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AgitationPhase 2LiBBYNCT05644262

Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

A Phase 2 study testing T2:C100 in people with Agitation and Dementia, run by University of Southern California at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Agitation, Dementia
What is being tested?
T2:C100
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
10 sitesUnited States
Study dates
5 Jan 2024to 28 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • 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.

Who cannot join

  • Use of cannabinoids or other forms of marijuana in the 3 weeks prior to Baseline, as based on self-report.
  • 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).
  • 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.
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Case Western Reserve University

    Beachwood, Ohio, 44122

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • University of Kentucky

    Lexington, Kentucky, 40504

  • Melgar-Caro Medcenter and Community Research (MCMCR)

    Miami, Florida, 33145

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee, 37212

  • University of South Florida

    Tampa, Florida, 33612

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Howard University

    Washington D.C., District of Columbia, 20059

Other trials in United States

About this study

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

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
Being tested
T2:C100, Placebo
Keywords
agitation, hospice care-eligible, dementia, agitation and dementia (HAD), alzheimer's disease, alzheimer's disease dementia, alzheimer's disease and related dementias
Medical subject headings
Psychomotor Agitation, Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T2:C100Drug

    Also called TRC/CBD oral combination

    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)).

  • PlaceboDrug

    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)).

Study groups in NCT05644262
Study groupRoleWhat they receive
T2:C100ExperimentalNot described
Receives: Drug: T2:C100
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks

    The Cohen-Mansfield Agitation Inventory (CMAI) assesses the average frequency of manifestations of agitated behaviors in elderly persons over a 1-week period. The CMAI is a questionnaire consisting of 29 agitated behaviors, each rated on a 7-point frequency scale. In addition to the frequency of each behavior, informants/caregivers will be asked to use a 5-point scale to rate the disruptiveness of each behavior. For this study, the CMAI will target behaviors observed by knowledgeable informants/informed caregivers. Expanded descriptions of the behaviors will be provided to the informant/caregiver to be used as a reference during the interview.

    Measured: Baseline, Day 7 and Day 14

Secondary outcomes (2)

  1. Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 12 weeks

    The Cohen-Mansfield Agitation Inventory (CMAI) assesses the average frequency of manifestations of agitated behaviors in elderly persons over a 1-week period. The CMAI is a questionnaire consisting of 29 agitated behaviors, each rated on a 7-point frequency scale. In addition to the frequency of each behavior, informants/caregivers will be asked to use a 5-point scale to rate the disruptiveness of each behavior. For this study, the CMAI will target behaviors observed by knowledgeable informants/informed caregivers. Expanded descriptions of the behaviors will be provided to the informant/caregiver to be used as a reference during the interview.

    Measured: Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12

  2. Clinical Global Impression of Change in Behavior (CGIC-B)

    The Clinical Global Impression of Change in Behavior (CGIC-B) is similar to the mADCS-CGIC in that both versions provide a systematic method for assessing clinically significant change in clinical trials as evaluated by an experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination and/or observation of the participant as well as interviews with a knowledgeable informant/informed caregiver. The participant interviews that are a part of the mADCS-GGIC are not feasible in this study population and have been eliminated in the CGIC-B in favor of standard administration across all participants. Anchors present in the mADCS-CGIC that are not relevant in this study population have been removed and agitation-related anchors have been added to the CGIC-B. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).

    Measured: Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start5 Jan 2024
  3. Primary completion25 Nov 2025
  4. Study completion28 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05644262
Sponsor's protocol ID
ATRI-007
Other IDs
R01AG068324, R01AG095004
Acronym
LiBBY
Status last verified
Aug 2026
First submitted
16 Nov 2022
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Cummings JL, Zhong K, Ballard C, Sano M, Mintzer J. Clinical trials for neuropsychiatric syndromes in major and mild neurocognitive disorders: A CONSORT-based approach. Int Psychogeriatr. 2025 Dec;37(6):100107. doi: 10.1016/j.inpsyc.2025.100107. Epub 2025 Jun 24.

    PubMed 40562636

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing T2:C100 in people with Agitation and Dementia, run by University of Southern California at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05644262, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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