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April 4, 2022

Sage reports positive Phase II Alzheimer’s disease drug trial data

In the trial, SAGE-718 was found to be well-tolerated in AD patients with no serious adverse events or deaths reported.

Sage Therapeutics has reported promising data from the Phase II LUMINARY clinical trial of neuropsychiatric drug candidate, SAGE-718, in individuals with mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD).

SAGE-718 is an oral positive allosteric modulator of the N-methyl-D-aspartate (NMDA) receptor.

The open-label trial analysed 3mg once-a-day dose of SAGE-718 for 14 days in subjects aged 50 to 80 years with AD-associated MCI and mild dementia.

It assessed the occurrence of the treatment-emergent adverse event through day 28 as the primary endpoint. 

Various other safety outcomes were included as secondary endpoints while cognitive and functional evaluations were being carried out as part of the trial.

According to the findings, the oral therapy was found to be well-tolerated in trial subjects.

Progress from baseline was reported at day 14 on various tests of executive functioning, namely Digit Symbol Substitution, Multitasking, One Touch Stockings, Spatial Working Memory and 2-Back tests.

Furthermore, improvements were seen in tests of learning and memory namely Pattern Recognition Memory and Verbal Recognition Memory tests in 26 trial subjects.

The company also reported a statistically significant increase of 2.3 points in the Montreal Cognitive Assessment (MoCA) from baseline at day 28 following treatment. 

Furthermore, no serious adverse events or deaths were observed in the trial.

Sage Therapeutics chief development officer Jim Doherty said: “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 programme, including in people with Parkinson’s and Huntington’s disease. 

“We look forward to learning more about the potential of SAGE-718 as we continue to advance our programme with multiple ongoing or planned Phase II studies.”

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