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SciSparc Announced Positive Interim Results Meeting Primary Endpoints at Phase IIa Study in Alzheimer’s Disease Patients with Agitation
Meets primary endpoints- SCI-110 administration was found to be safe at all tested dosesSCI-110 treatment was also found to reduce agitation - 75% of patients
About this update from Scisparc Ltd.
[{"type":"text","content":"Meets primary endpoints- SCI-110 administration was found to be safe at all tested dosesSCI-110 treatment was also found to reduce agitation - 75% of patients did not need to use additional medication to control agitation and 75% of patients experienced increased appetiteSciSparc has previously shown positive results using SCI-110 in Tourette syndrome Tel-Aviv, Nov. 07, 2022 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), today announced positive interim results from its Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation. Agitation manifests in the course of AD progression in almost all affected patients, increasing patients’ suffering and burden of care. 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 q...