Overview
- The phase II LiBBY trial enrolled 120 hospice‑eligible people with Alzheimer’s or other dementias and found a mean 6.27‑point improvement on the Cohen‑Mansfield Agitation Inventory at two weeks with sustained benefits through 12 weeks.
- Participants received an oral, clinic‑formulated dose of 4 mg THC and 200 mg CBD twice daily or placebo in a double‑blind, randomized design carried out across ten U.S. sites.
- Clinical global ratings showed about 84% of treated patients improved at two weeks versus 31% on placebo, rising to roughly 87% versus 24% by week 12.
- Adverse event rates were similar between groups (46.7% active vs 42.4% placebo) though there were more deaths in the active arm without an identifiable pattern in causes, and investigators reported no excess sedation, hallucinations, or anxiety in the treatment group.
- Researchers and the Alzheimer’s Association stressed that the study drug is a purified, medically administered formulation distinct from dispensary or over‑the‑counter cannabis products and that peer review, replication and regulatory review are required before clinical use.