A THC:CBD oil shows promising results in reducing agitation in people with dementia

A Phase II clinical trial presented at the Alzheimer's Association International Conference in London suggests that a purified oral formulation combining THC and CBD could significantly reduce agitation in people with dementia at an advanced stage.

The results of the’LiBBY test, presented by researchers from the Medical University of South Carolina and Georgetown University, indicate that the treatment led to rapid and lasting improvements while exhibiting a safety profile comparable to that of a placebo.

These findings are generating a great deal of interest, as agitation remains one of the most difficult symptoms to manage in patients with dementia in the terminal stage, and current treatment options are often associated with limited efficacy and significant side effects.

Rapid and lasting reduction in agitation

TheLiBBY test (Life’s End: The Benefits of Cannabidiol and Tetrahydrocannabinol) recruited 120 participants eligible for palliative care, among whom Alzheimer's disease or other forms of dementia had been diagnosed at 10 medical centers in the United States. To reduce stress for the participants, all study visits were conducted at their homes or places of residence.

The researchers evaluated a pharmaceutical-grade oral oil containing 2 mg of THC per 100 mg of CBD, to be administered twice daily, comparing it to a placebo in a randomized, double-blind, placebo-controlled study. Neither the patients, nor the caregivers, nor the clinicians knew who was receiving the active treatment.

From the start of the study through week 1, participants received a half dose (2 mg of THC and 100 mg of CBD, twice daily) or a placebo. During weeks 2 through 12, participants received the full dose of the treatment (4 mg of THC and 200 mg of CBD, twice daily) or a placebo.

The primary outcome measure was assessed after two weeks using the’Cohen-Mansfield Agitation Inventory (CMAI), a standardized scale measuring 29 behaviors related to agitation. Patients receiving the active treatment showed a reduction in agitation scores that was 6.27 points greater than that observed in the placebo group. This improvement remained significant after 12 weeks.

A secondary analysis using the’Overall Clinical Impression of Behavioral Change also showed promising results. According to the researchers, 83.9% of the patients receiving the treatment showed behavioral improvement after two weeks, compared with 30.5% in the placebo group. At week 12, the response rate reached 87.2% in the treatment group, compared with 23.6% in the placebo group.

A potential alternative to existing treatments

Agitation associated with advanced-stage dementia often manifests as aggression, restlessness, and emotional distress, which place a heavy burden on both patients and caregivers. Current medications, including sedatives and antipsychotics such as Valium or the’Haldol, may provide limited relief while increasing the risk of adverse side effects.

«These clinical trial results are extremely impressive and have demonstrated a level of response never before seen in clinical trials related to dementia. It is rare to see nearly 90% of patients in a trial respond positively to a new drug,» said the co-principal investigator Jacobo Mintzer.

Her colleague, the investigator Brigid Reynolds, explained the unmet medical need : «Agitation affects many people with advanced dementia, causing symptoms such as restlessness, aggression, and emotional distress that can have a profound impact on patients and their caregivers. Current treatment options are limited and often come with significant side effects, underscoring the need for safer and more effective treatments.»

The study also reported similar rates of adverse events between the active-treatment group and the placebo group, with infections and gastrointestinal disorders occurring at levels expected for this frail patient population.

Researchers caution against comparing the treatment with commercial products

Despite these encouraging results, the research team noted that the formulation used in the’LiBBY test should not be confused with products made from THC or CBD commercially available.

«We shouldn’t assume that products available at dispensaries or online are equivalent to what was studied in this trial,» said Ms. Reynolds. «The medication used in this research was carefully formulated, manufactured, and administered under close medical supervision. Over-the-counter or commercially available THC- and CBD-based products can vary widely in terms of composition, quality, and dosage, making them potentially ineffective or even harmful.»

A caregiver who participated in the study described noticeable emotional improvements, even though she never knew whether her mother had received the active treatment or a placebo. «She seemed happier,» Laura said. «We felt joy. There were still moments of closeness.»

These results, published by MedicalXpress remain preliminary until they are published in a peer-reviewed journal. Nevertheless, this trial represents one of the most compelling clinical indications to date of the potential of purified formulations of THC and CBD as a treatment option for agitation associated with dementia progress, while emphasizing the importance of distinguishing between pharmaceutical preparations and cannabis-derived products sold at retail.