Topline Results Are In: Cognition Therapeutics' Drug To Fight Dementia With Lewy Bodies Shows Encouraging Results In Phase 2 Trial

Cognition Therapeutics Inc. CGTX, a clinical-stage company developing drugs that treat neurodegenerative disorders including dementia with Lewy bodies (DLB), announced positive topline results of its exploratory phase 2 SHIMMER study for CT1812, its experimental orally delivered small molecule oligomer antagonist to treat this progressive form of dementia.

Cognition Therapeutics said the trial demonstrated CT1812 produced strong therapeutic responses across behavioral, functional, cognitive and movement measures in patients with DLB. DLB is a form of dementia in which symptoms come on fast. DLB can quickly lead to a decline in thinking and reasoning as well as independent movements, and can cause uncontrollable changes in alertness, recurring hallucinations, sleep disruptions, tremors and slow movement. It impacts about 1.4 million people in the U.S. and is the costliest form of dementia. As it stands, drugs to cure this debilitating form of dementia are nonexistent, and treatments, which are used off-label focus on managing symptoms.

Promise In A Pill 

"These topline results exceeded our expectations and support the broad potential of CT1812 across neurodegenerative disorders," Anthony Caggiano, M.D., Ph.D., Cognition's chief medical officer and head of R&D, said when announcing the results. "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 2 meeting."

The phase 2 SHIMMER study enrolled 130 adults who were randomized to receive either placebo or one of two oral once-daily doses of CT1812 (100 mg or 300 mg) for six months. Participants were assessed throughout the study using the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research (CDR) Battery, 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. 

Cognition Therapeutics said 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 the placebo. Cognition reported an 82% slowing in the total neuropsychiatric inventory (NPI), with a 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, reports the company. Participants treated with CT1812 experienced a slowing of decline across all three cognitive measures compared to the placebo, including fluctuations in attention which declined by 91%. Cognition plans to present detailed data at the International Lewy Body Dementia Conference (ILBDC) in January 2025.

The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million and is being conducted in collaboration with the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). 

Preceding Trial Had Promising Results 

Cognition had previously completed a Phase 2 SHINE study to look at CT1812's effects on treating individuals aged 50 to 85 who have mild-to-moderate Alzheimer's disease. That study recruited 153 individuals, and the results showed a 95% slowing of cognitive decline in people exhibiting a key Alzheimer's disease biomarker.

"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," Lisa Ricciardi, Cognition's president and CEO, said. "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 devastating neurodegenerative conditions." 

To learn more about Cognition Therapeutics and its SHIMMER study, click here. 

Featured photo by Rad Cyrus on Unsplash.

This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice.