NCT05644262: LiBBY

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

Active, enrolled Phase 2 Last updated 28 April 2026

What this trial tests

Phase 2 trial testing T2:C100 in Agitation in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 December 2023

Primary endpoint
30 April 2026

1 August 2026

Quick facts

Lead sponsor	University of Southern California
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	18 December 2023
Primary completion	30 April 2026
Estimated completion	1 August 2026
Sites	10 locations across United States

Drugs / interventions tested

• T2:C100 — full drug profile →
• Placebo

Conditions studied

• Agitation — all drugs for Agitation →
• Dementia — all drugs for Dementia →

Sponsor

University of Southern California

Who can join

40 and older, any sex, with Agitation or Dementia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  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

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trials for neuropsychiatric syndromes in major and mild neurocognitive disorders: A CONSORT-based approach.
   Cummings JL, Zhong K, Ballard C, Sano M, et al · · 2025 · cited 1× · PMID 40562636 · DOI 10.1016/j.inpsyc.2025.100107
2. Refractory Psychosis as a Red Flag for End of Life in Individuals With Dementia With Lewy Bodies: A Case Series and Re-analysis of Prior Qualitative Data.
   Armstrong MJ, Galvin JE, Manning C, Boeve BF, et al · · 2025 · cited 1× · PMID 39878295 · DOI 10.1097/wad.0000000000000660
3. Estimating Socio-Economic Status for Alzheimer's Disease Trials.
   Rentz DM, Grill JD, Molina-Henry DP, Jicha GA, et al · · 2024 · cited 1× · PMID 39350389 · DOI 10.14283/jpad.2024.88
4. Neurotransmitter Systems in Alzheimer's Disease.
   Ramírez-Expósito MJ, Cueto-Ureña C, Martínez-Martos JM. · · 2026 · PMID 41899485 · DOI 10.3390/cimb48030334