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NCT05644262 | RECRUITING | Agitation

Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
Sponsor:

University of Southern California

Information provided by (Responsible Party):

Paul S. Aisen

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.

Condition or disease

Agitation

Dementia

Intervention/treatment

T2:C100

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Life's End Benefits of cannaBidiol and tetrahYdrocannabinol (LiBBY)
Actual Study Start Date : 2023-12-18
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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., (\) 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.
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

Location Details

NCT05644262

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

The Neuron Clinic

Chula Vista, California, United States, 91910

NOT YET RECRUITING

United States, California

Sun Valley Research Center

Imperial, California, United States, 92251

RECRUITING

United States, District of Columbia

Georgetown University

Washington, District of Columbia, United States, 20007

RECRUITING

United States, District of Columbia

Howard University

Washington, District of Columbia, United States, 20059

RECRUITING

United States, Florida

MCMCR

Miami, Florida, United States, 33145

RECRUITING

United States, Florida

University of South Florida

Tampa, Florida, United States, 33612

RECRUITING

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40504

RECRUITING

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

RECRUITING

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

RECRUITING

United States, Ohio

Case Western Reserve University

Beachwood, Ohio, United States, 44122

RECRUITING

United States, South Carolina

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States, 29401

RECRUITING

United States, Tennessee

Vanderbilt University Medical Center Center for Cognitive Medicine

Nashville, Tennessee, United States, 37212

NOT YET RECRUITING

United States, Texas

Baylor Scott & White AT&T Medical Center

Dallas, Texas, United States, 75231