NCT06217146终止不适用
A Two-part Study, Part I an Open-label; and Part II a Randomized Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MediCane's Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia Including Probable Alzheimer's Disease (AD)
M. H MediCane Ltd.3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年10月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Part 2 Efficacy (CMAI)
研究概览
简要总结
This double-blind, placebo-controlled study is designed to assess the effectiveness of, MediCane's medical cannabis oil extracted from MediCane's proprietary strain into GMP-grade olive oil, as an add-on therapy to standard of care (SoC), in reducing agitation and disruptive behaviors in subjects with dementia including probable AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are Male or Female age ≥50 years.
- •Subjects have a diagnosis of major neurocognitive disorder (previously dementia) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria for at least 6 months prior to screening or a diagnosis of probable AD using the NINCDS-ADRDA clinical criteria.
- •Subjects on antipsychotic medications may be included in the study.
- •Subject exhibits agitation/aggression with a Neuropsychiatric Inventory (NPI-12)-agitation/aggression subdomain score of four or higher (≥4) at screening.
- •Subject has a legal guardian who is able and willing to provide ICF and able to provide - information in writing. The caregiver should be spending enough time with the subject on a regular basis in order to provide valid information as requested.
- •Subjects are on stable SoC for treatment of agitation and disruptive behaviors for at least 2 weeks prior to the screening visit.
- •Subjects on Acetyl Choline Esterase inhibitors, antifungals, macrolide antibiotics and anti-hypertensive therapy including ACE inhibitors should be on stable doses for at least 2 weeks prior to screening visit or if changed, at least 2 weeks prior to visit
- •Subject's Mini Mental State Exam score (MMSE) is 24 or less at screening.
排除标准
- •Subject without a legal guardian.
- •Subject with any current unstable medical condition.
- •Subject has any unstable condition involving fluid retention, pulmonary infiltrates, congestive heart failure, respiratory symptoms or disease, or cardiac symptoms or disease.
- •Subject has one of the following hepatic /renal disorders:
- •Confirmed and unexplained impaired hepatic function as indicated by screening AST or ALT>3 the upper limit of normal (ULN) or total bilirubin > 2 ULN.
- •Chronic kidney disease of Stage > 4, according to National Kidney Foundation Kidney Disease Outcome Quality Initiative guidelines for chronic kidney disease.
- •Subject has epilepsy.
- •Subject has a history of hypersensitivity to any cannabinoid.
- •Subject has the presence or history of a primary psychotic psychiatric disorder or subject has clinically significant delusions or hallucinations secondary to the neurodegenerative disease (NPI-12 delusions or hallucinations sub-score of 4 or higher (≥4).
- •Subject suffering from delirium as defined in Appendix B - Criteria for Delirium.
- •Current inpatient hospitalization.
- •Subject has other health-related factors that could explain behavioral disturbances (electrolyte disturbances, infectious diseases, etc.).
- •Subject has a satisfactory response to antipsychotic treatments.
- •Subjects treated with one of the following medications: opiates, primidone, phenobarbitol, carbamazepine, rifampicin, rifabutin, troglitazone, hypericum perforatum, or valproic acid within 30 days from Visit
- •Subjects currently on medication known to interact with Cannabis-based medications are excluded; Subjects taking Cannabis-based therapies are excluded if within the past 2 weeks from Visit
- •Subjects with a history of addiction or drug abuse.
研究组 & 干预措施
MediCane's medical cannabis oil
Experimental
干预措施: Medical Cannabis (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Oil (Drug)
结局指标
主要结局
Part 2 Efficacy (CMAI)
时间窗: 12 weeks
Change in agitation and aggression from baseline to Week 12 as measured using the Cohen-Mansfield Agitation Inventory-Community (CMAI-C), a 37-item scale that measures the types and frequencies of agitated behaviors, each rated on a 7-point scale of frequency, where higher scores indicate greater agitation severity.
Part 1 Safety (Adverse Events)
时间窗: Up to 22 weeks
Number of participants with treatment-related adverse events as assessed by severity. protocol.
次要结局
- Part 1 Efficacy (NPI-12)(up to 18 weeks)
研究者
研究点 (3)
Loading locations...
相似试验
终止
1 期
Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid TumorsSolid Tumor, AdultNCT05307874ImCheck Therapeutics, an Ipsen company56
尚未招募
2 期
A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian CancerOvarian CancerNCT06211023Suzhou Suncadia Biopharmaceuticals Co., Ltd.520
终止
2 期
PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706Early Parkinson DiseaseNCT03655236Sun Pharma Advanced Research Company Limited513
终止
2 期
Study to Evaluate the Efficacy and Safety of Maraviroc in SARS-CoV-2 Infection (COVID-19).COVID-19NCT04441385Hospital Universitario Infanta Leonor60
已完成
2 期
A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCCNCT04948697BeiGene94