Patient recruitment underway in phase 2a trial for cannabis oil dementia treatment

MediCane Health Inc. announced recruitment of the first patient for its phase 2a study designed to assess the effects of cannabis oil in adults with probable Alzheimer’s disease who have limited or no response to antipsychotic medication.

According to a company release, the trial is being conducted in two leading academic hospitals in Israel — Sheba Medical Center and Sourasky Medical Center. The trial will include 55 participants, who will receive MediCane’s balanced THC:CBD orally administered cannabis oil extracted from MediCane’s proprietary strain and formulated for blinding purposes, in addition to standard care.

The first part of the study is an open-label phase that will enroll 15 participants for safety and dose-range finding, followed by a randomized, double-blind, placebo-controlled second phase that will include 40 participants to evaluate safety and efficacy, the company stated.

According to the release, agitation and disruptive behaviors, expressed as excessive fidgeting, restlessness, pacing, shouting, screaming, uninhibited behaviors and aggression, are present in over half of patients with dementia at some point during the illness.

“MediCane is proud to collaborate with two of the leading medical centers in Israel in our journey to find a safe and effective cannabis-based medicine for [behavioral and psychological symptoms of dementia] symptom relief,” Nurit Tweezer-Zaks, MD, MBA, CEO of MediCane research and development, said in the release. “Through this joint effort we hope to be able to successfully complete the study during 2024 and launch the product in Israel, Germany and additional EU markets.”