Sage expects to initiate additional Phase 2 studies evaluating SAGE-718 in Huntington’s, Parkinson’s and Alzheimer’s diseases in 2022. SAGE-718 is currently being studied in the ongoing Phase 2 DIMENSION Study, a double-blind placebo-controlled study in people with early to moderate cognitive impairment due to Huntington’s disease that is designed to evaluate the efficacy of once-daily dosed SAGE-718 over three months. Ongoing studies aim to evaluate whether SAGE-718 may have the potential to improve cognitive symptoms for these difficult-to-treat disorders. SAGE-718, Sage’s first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, potentially including Huntington’s disease, Parkinson’s disease and Alzheimer’s disease.
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Treatment-emergent adverse event incidence through Day 28 (primary endpoint), other safety outcomes (secondary endpoints) and cognitive and functional assessments were analyzed. Patients aged 50–80 years with MoCA scores of 15-24 were included. The LUMINARY Study was an open-label, Phase 2 study evaluating SAGE-718, 3mg once daily for 14 days in patients with mild cognitive impairment and mild dementia due to AD. No serious adverse events or deaths were reported. Eight mild/moderate treatment-emergent adverse events (TEAE) were reported in seven patients. SAGE-718 was generally well-tolerated in the LUMINARY Study. Functional assessments also captured notable improvement in some patients (Clinical Global Impressions Scales and Amsterdam Instrumental Activities of Daily Living Questionnaire), particularly on items measuring aspects of complex/higher order activities. As expected, no appreciable effect was observed on measures of simple attention/psychomotor speed, in keeping with the profile of SAGE-718 based on data to date. Statistically significant improvement in the Montreal Cognitive Assessment (MoCA) (+2.3 points vs baseline) was observed at Day 28. At Day 14, improvements from baseline were observed on multiple tests of executive functioning (Digit Symbol Substitution, Multitasking, One Touch Stockings, Spatial Working Memory, and 2-Back tests) and learning and memory (Pattern Recognition Memory and Verbal Recognition Memory tests). In the LUMINARY Study, a comprehensive battery of tests was used to assess multiple domains of cognitive performance in 26 patients receiving SAGE-718 3 mg once daily for 14 days. We look forward to learning more about the potential of SAGE-718 as we continue to advance our program with multiple ongoing or planned Phase 2 studies.” “We are encouraged by the positive results shared from the LUMINARY Study, which are consistent with signals suggesting improvement in cognitive performance seen across the SAGE-718 program, including in people with Parkinson’s and Huntington’s disease.
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“Alzheimer’s disease is one of the greatest areas of unmet patient need, with an estimated global prevalence of more than 134 million people and few, if any, treatment options to specifically address mild cognitive impairment and mild dementia,” said Jim Doherty, Ph.D., Chief Development Officer at Sage.
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The data will be presented during the Emerging Science Session on Tuesday, April 5, at the 74th Annual Meeting of the American Academy of Neurology (AAN) in Seattle.
Sage therapeutics trial#
The LUMINARY Study is part of CogNEXT, Sage’s early-stage trial platform designed to evaluate the therapeutic potential of SAGE-718 to treat cognitive deficits across a range of brain health disorders. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today the presentation of data from the Phase 2 LUMINARY Study that showed SAGE-718, a first-in-class, oral, positive allosteric modulator of the NMDA receptor, was generally well-tolerated and associated with improvement on multiple tests of executive performance and learning and memory in patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). SAGE-718 demonstrated improvement across multiple tests of executive performance as well as improvement on key tests of learning and memory in the LUMINARY StudyĬAMBRIDGE, Mass.-(BUSINESS WIRE)-Apr. The LUMINARY Study is a Phase 2, open-label study evaluating the safety, tolerability and efficacy of SAGE-718 once daily in individuals with mild cognitive impairment and mild dementia due to Alzheimer’s disease
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Data to be Presented During the Emerging Science Session at the American Academy of Neurology’s 74th Annual Meeting