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SciSparc Completed Treatment of Last Patient Enrolled for its Phase IIa Clinical Trial for Alzheimer's Disease and Agitation
The Company previously announced positive interim results from the trial meeting its primary endpoints TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) --
About this update from Scisparc Ltd.
[{"type":"text","content":"The Company previously announced positive interim results from the trial meeting its primary endpoints TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that the last patient enrolled in the Company's Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation, completed its treatment. The Company is expecting to receive the final trial results in the upcoming weeks. On November 7, 2022, the Company announced positive interim results from the open label trial, 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 trial as per protocol. At the interim analysis, the trial met its primary endpoints of safety, including non-treatment related adverse events and drop out patients from the trial; 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 trial 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). In general, the trial medication was well tolerated with no negative response to the treatment observed during the duration of the trial (32 days of treatments and seven days for follow-up afte...