Cognition Therapeutics Receives Second Philanthropic Donation to Extend Ongoing Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies

Cognition Therapeutics Extends Zervimesine EAP for DLB Patients

Cognition Therapeutics announced a second philanthropic donation from Mr. Jeffrey Pechter, enabling the extension of its ongoing expanded access program (EAP) for zervimesine (CT1812) in dementia with Lewy bodies (DLB). This donation allows the 32 enrolled participants to receive two years of treatment with the once-daily oral investigational therapy. The EAP, launched in 2025, follows positive findings from the Phase 2 SHIMMER study, and the company plans to meet with the FDA in Q2 2026 to discuss a registrational program for zervimesine in DLB psychosis.

• Cognition Therapeutics has secured a second philanthropic donation from Mr. Jeffrey Pechter of Mindful Capital, extending its expanded access program (EAP) for zervimesine in dementia with Lewy bodies (DLB). This new funding ensures that the 32 participants currently enrolled in the open-label EAP (COG1202) will receive two years of treatment with the investigational therapy.
• The EAP, which began in 2025 with initial funding from a DLB patient's family, provides 100 mg of once-daily oral zervimesine to eligible individuals, including former participants from the Phase 2 SHIMMER study. Dr. James E. Galvin of the University of Miami Miller School of Medicine serves as the lead investigator, highlighting the program's importance given the limited treatment options for DLB.
• Following positive results from the completed Phase 2 SHIMMER study, Cognition Therapeutics is scheduled to meet with the FDA Division of Psychiatry in the second quarter of 2026. This meeting aims to discuss the next steps for a registrational program evaluating zervimesine for DLB psychosis, indicating the company's intent to advance the therapy towards potential approval.

Addressing the Critical Unmet Needs in Dementia with Lewy Bodies

Recent research has identified multiple critical gaps in dementia with Lewy bodies (DLB) care and treatment, despite it being the second most common neurodegenerative dementia. The field faces significant challenges across diagnosis, treatment, and patient support, driving targeted research efforts in specific populations and therapeutic approaches.

• Absence of FDA-approved therapies - DLB has no approved disease-modifying treatments, with clinical trials showing limited ability to demonstrate efficacy due to lack of validated DLB-specific clinical trial outcomes

• Diagnostic accuracy challenges - DLB remains underdiagnosed and misdiagnosed with significant diagnostic delay compared to other dementias, particularly in regions like Latin America where only 0.6% of memory clinic patients received DLB diagnosis

• Disease progression prediction - Baseline clinical symptoms fail to predict decline in cognition, everyday functioning, and quality of life, though underlying pathology markers show more predictive value

• Caregiver burden and support gaps - Individuals with DLB have higher likelihood of requiring live-in migrant caregivers (OR=2.31) and exhibit higher neuropsychiatric symptom scores, yet no evidence-based support services exist specifically for LBD carers

• Limited symptomatic treatment options - Current cholinesterase inhibitors and memantine provide only symptomatic benefits, while psychotropic medications show minimal efficacy and carry significant risks including increased mortality and cognitive decline

• Biomarker and outcome measure development - Critical need exists for DLB-specific biomarkers and clinical trial endpoints, with disrupted mitochondrial supercomplex formation showing promise as a potential biomarker correlating with disease progression

• Genetic counseling and testing gaps - GBA1 mutations associate with reduced survival in DLB (HR=1.999), creating urgent need for clinician education on genetic testing and counseling for patient stratification and clinical trial inclusion

• Assessment tool limitations - Capability measures place higher cognitive demands on DLB patients compared to other dementias, with 57.4% comprehension error rates versus 42.9% in Alzheimer's disease, necessitating dementia subtype-specific validation

• Prodromal stage identification - Mild cognitive impairment with Lewy bodies (MCI-LB) represents a key target population, with 55% progressing to DLB within 3 years and probable MCI-LB classifications showing 91% sensitivity and 94% specificity

• Diverse population representation - Research efforts target improved global and diverse population inclusion, with current studies predominantly focusing on male patients (76%) with average age 72.3 years and specific populations like Ashkenazi Jews for genetic studies

Zervimesine's Promising SHIMMER Results and Path to Registrational Program

Recent clinical studies in dementia with Lewy bodies have explored diverse therapeutic approaches, ranging from repurposed tyrosine kinase inhibitors to electroconvulsive therapy. These investigations provide important insights into potential treatment options for this challenging neurodegenerative condition.

• Nilotinib study (2025) - A phase 2, randomized, double-blind trial of 43 participants treated with nilotinib 200 mg daily for 6 months demonstrated favorable safety and tolerability with fewer adverse events versus placebo (37 vs 74, p=0.054) and significantly reduced falls (6 vs 21, p=0.006). Efficacy outcomes showed increased cerebrospinal fluid homovanillic acid (p=0.004), reduced pTau181/Aβ42 ratio (p=0.034), and improved cognition on ADAS-cog14 by 2.8 points (p=0.037) and MDS-UPDRS part I (p=0.044).

• Vodobatinib (K0706) study (2025) - A single-center, double-blind study of 29 participants randomized to vodobatinib 192 mg, 384 mg, or placebo for 3 months showed good safety with fewer adverse events in active treatment groups and reduced falls (6 and 0 versus 28 in placebo). The primary efficacy signal was significant changes in CSF Aβ42/Aβ40 ratio in both dose groups (p=0.0002 and p=0.0121), though no differences were observed in homovanillic acid or clinical outcomes.

• Electroconvulsive therapy study (2026) - A retrospective analysis of 40 LBD patients receiving ECT between 2012-2023 demonstrated good safety with no serious adverse events and only transient amnesia as the primary side effect. Short-term efficacy was comparable to schizophrenia patients (median CGI-I: 2), with psychosis and catatonia predicting favorable response, though 2-year psychiatric readmission rates were highest in LBD at 61.5%.

Zervimesine's EAP Extension Signals Strategic Push in DLB

The recent announcement regarding the extension of zervimesine's expanded access program (EAP) in dementia with Lewy bodies (DLB) marks a pivotal moment for Cognition Therapeutics and the broader neurodegenerative field. This philanthropic support enables 32 participants to continue receiving the investigational therapy for two years, providing invaluable long-term data in a real-world setting. This move is particularly significant given the substantial unmet need in DLB, a condition characterized by debilitating cognitive impairment and psychosis, for which effective disease-modifying or symptomatic treatments are scarce.

Zervimesine, an orally dosed sigma-2 receptor modulator, has shown promise in preclinical and early clinical studies for Alzheimer's disease by displacing amyloid beta oligomers and improving synaptic function. The positive findings from the Phase 2 SHIMMER study in DLB, coupled with the company's intent to discuss a registrational program with the FDA in Q2 2026, suggest a strategic acceleration for this therapy in a challenging indication. This could position zervimesine as a frontrunner in addressing DLB psychosis, potentially offering a new therapeutic avenue where current options are limited.

However, the path forward is not without its complexities. While EAPs provide crucial access and generate observational data, they do not substitute for the rigorous, controlled trials required for regulatory approval. The inherent challenges in developing novel neurodegenerative therapeutics are well-documented, and even promising candidates face high attrition rates. Therefore, the success of a future registrational program will hinge on demonstrating robust efficacy and a favorable safety profile in a larger, controlled setting. The transition from promising Phase 2 data and EAP insights to a definitive Phase 3 outcome will be critical in determining zervimesine's ultimate impact on patients living with DLB.