Results Show Positive Treatment Effect of CT1812 on Global and Regional Brain Activity
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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.
“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 Everard (Jort) Vijverberg, M.D., Ph.D., a neurologist and senior researcher at the Amsterdam University Medical Centers, and principal investigator in SEQUEL. “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.”
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.
“While the study of brain connectivity is evolving, many consider this to be a highly relevant measure, as it demonstrates how well a brain network is functioning,” added explained
As observed in previous studies, CT1812 was well-tolerated in the SEQUEL study with most adverse events being mild-to-moderate in severity. There were no treatment-related SAEs reported.
The SEQUEL study, which was supported by a grant from the
“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
Full analyses of the results from SEQUEL will be presented at an upcoming medical meeting, as will analyses of Alzheimer's canonical biomarkers and proteomics from fluid samples collected from SEQUEL participants.
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About CT1812
CT1812 is an experimental orally delivered small molecule designed to penetrate the blood-brain barrier and bind selectively to the sigma-2 (σ-2) receptor complex. The σ-2 receptor complex is involved in the regulation of key cellular processes such as membrane trafficking and autophagy that are damaged by toxic interaction with soluble beta amyloid (Aβ) oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function, which manifests as cognitive impairment and Alzheimer’s disease progression. CT1812 is currently in development for mild-to-moderate Alzheimer’s disease in the SHINE study (NCT03507790) and dementia with Lewy bodies in the SHIMMER study (NCT05225415).
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