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Expert Interview

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Discussing Sage’s SAGE-718 in Alzheimer’s Disease Dementia

Ticker(s): SAGE

Who's the expert?

A neurologist with experience in treating Patients with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease.

Interview Questions
Q1.

Please describe your clinical practice. How many patients with Alzheimer’s do you see on a yearly basis? What percent suffer from Mild Cognitive Impairment/ Mild Dementia, and what is the standard of care for them?

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Q2.

Could you please discuss with us about the recent results of the executive performance tests and the improvement on key tests of learning and memory in the LUMINARY Study? How does it compare to standard of care?

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Q3.

What’s your impression on the results for the Montreal Cognitive Assessment (MoCA) (+2.3 points vs baseline) observed at Day 28. And also on the fact that no effect was observed on measures of simple attention/psychomotor speed, how disappointing is that?

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Q4.

How relevant are the tests the company performed, namely the 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). Are there any other results you’d expect to see in an Alzheimer’s Dementia trial?

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Q5.

In more detail, the study enrolled 11 patients, mean (SD) age was 69.1 (6.9) years, mean (SD) MoCA baseline score was 23.8 (2.3), 100% white, 91% Hoehn and Yahr stage 2, and 82% male. Multiple domains of cognitive performance were assessed. SAGE-718 was associated with improved performance at Day 14, compared with baseline on tests of executive functioning (Multitasking, Stockings of Cambridge, Spatial Working Memory, Digital Symbol Substitution, and Two-back Test). An emerging signal suggested improved performance on tests of learning and memory (Paired Associates, Pattern Recognition, and Verbal Memory). No appreciable effect was observed on measures of simple attention/psychomotor speed. The most common adverse events (AEs) were headache, somnolence, and dizziness. No severe/serious AEs or deaths were reported, and no treatment-emergent AEs resulted in study drug discontinuation or study withdrawal. Plasma concentration data suggest a pharmacokinetic profile consistent with previous studies.

  • The company touts promising signals on learning and memory. How convinced are you by those results?
  • What are the still unmet needs in this area that you’d like to be addressed?
  • How likely are you to consider SAGE-718 for your patients, in the future, based on the data available?

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