Complete EEG results from SEQUEL study to be unveiled, demonstrating beneficial impact of CT1812 on brain synaptic function
CT1812 START study in early Alzheimer’s disease allows approved monoclonal antibody as background therapy – featured as late-breaking, oral presentation
Cognition scientists and collaborators will present the complete electroencephalography (EEG) findings and proteomic analyses from the SEQUEL study. Prior topline results showed that CT1812 had a beneficial impact on synapse function as measured by a positive change in brain waves patterns observed using quantitative EEG. Specifically, participants treated with CT1812 exhibited fewer slow “theta” waves, which are associated with cognitive impairment, and proportionally more “alpha” waves compared to placebo-treated participants. CT1812 also improved connectivity, as assessed by alpha AECc, which may indicate improved communication between different parts of the brain.
An oral late-breaking presentation will also discuss the Phase 2 study design of the company’s ongoing START study, which is enrolling adults with early Alzheimer’s disease. Participants in START will be permitted to be on stable background therapy with lecanemab, an FDA-approved anti-amyloid antibody.
“The approval of monoclonal antibody therapies against amyloid beta (Aβ) protofibrils represents an important milestone in Alzheimer’s drug development, but industry experts agree that combination treatments will likely be required to achieve greater impact on the disease,” explained
Title: | A Pilot Electroencephalography (EEG) Study to Evaluate the Effect of CT1812 Treatment on Synaptic Activity in Subjects with Mild to Moderate Alzheimer's Disease (LP024) |
Authors: | De Haan W, Caggiano AO, Scheltens P, Grundman M, Scheijbeler E, Hamby ME, Vijverberg E |
Title: | Proteomic Analysis of Plasma in a Phase 2 Clinical Trial in Alzheimer’s Patients to Identify Pharmacodynamic Biomarkers of the S2R Modulator CT1812 (P075) |
Authors: | Lizama B, Cho E, Duong D, Pandey K, Williams C, Caggiano AO, Seyfried N, |
Title: | Proteomic Analysis in a Phase 2 Clinical Trial Studying CT1812 to Identify CSF and Plasma Pharmacodynamic Biomarkers and Molecular Correlates of EEG in Alzheimer’s Patients (LP057) |
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Title: | CT1812 START Study Design: Anti-Aβ Monoclonal Antibodies as Background Therapy (LB18) |
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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 Aβ oligomers, oxidative stress and other stressors. This damage to sensitive synapses can progress to a loss of synaptic function. CT1812 is currently in development for mild-to-moderate Alzheimer’s disease in the SHINE study (NCT03507790), early Alzheimer’s disease in the START study (NCT05531656), and dementia with Lewy bodies in the SHIMMER study (NCT05225415).
About the SEQUEL Study
The SEQUEL study enrolled 16 adults with mild-to-moderate Alzheimer’s disease (MMSE 18-26), each of whom were randomized to receive either CT1812 or placebo once daily for 28 days. After a 14-day wash-out period, participants cross over into the other treatment arm for an additional 28 days. SEQUEL was designed to assess the safety and efficacy of CT1812 and to measure the impact of CT1812 on the electrical activity in the brain, specifically those electrical impulses in the theta band. SEQUEL was supported by
About the START Study
The study will measure the efficacy and tolerability of once-daily oral CT1812 in individuals with mild cognitive impairment or early Alzheimer’s disease (MMSE 20-30) who have elevated Aβ (as measured by PET or CSF). Participants will be randomized to receive CT1812 or placebo for 18 months. The study will assess cognition and executive function using validated tools including the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales, as well as biomarker and safety findings.
The START study is supported by a grant from the
About
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