Life's End Benefits of cannaBidiol and tetrahYdrocannabinol (LiBBY)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
The Neuron Clinic
NOT_YET_RECRUITING
Chula Vista
Sun Valley Research Center
RECRUITING
Imperial
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Howard University
RECRUITING
Washington D.c.
Florida
Melgar-Caro Medcenter and Community Research (MCMCR)
RECRUITING
Miami
University of South Florida
RECRUITING
Tampa
Kentucky
University of Kentucky
RECRUITING
Lexington
Louisiana
Pennington Biomedical Research Center
RECRUITING
Baton Rouge
Maryland
University of Maryland
RECRUITING
Baltimore
Ohio
Case Western Reserve University
RECRUITING
Beachwood
South Carolina
Ralph H. Johnson VA Medical Center
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center Center for Cognitive Medicine
RECRUITING
Nashville
Texas
Baylor Scott & White AT&T Medical Center
WITHDRAWN
Dallas
Contact Information
Primary
ATRI Recruitment Unit
libby-participate@usc.edu
213-821-0569
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2025-12
Participants
Target number of participants: 120
Treatments
Experimental: T2:C100
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of South Carolina, Alzheimer's Clinical Trials Consortium, Alzheimer's Therapeutic Research Institute, National Institute on Aging (NIA)
Leads: University of Southern California

This content was sourced from clinicaltrials.gov