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LiBBY

Active not recruitingPhase 2

Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

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

Asset

T2:C100

Listed sites

10

Recruiting sites

-

Enrollment

120

estimated

Study population

Mixed / unspecified dementia

Key I/E criterion

Study partner/caregiver required

Primary endpoint

Agitation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDATRI-007
NCT IDNCT05644262
NihR01AG068324
NihR01AG095004

Timeline

Milestones

Study first posted2022-12-09actual
Study start2023-12-18actual
Primary completion2026-04-30estimated
Last update posted2026-05-04actual
Study completion2026-08-01estimated

Assets

Drug assets

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersNot 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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Day 7, Day 14, Week 4, Week 8 and Week 12

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.