Clinical-stage pharmaceutical company SciSparc Ltd. announced that The Israeli Medical Center for Alzheimer’s has recruited the first patient for a clinical trial using the company’s proprietary cannabinoid-based technology.
The subject will participate in the company’s Phase IIa clinical trial that will evaluate the safety, tolerability and efficacy of SciSparc’s SCI-110 in patients with Alzheimer’s disease and agitation. SciSparc focuses on the development of therapies to treat disorders of the central nervous system.
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 behavioral 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, SciSparc said in a statement. 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 Brings Increased Risks
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.
SciSparc said that 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, according to the company. Moreover, the U.S. Food and Drug Administration has placed a “black box” warning on some of these drugs describing the risks.
“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,” said SciSparc Chief Technology Officer Dr. Adi Zuloff-Shani, Ph.D. “Unfortunately, patients have very limited efficient treatments available today and those available can cause side effects, like drowsiness, rigidity and unusual movements.”
Zuloff further explained that studies have linked some of those medications 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,” he added.
SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists whose focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals.
The company is currently engaged in drug development programs based on THC and/or non-psychoactive cannabidiol (CBD), such as SCI-110 for the treatment of Tourette syndrome, for the treatment of obstructive sleep apnea and Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and epilepsy.
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. The center facilitates numerous studies in collaboration with researchers at universities.
