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By Meg Flippin, Benzinga
When it comes to the many different types of dementia, dementia with Lewy bodies (DLB) is among the most challenging. It’s a progressive form of dementia with symptoms that can appear quickly and fluctuate in severity, often delaying proper diagnosis.
DLB leads to a decline in thinking, reasoning and independence. It can cause involuntary changes in alertness, recurring hallucinations, sleep disruptions, tremors and slow movement. It impacts an estimated 1.4 million people in the U.S. and is the costliest form of dementia. This high cost is driven by complex symptoms requiring intensive medical care and caregiving, including frequent hospitalizations due to falls and other complications.
A big problem with DLB is how difficult it is to diagnose and treat. Diagnosis can take up to 18 months and often requires visits with multiple specialists. Overlapping symptoms with Parkinson's disease further complicates diagnosis, as clinicians must determine whether cognitive or physical symptoms appeared first. While off-label drugs can help manage some symptoms, there are no approved treatments to slow or reverse the disease. The average survival rate after symptom onset is five to eight years.
DLB In Need Of New Treatments
DLB’s complexity and impact on patients and caregivers underscores the need for better treatments. This unmet need has driven projections for the DLB market to reach $8.45 billion by 2033, growing at a CAGR of 6%.
Cognition Therapeutics Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, is hoping CT1812, its orally delivered small molecule oligomer antagonist, holds the answer.
CT1812 is designed to protect neurons in the brain from damaging proteins, targeting toxic oligomers associated with both DLB and Alzheimer’s disease. A large percentage of DLB patients have both Aβ and α-synuclein oligomers present in the brain. The company says that by preventing the buildup of these toxic proteins, CT1812 is differentiated from other approved and developing dementia treatments by its ability to target two different toxic proteins: Aβ, which drives Alzheimer’s disease, and α-synuclein, which is implicated in dementia with Lewy bodies.
Notably, 50-80% of DLB patients have both types of toxic proteins present in their brains, making CT1812 uniquely positioned to address this overlapping pathology, Cognition Therapeutics says. If approved, the company believes daily, oral CT1812 represents a treatment paradigm shift from invasive and burdensome to convenient and accessible.
Key Phase 2 Clinical Trial Nearing Data Readout
Cognition expects a key data readout by year-end for its phase 2 SHIMMER clinical trial, which tested CT1812 in mild-to-moderate DLB. The double-blind, placebo-controlled study enrolled 130 adults randomized to receive either a placebo or one of two daily doses of CT1812 (100 mg or 300 mg) for six months. Participants are assessed throughout the study using the Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE), 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.
SHIMMER evaluates a broad spectrum of DLB symptoms to capture the individualized nature of disease progression and treatment response. Success will be measured by clinical signals across these cognitive and functional outcomes. For a devastating neurodegenerative disease like DLB, where researchers have not been able to find solutions, a positive efficacy signal would be extremely promising news for patients and investors alike, the company argues.
The SHIMMER study is supported by a $30 million grant from the National Institute on Aging and the National Institute of Health, 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.
In late November, Cognition announced the last patient completed their final clinic visit. The company expects topline results to be available later in December. “We look forward to reviewing the results of this study to enhance our understanding of CT1812’s tolerability profile and identify signals of efficacy across measures of cognition and function in DLB,” said Lisa Ricciardi, Cognition’s president and CEO.
“If successful, this would be the second major neurodegenerative condition for which CT1812 has demonstrated a favorable clinical outcome, following recent data where CT1812 dramatically slowed cognitive decline in patients with lower levels of pTau217, an important biomarker of Alzheimer’s disease. Taken together, we could have an opportunity to advance CT1812 in multiple neurodegenerative conditions, significantly broadening its impact and revenue opportunities,” she said.
Despite how many Americas are affected by DLB, there are no approved treatments for symptoms or altering disease progression. Cognition Therapeutics wants to change that with CT1812. If the clinical trial backs up its thesis, Cognition hopes to be the first to market with a drug that can alter the course of this devastating disease.
To learn more about Cognition Therapeutics and its SHIMMER study, click here.
Featured photo by Robina Weermeijer on Unsplash.
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