Commentary
Video
Assessing Investigational CT1812’s Impact on Tau, Amyloid, and Neurodegeneration: Mary Hamby, PhD
Author(s):
The vice president of research at Cognition Therapeutics gave clinical insight on several new analyses covering CT1812, an orally delivered small molecule oligomer antagonist, in patients with early-stage Alzheimer disease. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
"Seeing CT1812’s impact across multiple biomarkers, not just one, is very encouraging—it reinforces the potential for real clinical benefit in Alzheimer treatment."
The SHINE study (NCT03507790) is a double-blind, placebo-controlled phase 2 signal-finding trial that enrolled 153 adults with mild-to-moderate Alzheimer disease (AD) who were evenly randomized to either placebo or one of 2 doses of CT1812 (100 mg or 300 mg), which was taken orally for 6 months. Supported by 2 grant awards from the National Institute on Aging, the study used safety and tolerability as the primary end point, with secondary end points that included the Alzheimer’s Disease Assessment Cognitive subscale (ADAS-Cog11), and exploratory measures such as the Mini-Mental State Exam, ADAS-Cog13, ADCS-ADL, and Clinical Global Impression of Change.
At the 2025 AD/PD International Conference on Alzheimer’s and Parkinson’s Diseases, held April 1-5 in Vienna, Austria, Cognition Therapeutics presented several different analyses of the drug, including subgroup findings from SHINE. The main presentation, a talk given by Mary Hamby, PhD, focused on the positive impacts of the agent on plasma biomarkers in a subgroup of patients with lower phosphorylated tau (p-tau)217. In addition, other analyses focused on cerebrospinal fluid (CSF) proteomic biomarkers, correlations between CSF proteins and cognitive outcomes, and the change in neurofilament light, a biomarker of neuroaxonal damage.
During the conference, Hamby, vice president of research at Cognition Therapeutics, sat down with NeurologyLive® to discuss the data, highlighting the drug’s promising cognitive and biomarker effects. In addition, she gave clinical insights on the plasma biomarker findings, noting that while the intent-to-treat population showed little change, the low tau group exhibited significant reductions in notable biomarkers of neurodegenerative disease. Furthermore, she provided additional clarity on the exploratory proteomic analysis, emphasizing how these findings advance a biomarker-driven approach to AD trials.
