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Effects of THC and CBD on agitation in dementia patients

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

Phase 2 Interventional University of Southern California · NCT05644262

This study is testing if a combination of THC and CBD can help reduce agitation in older patients with dementia who are in hospice care.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages40 Years and up
SexAll
SponsorUniversity of Southern California Academic / other
Locations13 sites (Chula Vista, California and 12 other locations)
Trial IDNCT05644262 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase 2 study investigates the effects of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) on agitation in hospice care-eligible patients with dementia. Over a 12-week period, approximately 150 participants aged 40 and older will be randomly assigned to receive either the active drug or a placebo. The primary outcome will be measured using the Cohen Mansfield Agitation Inventory (CMAI) to assess changes in agitation levels. An optional 12-week open-label extension will be available for participants who complete the initial phase.

Who should consider this trial

Good fit: Ideal candidates are hospice care-eligible individuals aged 40 and older who exhibit clinically significant agitation and meet the criteria for Major Neurocognitive Disorder.

Not a fit: Patients who are not hospice care-eligible or do not exhibit significant agitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce agitation in patients with dementia, improving their quality of life.

How similar studies have performed: While studies on cannabinoids for agitation in dementia are limited, preliminary research suggests potential benefits, making this approach promising yet relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chula Vista, California and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AgitationDementiaagitationhospice care-eligibledementiaagitation and dementiaalzheimer's diseasealzheimer's disease dementia
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.