close relation. The practice of accepting consent must be consistent with established practice at the site and jurisdiction.\n5. Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.\n6. Diagnosis of AD by NIA-AA criteria\n7. Clinically significant Agitation assessed by:\n\n   1. NPI (Agitation) ≥ 4\n   2. The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and\n   3. Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.\n8. Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.\n9. All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.\n10. Women must be of no childbearing potential (postmenopausal, defined as cessation of menses for at least 12 months, without an alternative medical cause for amenorrhea) or surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)).\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nExclusion Criteria\n\n1. Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).\n2. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.\n3. History of seizures, schizophrenia, or bipolar disorder.\n4. Has participated in an investigational drug or device study within 30 days prior to study start.\n5. Urine drug screen positive for drug use, except for benzodiazepines if Participant was using them previously and their dose had remained stable for at least six weeks before screening.\n6. History of Alcohol and Drug use disorder, within one year prior to enrollment.\n7. Hypertension: Participants with a history of uncontrolled hypertension as determined by the PI and Participants with a hypertensive crisis in the six months prior to enrollment.\n8. Falls: Participants with a history of recurrent falls defined as more than two falls in the six-month period prior to enrollment and a history of falls resulting in injuries or associated with a new acute illness, loss of consciousness, fever, or abnormal blood pressure (Fuller et al., 2000).","ALL","60 Years",{"count":20,"type":21},164,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.",[27,28,29,30,31],"Alzheimer Disease","Agitation,Psychomotor","Care Giving Burden","NPS","Aggression",[33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Cannabis","Tetrahydrocannabinol","THC","Melatonin","Alzheimer's","Marijuana","Hemp","Agitation","Dementia","Depression","Anxiety","NPI","CMAI","Dronabinol","RECRUITING","2026-05-18",{"date":50,"type":51},"2026-05-20","ACTUAL",{"date":53,"type":51},"2022-10-11",{"date":55,"type":21},"2026-08",{"name":57,"class":58},"IGC Pharma, LLC","INDUSTRY",31,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":5},"100356862","electroconvulsive-therapy-ect-for-agitation-in-dementia-ad-100356862","NCT03926520","Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)","Effect and Safety of Electroconvulsive Therapy Plus Usual Care for the Acute Management of Severe Agitation in Dementia","ECT-AD","Inclusion Criteria\n\n1. Diagnosis of Dementia, of the following subtypes,\n\n   1. Alzheimer's dementia, according to NIA-AA Criteria for dementia\n   2. Vascular dementia based on:\n\n   i. History consistent with insidious onset of illness and gradual clinical decline ii. MRI evidence of microvascular ischemic disease (microinfarcts) iii. Physical and neurological examination do not indicate current or prior stroke c. Frontotemporal dementia d. Dementia with Lewy Bodies\n2. Mini Mental Status Exam (MMSE) less than or equal to 15\n3. Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of 5 or more on at least one item or score of 4 on two items of aggression or physical nonaggression that holds potentially dangerous consequences including hitting (including self), kicking, grabbing onto people, pushing, throwing things, biting, scratching, spitting, hurting self or other, tearing things or destroying property, making physical sexual advances, trying to get to a different place, or intentional falling (items 1-11, 14, 15) OR one score of 5 or more in items of verbal aggression including screaming, making verbal sexual advances, and cursing or verbal aggression (items 22-24).\n4. At least one failed pharmacological intervention to manage behavioral symptoms\n5. Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries and brain imaging when clinically indicated\n6. Comprehension of English language\n7. Authorized legal representative able and willing to give informed consent\n8. Age 40 and above\n\nExclusion Criteria:\n\n1. Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Measure (CAM) and by clinical diagnosis\n2. Diagnosis of vascular dementia due to stroke, based on:\n\n   * History consistent with abrupt onset and step-wise progression of cognitive and functional decline\n   * MRI scan within the past 12 months demonstrating evidence of hemorrhagic and embolic stroke\n   * Physical and neurologic examination consistent with current or prior stroke\n3. Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder\n4. Active substance use disorder within past 6 months\n5. Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months","40 Years",{"count":70,"type":21},50,[72],"NA","This study will explore the effect of ECT treatments plus usual care (ECT+UC) in reducing severe agitation in patients with moderate to severe dementia including Alzheimer's Disease, Vascular dementia, Frontotemporal dementia, and Dementia with Lewy Bodies. The study will also determine the tolerability\u002Fsafety outcomes of ECT+UC.",[75,28],"Alzheimer Dementia",[77,40,37,41],"ECT","2026-04-24",{"date":80,"type":51},"2026-04-28",{"date":82,"type":51},"2021-01-28",{"date":84,"type":21},"2026-05-31",{"name":86,"class":87},"Brent Forester","OTHER",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"100499457","a-multicomponent-intervention-program-to-prevent-and-reduce-icu-agitation-and-physical-restraint-use-100499457","NCT05783505","A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use","PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention","PRAISE","Inclusion criteria:\n\n* Adult ICU patients (aged ≥18) with an expected ICU stay of \\>24 hours\n* Patients who are (expected to become) agitated within the first 14 days of their ICU admission\n\nExclusion criteria:\n\n* Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known\u002Fsuspected hypersensitivity);\n* Neurological patients with an (expected risk of) increased intracranial pressure;\n* An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);\n* Support with Extracorporeal Membrane Oxygenation (ECMO);\n* Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);\n* A high risk of physical aggression towards healthcare professionals;\n* No consent for long term follow up in the MONITOR-IC study;\n* Not able to read or understand the Dutch language and no relatives able to assist;\n* Enrolment in other sedation studies.","18 Years",{"count":98,"type":21},480,[72],"Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.",[28],[103,40,104,105,106],"ICU","Physical Restraints","Non-pharmacologic interventions","Dexmedetomidine","2025-06-12",{"date":109,"type":51},"2025-06-17",{"date":111,"type":51},"2023-06-01",{"date":113,"type":21},"2026-10-01",{"name":115,"class":87},"Radboud University Medical Center",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100563763","phase-2-effects-of-dexmedetomidine-on-agitation-in-critically-ill-tbi-patients-100563763","NCT06620393","Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients","Effects of Dexmedetomidine on Agitation in Critically Ill TBI Patients (DEX-TBI)","DEX-TBI","Inclusion Criteria:\n\n1. Adults (≥18 years) admitted to ICU with a critically ill moderate or severe TBI patients. Severity of TBI will be determined with the first Glasgow Coma Score (GCS). TBI patients with polytrauma and patients undergoing neurosurgical interventions will be eligible.\n2. Undergoing mechanically ventilation (of any duration) at the time of assessment.\n3. Anticipated ICU stay of 48 hours or more.\n\nExclusion Criteria:\n\n1. Patients at very high risk of short-term mortality (e.g., GCS of 3 without sedation, or unreactive pupils, or declared brain-dead when assessed for eligibility and patients in whom there is a lack of commitment to ongoing life support\n2. Patients unable to communicate in English or French (interfering with posttraumatic amnesia assessments)\n3. Patients with cognitive impairment as per family evaluation\n4. Pregnant or breastfeeding\n5. Patients currently receiving DEX or clonidine\n6. Allergy, bradycardia or hypotension precluding use of dexmedetomidine as per treating physician",{"count":125,"type":21},72,[24,127],"PHASE3","Agitation is a frequent complication following traumatic braing injury in patients admitted to the intensive care unit. This agitation frequently results in the liberal use of rescue drugs such as antipsychotics, sedatives and opiates, which in turn may delay rehabilitation, liberation from mechanical ventilation and emergence from posttraumatic amnesia. Dexmedetomidine may be a better agent given it's light sedative properties. The main objective is to assess the feasibility of conducting a multicenter randomized controlled trial of dexmedetomidine following TBI in the ICU.",[130,28],"Traumatic Brain Injury","NOT_YET_RECRUITING","2024-09-27",{"date":134,"type":51},"2024-10-01",{"date":134,"type":21},{"date":137,"type":21},"2026-12-01",{"name":139,"class":87},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":17,"minAge":96,"maxAge":149,"enrollmentInfo":150,"targetDuration":152,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100498046","safe-brain-initiative-operationalizing-precision-anaesthesia-100498046","NCT05765162","Safe Brain Initiative, Operationalizing Precision Anaesthesia","Safe Brain Initiative - Dedicated to Advancing Anaesthesia and Perioperative Personalised Care Towards Precision Anaesthesia Care. A Continuous Quality Improvement Initiative.","SBI","Inclusion Criteria:\n\n• All patients from age ≥18\n\nExclusion Criteria:\n\n• All patients from age \\\u003C18",true,"100 Years",{"count":151,"type":21},15000,"5 Years","OBSERVATIONAL","Perioperatively, patients experience an unnecessarily high level of side effects associated with their treatment. These side effects include nausea, severe pain, anxiety, and stress. Moreover, many patients develop postoperative delirium (POD) and neurocognitive dysfunctions, often resulting in long-term cognitive impairment, decreased quality of life, and increased mortality. However, physicians, nurses and their institutions do not receive structured feedback regarding these aspects of each patient's well-being. They may therefore be unable to engage in the essential cause-and-effect learning necessary to evaluate and consecutively reduce such side effects.\n\nEffective guidelines conform prevention is the proven key to shielding our patients from adverse Outcomes. The Safe Brain Initiative's high-quality routine data-for-action is a sword and accelerator for moving towards patient-centred, precision care. Thus, establishing a foundation for value-based and patient-centred healthcare development.\n\nHowever, a turnkey real-world solution is challenging to develop and implement and requires substantial resources. As a result, such solutions are usually beyond the scope of a single institution. The SBI platform provides high-quality, real-world data to bridge this gap. It allows monitoring and in-depth analysis of cause and effect in the day-to-day routine of individuals, departments, and institutions.\n\nThe SBI's approach is continuously improved and updated. An organization called the SBI Global Society oversees the quality and precision of science through experts in the field. At SBI Hospitals and Flagship centres, Masterclasses are conducted and can be attended alongside clinical immersions.\n\nSBI Solutions manages, develops, and provides technical and service support for the Safe Brain Initiative. Its service guarantees the professional and GDPR conform management of data handling and storage as well as the user-friendly functionality of the SBI-Dashboard solutions.",[156,157,158,159,160,161,162,43,163,28,164,165,166,167,168,169,170],"Neurocognitive Disorders","Post Operative Delirium","Pain","Nausea","Vomiting","Wellbeing","Shivering","Stress","Sedation Complication","Thirst","Satisfaction, Patient","Temperature Change, Body","Fasting","Sore-throat","Hearing and Vision Loss","2024-06-05",{"date":173,"type":51},"2024-06-07",{"date":175,"type":51},"2021-12-01",{"date":177,"type":21},"2026-01-01",{"name":179,"class":87},"University of Southern Denmark",1]