Life's End Benefits of cannaBidiol and tetrahYdrocannabinol (NCT05644262) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
United States120 participantsStarted 2023-12-18
Plain-language summary
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.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
ā. Provision of signed and dated informed consent from participant or legally authorized representative.
ā. Person of any sex/gender 40 years of age or older.
ā. Ability to take or be administered liquid medication.
ā. Meets DSM-V criteria for Major Neurocognitive Disorder.
ā. Current clinically significant agitation as demonstrated by an NPI-agitation subscale of 4 or above at Screening.
ā. Meets at least one of the following requirements:
ā. Currently enrolled in out-patient or in-patient hospice care.
ā. Stage 6d on the Functional Assessment Staging Test (FAST).
Exclusion criteria
ā. Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, as based on self-report.
ā. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to cannabinoids and/or components (e.g., (\<specify oil to be used in final formulation, e.g.: coconut oil; sesame oil\>) of the study drug (T2:C100 or placebo).
What they're measuring
1
Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks
ā. 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.
ā. 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.