SciSparc Ltd.SPRC, a leading clinical drug company that develops treatments for disorders of the central nervous system, has announced positive results from its investigator-initiated phase IIa trial at the Sophie Abraham Stuchynski Israeli Alzheimer's Medical Center IMCA, which suggest that the company's proprietary SCI-110 is safe and tolerable while significantly improving agitation symptoms over time in elderly populations with Alzheimer disease and agitation.
This phase IIa clinical trial was an open label study of 18 patients diagnosed with ADD and agitation to evaluate safety, tolerability, and efficacy trends of twice daily oral administration of SCI - 110. The study met its primary endpoints of poor tolerability and the number of adverse events related to trial treatment SCI-110, with no SCI-110 related safety issues observed and no dropouts from the trial due to trial medication.
SCI - 110 did not result in delirium, oversedation, hypotension or falls. In addition, analysis of the trial results revealed that the trial also met its secondary end point of change from baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory CMAI where out of the fifteen patients treated with SCI - 110 at least two consecutive times during the trial, thirteen of them at doses ranging from 7.5 mg - 12.5 mg day showed improvement in agitation with no need to use rescue medication to control agitation. CMAI is a common measure for measuring agitation in people with dementia. The trial showed that these subjects had improvement in agitation. The average reduction across the entire sample was 23%, compared to an average reduction of 23%.
In the exploratory end points, a decrease in eating and feeding difficulties was shown in 11 patients out of 15 patients treated at least two consecutive times during the trial, measured by the Edinburgh Feeding Evaluation in Dementia Scale, although the increase was not significant. No significant effect of the treatment was observed on cognitive measures and sleep quality, measured by the Mini Mental State Exam and the Sleep Disorder Inventory, respectively.
The trial medication was well tolerated with no negative response to the treatment observed throughout the trial duration.