After Disappointing Parkinson's Data, Sage Therapeutics' Dalzanemdor Flunks Mid-Stage Alzheimer's Study
After Disappointing Parkinson's Data, Sage Therapeutics' Dalzanemdor Flunks Mid-Stage Alzheimer's Study
Based on these data, the company does not plan further clinical development of dalzanemdor in Alzheimer's. The company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington's Disease later this year.Tuesday, Sage Therapeutics, Inc. (NASDAQ:SAGE) released topline results from the Phase 2 LIGHTWAVE study to evaluate the effects of dalzanemdor (SAGE-718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD).
全球貨幣週二公佈了從第2期LIGHTWAVE研究中獲取的頂線結果，評估了dalzanemdor（SAGE-718）對輕度認知障礙（MCI）或輕度癡呆症（AD）患者的影響。
The LIGHTWAVE Study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at Day 84, the study's primary outcome measure.
在LIGHTWAVE研究中，與安慰劑治療的參與者相比，dalzanemdor治療的參與者在第84天的WAIS-IV編碼測試得分未顯示與基線有統計學顯著差異，這是研究的主要結果指標。
The WAIS-IV test assesses the intellectual abilities of people aged between 16 and 90. A total of 174 participants were randomized.
WAIS-IV測試評估了年齡在16至90歲之間的人的智力能力。總共有174名參與者被隨機分配。
Based on these data, the company does not plan further clinical development of dalzanemdor in Alzheimer's. The company expects to report topline data from the Phase 2 DIMENSION Study of dalzanemdor in people with cognitive impairment associated with Huntington's Disease later this year.
根據這些數據，公司不打算在阿爾茨海默病中進一步開展dalzanemdor的臨床開發。該公司預計將於今年晚些時候報告dalzanemdor在與亨廷頓病相關的認知障礙患者中進行第2期DIMENSION研究的頂線數據。
Dalzanemdor was generally well-tolerated, and no new safety signals were observed. The majority of treatment-emergent adverse events were mild to moderate in severity.
Dalzanemdor通常耐受良好，並且沒有觀察到新的安全信號。大多數治療相關的不良事件的嚴重程度爲輕度至中度。
Analyses did not demonstrate any meaningful differences in the dalzanemdor-treated group versus placebo in exploratory endpoints such as Repeatable Battery for Assessment of Neuropsychological Status (RBANS) and the Montreal Cognitive Assessment (MoCA), both cognitive tests.
分析未顯示dalzanemdor治療組與安慰劑在RBANS和MoCA等探索性終點指標方面存在任何有意義的差異，這兩種均爲認知測試。
Earlier this year, PRECEDENT Phase 2 study of dalzanemdor in people with mild cognitive impairment in Parkinson's Disease also failed to meet its primary endpoint.
今年早些時候，dalzanemdor在帕金森病輕度認知障礙患者中的PRECEDENt第2期研究也未能達到其主要終點。
In September, Sage Therapeutics announced that Biogen Inc (NASDAQ:BIIB) terminated its rights under the collaboration and license agreement with Sage, which was specific to the SAGE-324 program.
9月，sage therapeutics宣佈Biogen Inc（納斯達克：BIIB）終止了與sage的合作及許可協議下的SAGE-324項目的權利。
The companies recently announced negative results from the Phase 2 KINETIC 2 Study of investigational SAGE-324 for the chronic treatment of essential tremor (ET) and discontinued further clinical development of SAGE-324 in ET.
這些公司最近宣佈了在調查sage therapeutics的SAGE-324用於慢性治療原發性震顫（ET）的第2期KINETIC 2研究中獲得的負面結果，並終止了對SAGE-324進一步臨床開發的計劃。
Price Action: At last check on Tuesday, SAGE stock was down 11.30% at $5.96 during the premarket session.
價格走勢：截至上週二最後檢查時，sage therapeutics的股價在盤前交易中下跌了11.30%，至5.96美元。
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