Over a 39-day period, treatment with SCI-110 resulted an average reduction of 23% in agitation among patients with Alzheimer disease.
Newly announce data from an investigator-initiated phase 2 trial showed that treatment with SCI-110 (SciSparc), a cannabinoid-centric agent, met its primary end point of tolerability, with significant amelioration in agitation among patients with Alzheimer disease (AD) and agitation.
The single-arm, open-label trial comprised of 18 individuals with AD and agitation who received twice-daily treatment of SCI-110 for a 32-day treatment period, followed by a 7-day post-treatment completion. SCI-110 is a unique and proprietary combination of Dronabinol, an FDA-approved, synthetic version of delta-9-tetrahydrocannabinol, and CannAmide, SciSparc’s proprietary formulation of palmitoylethanolamide.
At the conclusion of the 39-day period, results showed that the trial met its primary end points of the number of drop-outs because of poor tolerability and the number of treatment-related adverse events. The agent was well tolerated, with no related dropouts, and no instances of delirium, oversedation, hypotension, or falls.
The trial also met its secondary end point of change in Cohen Mansfield Agitation Inventory (CMAI) total score, a measure of agitation in individuals with dementia. All told, 13 of the 15 individuals who were treated with SCI-110 for at least 2 consecutive times during the trial at doses ranging between 7.5 mg-12.5 mg/day demonstrated amelioration of agitation, with no need to use rescue medication to control their condition.
"We are extremely pleased with the results announced today, the tolerability and improvement the patients presented in the symptoms of the disease are remarkable. Alzheimer disease' patients experience many different symptoms that deteriorate their condition including lack of appetite, sleep quality and agitation," Adi Zuloff-Shani, PhD, chief technology officer, SciSparc, said in a statement.1 "The possibility of improving quality of life for patients and even reducing the need to use rescue medications is an enormous accomplishment for SciSparc. These results further support our efforts to develop proprietary innovative treatments with the ability to change millions of lives worldwide."
At the conclusion of the study period, treatment with SCI-110 resulted in a 10.6 (±14.88; P = .015) point mean change in CMAI total score across the entire sample. This amelioration equated to an average reduction of 23%. Additionally, the therapy had positive, nonsignificant effects on eating and feeding difficulties, as 11 of the 15 patients treated at least 2 consecutive times showed increases on the Edinburgh Feeding Evaluation in Dementia Scale. Notably, no impact was observed on cognitive measurements and sleep quality, as measured by the Mini Mental State Exam and the Sleep Disorder Inventory, respectively.
In addition to AD agitation, SCI-110 is currently being investigated for other conditions such as Tourette syndrome and obstructive sleep apnea. Recently, in March, the Israeli Ministry of Health approved SciSparc’s phase 2b trial (NCT05126888) of SCI-110 in patients with Tourette syndrome, which remains currently enrolling. The multinational, double-blind, placebo-controlled crossover study will randomly assign patients 1:1 to either study drug or placebo, with changes in tic severity of a 26-week period as the primary outcomes.