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Phase 2

Cannabidiol & Tetrahydrocannabinol

Sponsor:

University of Southern California

Code:

NCT05644262

Conditions

Agitation

Dementia

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

T2:C100

Placebo

Study Details

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 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.

Conditions

Agitation

Dementia

Study ID

NCT05644262

Start date

Dec 18, 2023

Status verified date

Oct, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: T2:C100

placebo comparator: Placebo

Interventions

T2:C100

The active study intervention, T2:C100, is an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in a digestible oil. T2:C100 is a full spectrum oral solution with five non-reactive ingredients: delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), a pharmaceutical grade medium chain triglyceride (MCT) oil, and two flavoring agents (lemon and peppermint).

During the double-blind treatment period, participants will receive 1mL study drug (T2:C100) twice daily for Baseline - Day 7 (approximately 1 week), and then will increase to 2mL study drug twice for the remainder of the double-blind treatment period (Day 7 - Week 12 (approximately 11 weeks)).

Participants who enter the Open Label Extension will receive 1mL study drug (T2:C100) twice daily for Week 12 - Week 13 (approximately 1 week), and will then increase to 2mL study drug twice daily for the remainder of the Open Label Extension (Week 13 - Week 26 (approximately 23 weeks)).

Placebo

Matching placebo in a digestible oil. The placebo contains only three non-reactive ingredients: medium chain triglyceride (MCT) oil and two flavoring agents (lemon and peppermint).

During the double-blind treatment period, participants will receive 1mL placebo twice daily for Baseline - Day 7 (approximately 1 week), and then will increase to 2mL placebo twice for the remainder of the double-blind treatment period (Day 7 - Week 12 (approximately 11 weeks)).

Primary outcome measure

  • Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks [ Time Frame: Baseline, Day 7 and Day 14 ]

Central Contacts and Locations

Central contacts

Locations

Sun Valley Research Center

Recruiting

Imperial, California, United States, 92251

Contacts

Principal Investigator:

Bernardo Ng, MD

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Alison Perlberg

ap2157@georgetown.edu

Principal Investigator:

Melanie Chadwick, MSN, APRN, GNP

Howard University

Recruiting

Washington D.C., District of Columbia, United States, 20059

Contacts

Principal Investigator:

Thomas Obisesan, MD

Melgar-Caro Medcenter and Community Research (MCMCR)

Recruiting

Miami, Florida, United States, 33145

Contacts

Alejandro Amador Gonzalez

crcamador@mcmcr.net

Principal Investigator:

Rinaldo Caro-Sanchez, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Dusan Nikolic-Dorschel

727-488-4826nikolic@usf.edu

Mark Kindy, PhD

kindym@usf.edu

Principal Investigator:

Mark Kindy, PhD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40504

Contacts

Principal Investigator:

Gregory Jicha, MD, PhD

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Principal Investigator:

Jeffrey Keller, PhD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Raya Kheirbek, MD, MPH

Case Western Reserve University

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Principal Investigator:

Rajeet Shrestha, MD

Ralph H. Johnson VA Medical Center

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Principal Investigator:

Olga Brawman-Mintzer, MD

Vanderbilt University Medical Center Center for Cognitive Medicine

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Principal Investigator:

Patricia Andrews, MD

More Information

Sponsor

University of Southern California

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Keywords

  • agitation
  • hospice care-eligible
  • dementia
  • agitation and dementia (HAD)
  • alzheimer's disease
  • alzheimer's disease dementia
  • alzheimer's disease and related dementias

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.