Life's End Benefits of cannaBidiol and tetrahYdrocannabinol (LiBBY)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks
研究概览
简要总结
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks.
This study will enroll approximately 120 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo.
The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent from participant or legally authorized representative.
- •Person of any sex/gender 40 years of age or older.
- •Ability to take or be administered liquid medication.
- •Meets DSM-V criteria for Major Neurocognitive Disorder.
- •Current clinically significant agitation as demonstrated by an NPI-agitation subscale of 4 or above at Screening.
- •Meets at least one of the following requirements:
- •Currently enrolled in out-patient or in-patient hospice care.
- •Stage 6d on the Functional Assessment Staging Test (FAST).
- •Score of 12 or more according to the Advanced Dementia Prognostic Tool (ADEPT) as implemented by the Mitchell Index.
- •Willing to agree not to use cannabinoids in any form (e.g., topically applied, ingested, inhaled, or other form of administration), other than the trial medication, during the first 12 weeks of the study.
- •Has a third-party clinician (e.g., hospice, palliative care, PCP) who is responsible for medical management of the participant outside the study.
- •In the opinion of the investigator, resides in an environment suitable to conduct a clinical trial (i.e., study intervention can be administered and concomitant medication use can be accurately documented).
- •In the opinion of the site PI, has a study partner (may be paid or unpaid caregiver) able and willing to provide accurate information about the participant, oversee the administration of study drug, and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week).
- •NOTE: Other knowledgeable informants/informed caregivers may contribute to informant-based scales; however, the site should identify an informant who will be able to serve as the primary source of information.
- •As assessed by investigator, participant is likely to be able to comply with the protocol for a minimum of 2 weeks.
排除标准
- •Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, as based on self-report.
- •Suspected or known allergic reactions, adverse reactions, or hypersensitivity to cannabinoids and/or components (e.g., () of the study drug (T2:C100 or placebo).
- •Treatment with another investigational drug or other investigational intervention within the previous 30 days or five half-lives of the investigational product, whichever is longer.
- •Any condition, which in the opinion of the site PI, Data and Coordinating Center, regulatory sponsor, or Project Lead/Protocol PI, makes the participant unsuitable for inclusion.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
T2:C100
干预措施: T2:C100 (Drug)
结局指标
主要结局
Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks
时间窗: Baseline, Day 7 and Day 14
The Cohen-Mansfield Agitation Inventory (CMAI) assesses the average frequency of manifestations of agitated behaviors in elderly persons over a 1-week period. The CMAI is a questionnaire consisting of 29 agitated behaviors, each rated on a 7-point frequency scale. In addition to the frequency of each behavior, informants/caregivers will be asked to use a 5-point scale to rate the disruptiveness of each behavior. For this study, the CMAI will target behaviors observed by knowledgeable informants/informed caregivers. Expanded descriptions of the behaviors will be provided to the informant/caregiver to be used as a reference during the interview.
次要结局
- Clinical Global Impression of Change in Behavior (CGIC-B)(Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12)
- Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 12 weeks(Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12)
- Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 12 weeks(Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12)
研究者
Paul S. Aisen
Professor
University of Southern California