Randomized Double-blind Cross-over Placebo-controlled Trial to Study the Impact on Behavioral and Psychological Symptoms of Dementia of Medical Cannabinoids (CBD/THC) in Patients with Severe Dementia in Long-term Care Facilities in Geneva
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Cohen-Mansfield Agitation Inventory Scale (CMAI)
研究概览
简要总结
The behavioral and psychological symptoms of dementia affect up to 80% of long-term facilities residents with severe dementia. They seriously alter the quality of life of patients, relatives, and health professionals. Management involves correcting somatic and psychiatric factors and implementing non-drug interventions. Nevertheless, often drug treatments must be introduced with the limitations related to their effectiveness and adverse effects.
The investigators hypothesize that medical cannabinoids will improve neuropsychiatric and behavioral symptoms of patients with severe dementia.
The investigators assessed the feasibility and safety of administering a cannabis oil that contains tetrahydrocannabinol (THC) and Cannabidiol (CBD) during an initial study of about two years, observing an overall improvement, excellent tolerance to the treatment, and the possibility of reducing or even stopping other drugs.
This research project aims to study the efficacy of medical cannabis oil in improving the quality of life of dementia patients experimenting with behavioral and psychological symptoms.
详细描述
The study design is a placebo-controlled cross-over trial. The patients, the relatives, the health care professionals, and the study staff will be blinded.
Medical cannabis treatment is a cannabis oil that contains THC and CBD in a 1:2 ratio. The initial dose of 7 drops (2.5 mg THC and 5 mg CBD) will be gradually augmented and adjusted individually to a maximum of 56 drops (20 mg THC and 40 mg CBD) per day, divided into two administrations. Placebo is an edible oil with the same color, smell, and flavor as medical cannabis oil given with the same dosage scheme.
Patients will take medical cannabis oil for 8 weeks, in addition to their usual treatments.
The study is divided into two 8-week periods. Participants will be randomized 1:1 between cannabinoids/placebo and placebo/ cannabinoids sequences and will receive the cannabis oil during one of these periods and the placebo during the other.
Participants will observe a wash-out week between the two study periods, and a final observation week without treatment intake is planned at the end of the second period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe dementia from different origins (Alzheimer's disease, vascular, mixed)
- •Clinical Dementia Rating ≥3
- •Persisting behavior problems (Neuropsychiatric Inventory [NPI] score > 10) notwithstanding optimal conventional treatment
- •SARS-CoV-2 recovered for two weeks, or SARS-CoV-2 fully vaccinated
- •Consent obtained from the representative in the medical field according to art 378 Swiss Civil Code (SCC)
排除标准
- •Severe organ deficiency such as cardiac, pulmonary, hepatic, renal insufficiency, or unstable heart rhythm
- •Symptomatic orthostatic hypotension
- •Major changes or instability of psychotropic medication in the week preceding the study enrolment
- •Having taken THC and/or CBD in the 7 days before enrolment
- •Hemoglobin < 10 g/dl
- •Severe kidney failure defined by cockcroft calculation <30 ml/mn
- •Alanine aminotransferase and aspartate aminotransferase > 3x upper limit of normal
- •Any other medical conditions that would prevent participation in the whole study protocol.
研究组 & 干预措施
Cannabis Sativa Oil first, then Placebo
This arm will start with the active comparator for the first period and change to the placebo in the second period
干预措施: Cannabis Sativa Oil (Drug)
Cannabis Sativa Oil first, then Placebo
This arm will start with the active comparator for the first period and change to the placebo in the second period
干预措施: Placebo (Drug)
Placebo first, then Cannabis Sativa Oil
This arm will start with the placebo for the first period and change to the active comparator in the second period
干预措施: Cannabis Sativa Oil (Drug)
Placebo first, then Cannabis Sativa Oil
This arm will start with the placebo for the first period and change to the active comparator in the second period
干预措施: Placebo (Drug)
结局指标
主要结局
Cohen-Mansfield Agitation Inventory Scale (CMAI)
时间窗: 4 and 8 weeks - after 1 week washout
Change from baseline in the Cohen-Mansfield Agitation Inventory score. Scores range from 29 to 203 - higher scores mean a worse outcome ( A total score \>45 is usually regarded as clinically significant agitation).
次要结局
- Pain (Doloplus)(4 and 8 weeks - after 1 week wash-out)
- Family(4 and 8 weeks - after 1 week wash-out)
- Evolution of dosages for each patient(4 and 8 weeks)
- Change in enzymatic activity(8 weeks)
- Daily activity(4 and 8 weeks - after 1 week wash-out)
- Neuropsychiatric Inventory (NPI)(4 and 8 weeks - after 1 week wash-out)
- Unified Parkinson disease rigidity scale (UPDRS)(4 and 8 weeks - after 1 week wash-out)
- Therapeutic Drug Monitoring(8 weeks)
- Behavioral Trouble(4 and 8 weeks - after 1 week wash-out)
- Endocannabinoids(8 weeks)
- Team(4 and 8 weeks - after 1 week wash-out)