Clinical-stage neuroscience company Cognition Therapeutics has released positive topline results from its Phase 2 SEQUEL study of CT1812, a drug aimed at treating mild-to-moderate Alzheimer’s disease. The study met its primary goals of safety and tolerability and showed that CT1812 had a positive effect on global and regional brain activity.
The study focused on brain wave changes over a four-week treatment period and found that participants treated with CT1812 experienced a numerical reduction in relative theta power, indicating an improvement in underlying brain function. The study also revealed statistically significant decreases in relative theta power in the central region, as well as positive changes in AECc and alpha power.
Furthermore, CT1812 treatment was associated with increased connectivity between brain regions, as observed through an AECc analysis of quantitative electroencephalogram (qEEG) results. Effective communication and information exchange between brain regions are crucial for cognition.
“My colleagues and I are excited to see this favorable result, which suggests that treatment with CT1812 may be directly impacting overall brain health, as illustrated in a change in relative theta power globally and across brain regions,” said Dr Everard Vijverberg, a neurologist at the Amsterdam University Medical Centers, and principal investigator in the trial. “We look forward to continuing our work with Cognition as a clinical trial collaborator in the SHINE study, which is studying CT1812 over a six-month treatment period in 144 adults with mild-to-moderate Alzheimer’s disease.”
The study was supported by a grant from the National Institute on Aging and aimed to assess differences in synaptic function between CT1812-treated and placebo-treated participants using qEEG. The researchers employed sophisticated algorithms to quantify small changes in brain activity, providing insights into activity levels within and between brain regions. qEEG may serve as a non-invasive biomarker for Alzheimer’s disease progression and treatment effects.
“Though an exploratory endpoint, there is substantial evidence to believe that qEEG can detect changes in both whole-brain and regional electrical patterns that are impaired in Alzheimer’s disease,” said Dr Anthony Caggiano, chief medical officer and head of R&D at Cognition, which is focused on discovering and developing small molecule therapeutics for age-related degenerative disorders of the central nervous system and retina.
“These results show CT1812’s impact on neurophysiological endpoints, which add to the growing body of evidence that we have compiled in our preclinical and clinical programs: CT1812’s target engagement observed in the SNAP study, its impact on anatomical endpoints observed in the SPARC study, and preliminary cognitive impact seen in the first cohort of patients in the SHINE study.”
Full analyses of the SEQUEL study results, including analyses of Alzheimer’s canonical biomarkers and proteomics, will be presented at an upcoming medical meeting.