CT 1812 shows positive Phase II results in DLB

“The results from this exploratory Phase II trial demonstrated CT1812 could have a meaningful, positive impact on DLB patients across multiple measures of cognitive, behavioral, movement, and functional performance. DLB is a multifactorial disease where patients experience a constellation of symptoms, and the results of this study suggest CT1812 holds promise for DLB patients and their care providers,” stated James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and a principal investigator in the SHIMMER study. “I believe the SHIMMER topline results are both exciting and very promising, and I am looking forward to working with the team at Cognition as they determine the appropriate next steps for CT1812.”

Designed as a signal-finding study, the SHIMMER Phase II study enrolled 130 patients with mild-to-moderate DLB who were randomized to receive one of two oral doses of CT1812 or placebo daily for six months. Results indicate the study met its primary endpoint of safety and tolerability, with data showing that DLB patients treated with CT1812 for six months experienced improvement in behavioral, functional, cognitive and movement measures compared to placebo. Importantly, there was an 82% slowing in the total neuropsychiatric inventory (NPI) with particularly strong reduction in anxiety, hallucinations, and delusions in the CT1812 treated arms. In addition, there was a marked reduction in caregiver distress, which suggests a positive impact on the day-to-day lives of those receiving the drug. Participants treated with CT1812 experienced a slowing of decline across all three cognitive measures compared to placebo, including fluctuations in attention which declined by 91%.   Detailed data will be presented at the International Lewy Body Dementia Conference (ILBDC) in January 2025.

“These topline results exceeded our expectations and support the broad potential of CT1812 across neurodegenerative disorders,” stated Anthony Caggiano, M.D., Ph.D., Cognition’s chief medical officer and head of R&D. “Analysis of CT1812’s activity in DLB will continue as additional data become available. We look forward to reporting these findings at future medical meetings and reviewing them with the FDA in an end-of-Phase II meeting.”

“With the SHIMMER and SHINE results, we are confident in CT1812’s clinical activity given that it has demonstrated broad neurologic and neuroprotective activity in DLB and Alzheimer’s disease,” stated Lisa Ricciardi, Cognition’s president and CEO. “People with these diseases, particularly DLB, have few therapeutic options leading to a cascade of symptoms that are painful to the individual and their caregivers. We are eager to continue the development of CT1812 in late-stage clinical trials with the hope of providing a once-daily pill that can treat these devasting neurodegenerative conditions.”

About the SHIMMER Study
The SHIMMER study (NCT05225415) is an exploratory double-blind, placebo-controlled Phase II clinical trial that enrolled 130 adults with mild-to-moderate DLB. Participants are assessed throughout the study using the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism.