Life's End Benefits of CannaBidiol and TetrahYdrocannabinol

Last updated: February 28, 2025
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Manic Disorders

Williams Syndrome

Treatment

T2:C100

Placebo

Clinical Study ID

NCT05644262
ATRI-007
5R01AG068324-03
  • Ages > 40
  • All Genders

Study 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

Inclusion Criteria:

  1. Provision of signed and dated informed consent from participant or legallyauthorized 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-agitationsubscale of 4 or above at Screening.

  6. Meets at least one of the following requirements:

  7. Currently enrolled in out-patient or in-patient hospice care.

  8. Stage 6d on the Functional Assessment Staging Test (FAST).

  9. Score of 12 or more according to the Advanced Dementia Prognostic Tool (ADEPT)as implemented by the Mitchell Index.

  10. Willing to agree not to use cannabinoids in any form (e.g., topically applied,ingested, inhaled, or other form of administration), other than the trialmedication, during the first 12 weeks of the study.

  11. Has a third-party clinician (e.g., hospice, palliative care, PCP) who is responsiblefor medical management of the participant outside the study.

  12. In the opinion of the investigator, resides in an environment suitable to conduct aclinical trial (i.e., study intervention can be administered and concomitantmedication use can be accurately documented).

  13. 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 theadministration of study drug, and participate in study visits and informant-basedassessments (usually requires at least 5 hours of contact per week). NOTE: Other knowledgeable informants/informed caregivers may contribute toinformant-based scales; however, the site should identify an informant who will beable to serve as the primary source of information.

  14. As assessed by investigator, participant is likely to be able to comply with theprotocol for a minimum of 2 weeks.

Exclusion

Exclusion Criteria:

  1. Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, asbased on self-report.

  2. Suspected or known allergic reactions, adverse reactions, or hypersensitivity tocannabinoids and/or components (e.g., () of the study drug (T2:C100 or placebo).

  3. Treatment with another investigational drug or other investigational interventionwithin 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 unsuitablefor inclusion.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: T2:C100
Phase: 2
Study Start date:
December 18, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • The Neuron Clinic

    Chula Vista, California 91910
    United States

    Site Not Available

  • Sun Valley Research Center

    Imperial, California 92251
    United States

    Site Not Available

  • The Neuron Clinic

    San Marcos, California 92069
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Howard University

    Washington, District of Columbia 20059
    United States

    Site Not Available

  • Galiz Research

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Melgar-Caro Medcenter and Community Research (MCMCR)

    Miami, Florida 33145
    United States

    Active - Recruiting

  • James A. Haley Veterans' Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40504
    United States

    Active - Recruiting

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Case Western Reserve University

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina 29401
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

  • Baylor Scott & White AT&T Medical Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Washington SBICR

    Seattle, Washington 98108
    United States

    Site Not Available

  • University of Washington SIBCR / VA Puget Sound

    Seattle, Washington 98108
    United States

    Site Not Available

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