On November 7, SciSparc announced positive interim results from its Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (AD) and agitation.
This Phase IIa clinical trial is an open label study, which includes 20 patients diagnosed with AD and agitation, to evaluate the safety, tolerability and efficacy trends of twice daily oral administration of SCI-110. The interim results summarize the data from the first eight patients who completed the study as per protocol.
At the interim analysis, the study met its primary endpoints of safety, including non-treatment related adverse events and drop out patients from the study; specifically, SCI-110 did not cause delirium, oversedation, hypotension or falls even in the highest dose tested (12.5MG Dronabinol+400mg PEA).
In addition, the interim analysis showed that the study also met its secondary endpoint of Change from Baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (“CMAI”); out of the eight patients, six showed amelioration in agitation with no need to use rescue medication to control agitation. CMAI is a standard measure for measuring agitation in people with dementia.
Additionally, the interim analysis showed in the exploratory endpoints that appetite was increased in six out of the eight patients, as measured by the Edinburgh Feeding Evaluation in Dementia Scale. No effect was observed on cognitive measurements and sleep quality, as measured by the Mini Mental State Exam, and by the Alzheimer's Disease Assessment Scale-cognitive subscale (for cognitive impairment assessments) and the Pittsburgh Sleep Quality Index (for quality of sleep assessment).
About SCI-110
SCI-110 is a unique and proprietary combination of Dronabinol, an FDA-Approved, synthetic version of delta-9-tetrahydrocannabinol, and CannAmide, the Company’s proprietary formulation of Palmitoylethanolamide.
SCI-110 is one of the innovative combinations of SciSparc’s cannabinoid-centric platform. Using its proprietary technology, SciSparc creates these combinations to augment the inherent properties of different cannabinoids, in this case, Dronabinol, enhancing their ability to bind with receptors in the endocannabinoid system. The potential result, as demonstrated in pre-clinical studies, is improved efficacy and, in turn, lower dosage requirements and reduced side effects as compared to the cannabinoid when administered alone.
About Alzheimer’s Disease
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Alzheimer’s Disease(AD) is an irreversible neurodegenerative disease that causes progressive and disabling impairment of cognitive functions including memory, comprehension, language, attention, reasoning, and judgment. Neuropsychiatric symptoms such as apathy, social withdrawal, disinhibition, agitation, psychosis, insomnia, poor appetite, and wandering are also common in the mid to late stages.
