SciSparc Ltd., a clinical-stage pharmaceutical company, announced that The Israeli Medical Center for Alzheimer's has recruited the first patient to participate in the company's phase IIa clinical trial that will evaluate the safety, tolerability and efficacy of SCI-110 in patients with Alzheimer's disease and agitation using the company's proprietary cannabinoid-based technology.

The trial's primary objective is evaluating the safety of SCI-110 and the secondary objective is evaluating the ability of the compound to ameliorate agitation and other behavioural disturbances in patients with Alzheimer's disease.

The trial, titled "Clinical Study Protocol Phase II-a open label trial to evaluate the safety, tolerability and efficacy trend of SCI-110 in patients with Alzheimer Disease and agitation," will be conducted at the Sophie & Abraham Stuchynski Israeli Alzheimer's Medical Center, Ramat-Gan, Israel.

The drug product SCI-110 is a unique proprietary combination of Dronabinol (synthetic delta-9-tetrahydrocannabinol (??-THC), and Palmitoylethanolamide (PEA).

Alzheimer's disease is the most common type of dementia, accounting for over two-thirds of cases of dementia. Alzheimer's disease is a neurodegenerative disease that causes progressive and disabling impairment of cognitive functions, including memory, comprehension, language, attention, reasoning and judgment. Symptoms of Alzheimer's disease depend on the stage of the disease. Neuropsychiatric symptoms like apathy, social withdrawal, disinhibition, agitation, psychosis, insomnia, poor appetite and wandering are also common in the mid to late stages. Agitation is common in nearly 60% of patients with dementia, increases caretaker burden, creates safety risk for individuals with dementia and others and increases risk for hospitalization and nursing home placement. The current pharmacological treatment of agitation in Alzheimer's disease has an unsatisfactory benefit/risk ratio and often involves using off-label drugs. Antipsychotic drugs, which are the most frequently used drugs for this purpose, are only marginally better than placebo. Moreover, the US Food and Drug Administration has placed a "black box" warning on some of these drugs describing the risks.

"We are excited to achieve this important milestone of recruiting the first patient for our Phase IIa clinical trial. As the population of the world continues to age, Alzheimer's disease is one of the most common diseases affecting the elderly, and subsequently the number of patients suffering from agitation also dramatically increases. Unfortunately, patients have very limited efficient treatments available today and those available can cause side effects, like drowsiness, rigidity and unusual movements. Studies have linked some of these to a higher risk of death for people with dementia. We are hoping our innovative treatment will provide patients and their families, with an efficient treatment option," said Dr. Adi Zuloff-Shani, PhD, chief technology officer of the company.

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists.

The Israeli Medical Center for Alzheimer's (IMCA) is the only medical center in Israel exclusively devoted to the treatment of Alzheimer's disease patients. IMCA was founded in 1994 as a public, not for profit foundation, and in July 2001 it opened as an active medical center.