Cognition Therapeutics, Inc. announced topline results from its Phase 2 double-blind, single-crossover SEQUEL study (NCT04735536 of CT1812 in 16 adults with mild-to-moderate Alzheimer’s disease. The study, which was conducted in the Netherlands, met its primary endpoints for safety and tolerability and showed positive effects for CT1812-treated participants as measured via quantitative electroencephalogram (qEEG). Research suggests that overall slowing of brain activity in Alzheimer's disease can be measured by an increase in relative theta power using qEEG and other measures of brain connectivity.

The SEQUEL study examined brain wave changes over 4 weeks of treatment and showed that participants treated with CT1812 experienced a numerical reduction in relative theta power compared to the period when they were on placebo. While not statistically significant, these data indicate a positive impact on underlying brain function and are supported by nominally significant and directionally positive changes in AECc and alpha power. In addition to global measures of brain activity, this study assessed brainwave changes in frontal, central, temporal and posterior (occipital and parietal) regions.

Treatment with CT1812 was associated with decreases in relative theta in each of these regions, with statistical significance in the change in relative theta in the central region. In addition to changes in theta wave patterns, an AECc analysis of the qEEG results showed that CT1812 treatment was associated with nominally statistically significantly greater connectivity between brain regions. The brain’s ability to communicate and exchange information between regions is critical to cognition.

The SEQUEL study, which was supported by a grant from the National Institute on Aging (R01AG058710), was designed to assess differences in synaptic function in CT1812-treated versus placebo-treated participants using qEEG to measure changes in brain wave patterns. The sophisticated algorithms used by qEEG allow small changes in brain activity to be quantified. The changes in amplitude and frequency of wavebands over time can provide insight into the levels of activity in and between brain regions.

As a fast and cost-effective method of measuring the electrical activity of the brain, qEEG may represent a non-invasive biomarker of Alzheimer's disease progression and treatment effect.