Clinical trial NCT05644262: Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
Official title: Life's End Benefits of cannaBidiol and tetrahYdrocannabinol (LiBBY)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Agitation
Dementia
Keywords: agitation
hospice care-eligible
dementia
agitation and dementia (HAD)
alzheimer's disease
alzheimer's disease dementia
alzheimer's disease and related dementias
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Alzheimer's Clinical Trials Consortium
name: Alzheimer's Therapeutic Research Institute
name: National Institute on Aging (NIA)
First posted: 2022-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 150 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.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent from participant or legally authorized representative.
2. Person of any sex/gender 40 years of age or older.
3. Ability to take or be administered liquid medication.
4. Meets DSM-V criteria for Major Neurocognitive Disorder.
5. Current clinically significant agitation as demonstrated by an NPI-agitation subscale of 4 or above at Screening.
6. Meets at least one of the following requirements:

   1. Currently enrolled in out-patient or in-patient hospice care.
   2. Stage 6d on the Functional Assessment Staging Test (FAST).
   3. Score of 12 or more according to the Advanced Dementia Prognostic Tool (ADEPT) as implemented by the Mitchell Index.
7. 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.
8. Has a third-party clinician (e.g., hospice, palliative care, PCP) who is responsible for medical management of the participant outside the study.
9. 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).
10. 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.
11. As assessed by investigator, participant is likely to be able to comply with the protocol for a minimum of 2 weeks.

Exclusion Criteria:

1. Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, as based on self-report.
2. 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).
3. 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.
4. 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.

Primary outcomes:
measure: Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks
timeFrame: Baseline, Day 7 and Day 14
Secondary outcomes:
measure: Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 12 weeks
timeFrame: Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12
measure: Clinical Global Impression of Change - agitation (CGICa)
timeFrame: Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: The Neuron Clinic
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Miami
country: United States
facility: Melgar-Caro Medcenter and Community Research (MCMCR)
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Beachwood
country: United States
facility: Case Western Reserve University
state: Ohio
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Center for Cognitive Medicine
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White AT&T Medical Center
state: Texas
Study officials:
affiliation: Alzheimer's Therapeutic Research Institute
name: Paul Aisen, MD
role: STUDY_DIRECTOR
affiliation: Ralph H. Johnson Veterans Affairs Medical Center (VAMC)
name: Jacobo Mintzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University
name: Brigid Reynolds, NP
role: PRINCIPAL_INVESTIGATOR
References: