Aaron Koenig, MD, Sage Therapeutics Inc., Cambridge, MA, gives insights into the upcoming LIGHTWAVE trial, a Phase IIb randomized, placebo-controlled study investigating the efficacy of SAGE-718 in patients with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). The trial acts as a follow-on to the Phase II LUMINARY safety and tolerability trial (NCT04602624), with its main aim being to find out whether the cognitive improvements observed over the two week LUMINARY dosing period will hold up for longer term. The LIGHTWAVE study will particularly focus on the efficacy of the drug using the Digit Symbol Substitution test: a short cognitive test that is very sensitive to changes in cognition and is thought to best represent everyday cognitive function in patients. Approximately 150 patients will be enrolled across the US and randomized to receive SAGE-718 or placebo for 12 weeks. This interview took place at the Clinical Trials on Alzheimer’s Disease Congress 2022 in San Francisco.
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•Aaron Koenig is an employee of Sage Therapeutics, Inc., and may hold stock and/or stock options. •The LUMINARY and LIGHTWAVE studies are sponsored by Sage Therapeutics, Inc. •SAGE‐718 is an investigational drug and is not approved by the US Food and Drug Administration or any other regulatory agency as safe and effective for any use.