Elayta (zervimesine) / Cognition Therap - LARVOL DELTA

Cognition Therapeutics Extends Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies (GlobeNewswire) - "The program, which was originally expected to provide each participant with twelve months of treatment, will now allow several more months of treatment....Thirty-two individuals were enrolled at eight sites in this open-label EAP, each of whom are being treated with 100 mg of oral zervimesine daily. Banner Sun Health Research Institute in Arizona was the first site to be activated and enrolled the first participants....The EAP is part of the company’s larger clinical development program in DLB, which included the Phase 2 SHIMMER study and planned clinical programs."

Clinical • Dementia • Lewy Body Disease

Cognition Therapeutics Completes Type C Meeting with FDA for Zervimesine (CT1812) in Dementia with Lewy Bodies (GlobeNewswire) - "The objective of this meeting was to review plans for the proposed Phase 2b study of zervimesine in dementia with Lewy bodies (DLB), a disease with no FDA-approved therapies."

FDA event • New P2b trial • Dementia • Lewy Body Disease

A GLOBAL STATISTICAL TEST APPROACH TO CLINICAL TRIALS WITH ZERVIMESINE FOR DEMENTIA WITH LEWY BODIES (ADPD 2026) - "The proposed GST composite approach allows assessment of a general treatment effect in DLB without specifying a single-symptom primary outcome in patients displaying a multitude of symptoms. Future discussions with regulators may establish the acceptability of the GST approach for regulatory approval in DLB."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Mood Disorders • Movement Disorders

ZERVIMESINE SLOWS PROGRESSION OF SYMPTOMS IN MILD TO MODERATE DLB (ADPD 2026) - P2 | "Zervimesine was generally safe and tolerable with trends for slowing progression across all symptom domains with notable benefits observed for neuropsychiatric symptoms, memory related items and activities of daily living. Cognition Therapeutics will be meeting with FDA to discuss zervimesine DLB development plans."

Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Mood Disorders • Movement Disorders

Biomarkers. (PubMed, Alzheimers Dement) - P2 | "The correlates identified may represent an inflammatory signature tied to the decreased neuroinflammation (plasma-GFAP) with zervimesine in AD patients observed in the pTau217 biomarker-defined subgroup (below the median). Results support a role for zervimesine in decreasing neuroinflammation and the continued clinical development of zervimesine for AD."

Biomarker • Clinical • Journal • Alzheimer's Disease • CNS Disorders • Inflammation • GFAP • LAMP1

Drug Development. (PubMed, Alzheimers Dement) - "Results from the SHINE study provide compelling evidence that zervimesine has the potential to slow cognitive decline in patients with AD. Participants with lower disease burden, as measured by plasma p-tau217 experienced a more pronounced treatment effect. Importantly, this benefit was observed in people across the mild-to-moderate MMSE spectrum. While preliminary, these results suggest that having a lower disease burden as measured by plasma p-tau217 may provide a therapeutic window to still treat patients in the moderate MMSE range. SHINE was supported by a grant from the National Institute of Aging (R01AG058660)."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease

Drug Development. (PubMed, Alzheimers Dement) - P2 | "In a pre-specified subgroup exhibiting 95% slowing of cognitive impairment with zervimesine, we identified protein correlates of cognition related to amyloid biology, supporting zervimesine mechanism of action. Enriching the mITT analysis with correlates from this biomarker-defined patient population reinforced observations of immune response and synaptic pathways that correlate with cognition in both mITT and below-median pTau217 subgroup. These biomarker findings paired with positive clinical outcomes support the further clinical development of zervimesine for AD."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Drug Development. (PubMed, Alzheimers Dement) - "These data will allow comparison of the SHIMMER population to prior DLB study populations. SHIMMER results support the potential for zervimesine to slow clinical progression in patients with mild-to-moderate DLB. The robust therapeutic response observed across neuropsychiatric, cognitive, motor and functional measures is particularly encouraging. An analysis of participant characteristics will help guide recruitment in future clinical studies of zervimesine and its potential use to treat people with DLB. Cognition Therapeutics conducted COG1201 with University of Miami Miller School of Medicine and the Lewy Body Dementia Association under a grant from the National Institute of Aging (R01AG071643)."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease • Psychiatry

Phase 2 study of zervimesine (CT1812) in participants with mild-to-moderate dementia with Lewy bodies (DLB). (PubMed, Alzheimers Dement) - P2 | "This study evaluated the safety and efficacy of zervimesine in Lewy body dementia. The incidence of adverse events was comparable to zervimesine 100 mg and placebo. Favorable, consistent trends were observed with zervimesine for exploratory endpoints."

Clinical • Journal • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease

Alzheimer's Disease Pivotal Trial Design for Zervimesine Following an End of Phase 2 Meeting with FDA (CTAD 2025) - No abstract available

P2 data • Alzheimer's Disease • CNS Disorders

Cognition Therapeutics Reaches Full Enrollment in Expanded Access Program for Zervimesine (CT1812) in Dementia with Lewy Bodies (GlobeNewswire) - "Each of the individuals enrolled in the program are being treated with 100 mg of oral zervimesine daily for up to one year. The program was made possible through a generous donation from the family of a participant in the Phase 2 SHIMMER study of zervimesine (CT1812) in dementia with Lewy bodies (DLB)....The Company's request for a Type C meeting has been accepted by the U.S. Food and Drug Administration (FDA) and the meeting scheduled for the second half of January. The Type C meeting will focus on the proposed design of a Phase 3 program for zervimesine in this patient population. Meeting minutes are expected to follow the Type C meeting."

Enrollment closed • FDA event • New P3 trial • Dementia • Lewy Body Disease

Cognition Therapeutics Presents Phase 3 Plan for Zervimesine (CT1812) in Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference (GlobeNewswire) - "Seeking Alignment with European Medicines Agency (EMA) at February 2026 Meeting...The Phase 3 program is expected to enroll adults with mild-to-moderate Alzheimer's disease who have lower levels of plasma p-tau217 at screening...'Results from the Phase 2 ‘SHINE’ study showed that participants treated with zervimesine who had lower plasma p-tau217 levels experienced a 95% slowing of cognitive decline (by ADAS-Cog11) compared with placebo.'....FDA meeting minutes stated that two six-month Phase 3 studies with participants randomized 1:1 to receive either 100 mg of oral zervimesine or placebo daily may be sufficient. Efficacy may be measured using the iADRS, a composite of the ADAS-Cog 13 and ADCS-ADL, validated scales measuring cognition and function. Participants who complete either study will be eligible to enroll in an open-label extension."

European regulatory • New P3 trial • P2 data • Alzheimer's Disease

Cognition Therapeutics…announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START’ Study (GlobeNewswire) - "A number of additional patients are in the final stages of screening and will be randomized if they meet all eligibility requirements....Topline results are expected after all participants have completed 18 months of treatment."

P2 data • Trial status • Alzheimer's Disease

Cognition Therapeutics Reports Financial Results for the Third Quarter 2025 and Highlights Progress Across Clinical Programs (GlobeNewswire) - "Proposed registrational Alzheimer’s disease study design accepted for presentation at Clinical Trials in Alzheimer’s Disease (CTAD) Conference, being held December 1-4, 2025."

Clinical protocol • Alzheimer's Disease

START: A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=540 | Active, not recruiting | Sponsor: Cognition Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

Cognition Therapeutics Closes $30 Million Registered Direct Offering to Two New Fundamental Institutional Investors, Including a Preeminent Global Investment Firm to Support Phase 3 Development of Zervimesine (CT1812) (GlobeNewswire)

Financing • Alzheimer's Disease

Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Reaches 75% Enrollment Target (PRNewswire) - "The START Study is enrolling approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer’s disease who will be treated with zervimesine (CT1812) or placebo for 18 months."

Enrollment status • Alzheimer's Disease

Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in...Alzheimer’s Disease (GlobeNewswire) - P2 | N=153 | SHINE (NCT03507790) | Sponsor: Cognition Therapeutics | "Results from the Phase 2 COG0201 ‘SHINE’ study (NCT03507790) of zervimesine in Alzheimer’s disease were also presented at AAIC. The SHINE study met its primary endpoint of safety and tolerability. An analysis was conducted on a subgroup of participants whose Alzheimer’s disease brain pathology was less pronounced, as determined by lower levels of a protein called p-tau217 in their blood. Approximately half of this subgroup was identified as having mild Alzheimer’s disease and half with moderate Alzheimer’s disease by the mini mental state exam (MMSE)...SHINE participants with lower p-tau217 had a more robust response to zervimesine compared to those with higher p-tau217 levels regardless of their MMSE scores. Zervimesine was shown to arrest further cognitive deterioration in people with mild or moderate Alzheimer’s disease by 129% and 91%, respectively."

P2 data • Alzheimer's Disease

Cognition Therapeutics Completes End-of-Phase 2 Meeting with FDA for Zervimesine (CT1812) in Alzheimer’s Disease (GlobeNewswire) - "Cognition Therapeutics, Inc...conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and to discuss plans for a Phase 3 program that would support a new drug application (NDA) for zervimesine as a treatment for Alzheimer’s disease...'We discussed the results from the Phase 2 ‘SHINE’ Study in Alzheimer’s disease and our proposed Phase 3 plan with the FDA and believe we have a path forward for the development of zervimesine in the treatment of Alzheimer’s disease. We look forward to reviewing the FDA’s formal minutes in August to confirm our path forward.'"

FDA event • Alzheimer's Disease

Cognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer’s Disease (GlobeNewswire) - "FDA confirmed the proposed design of the Phase 3 program may support a New Drug Application (NDA) filing for zervimesine (CT1812)....The Phase 3 program is expected to enroll adults with a diagnosis of mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening....Cognition also plans to include biomarker and imaging assessments in the Phase 3 program..."

FDA event • New P3 trial • Alzheimer's Disease

Cognition Therapeutics' Positive Clinical Data from Zervimesine (CT1812) Phase 2 Study in Dementia with Lewy Bodies (DLB) will be Presented in a Podium Presentation at AAIC (GlobeNewswire) - "Cognition Therapeutics...announced that James E. Galvin, MD, MPH will present results from the Phase 2 ‘SHIMMER’ study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) during an oral presentation at the Alzheimer’s Association International Conference (AAIC). Dr. Galvin is director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the COG1201 SHIMMER study (NCT05225415) director. The presentation will take place on July 29, 2025....Results from the Phase 2 ‘SHINE’ study in people with Alzheimer’s disease add further evidence to zervimesine’s neuroprotective properties. We look forward to presenting results from both studies at AAIC....Cognition will present clinical efficacy results and new proteomic findings from this Alzheimer’s study at AAIC."

P2 data • Alzheimer's Disease • Dementia • Lewy Body Disease

Cognition Therapeutics Publishes Proteomic Analysis Elucidating Zervimesine’s Protection of Neurons and Synapses in Alzheimer’s Disease (GlobeNewswire) - P2 | N=16 | SEQUEL (NCT04735536) | Sponsor: Cognition Therapeutics | "Cognition Therapeutics...published results of a proteomics analysis from the Phase 2 ‘SEQUEL’ COG0202 Study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer's disease. The manuscript...was published in the peer-reviewed journal Alzheimer's & Dementia: Translational Research & Clinical Interventions....In the SEQUEL study (NCT04735536), zervimesine treatment resulted in consistent trends of improvement across all prespecified EEG parameters, including the prominence of certain EEG frequencies associated with Alzheimer’s disease. Slower frequencies termed 'theta' waves were reduced after 29 days of zervimesine treatment compared to placebo. This suggests zervimesine may normalize the function of neurons and synapses....In vitro experiments showing protection of neurons under disease conditions support proteomics biomarker analysis from phase 2 SEQUEL study."

Biomarker • P2 data • Alzheimer's Disease

Cognition Therapeutics Presents Data at AAIC Highlighting Broad Neurological Impact of Zervimesine (CT1812) in Dementia with Lewy Bodies... (GlobeNewswire) - P2 | N=130 | SHIMMER (NCT05225415) | Sponsor: Cognition Therapeutics | "Cognition...presented results from the Phase 2 COG1201 SHIMMER study (NCT05225415) of zervimesine (CT1812) in dementia with Lewy bodies (DLB) at the Alzheimer’s Association International Conference (AAIC 2025)...As previously reported, the SHIMMER study met its primary endpoint of safety and tolerability. Results showed that zervimesine treatment had a positive impact across neuropsychiatric, cognitive, motor, and functional scales. After six months of treatment, DLB patients treated with zervimesine scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI-12). This tool measures 12 separate behavioral symptoms, including hallucinations, delusions, and anxiety, which are hallmarks of DLB. The findings were presented by James E. Galvin, MD, MPH during a Featured Research Session on July 29, 2025."

P2 data • Dementia • Lewy Body Disease

Cognition Therapeutics Reports Financial Results for the Second Quarter 2025 and Highlights Progress Across Clinical Programs (GlobeNewswire) - "...'Later this month we anticipate receiving the FDA’s minutes from our end-of-Phase 2 meeting regarding registrational plans for zervimesine in Alzheimer’s disease. We expect these will confirm our understanding of the Agency's expectations for a clinical program in Alzheimer’s disease....In addition, we expect FDA will have a decision on breakthrough designation for zervimesine in DLB in the third quarter 2025'."

FDA event • Alzheimer's Disease • Dementia • Lewy Body Disease

Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Surpasses 50% Enrollment Target (GlobeNewswire) - "Cognition Therapeutics...announced that the Phase 2 ‘START’ Study surpasses 50% enrollment....The START Study (NCT05531656) is designed to enroll up to 540 individuals with mild Alzheimer’s disease who will be treated with zervimesine (CT1812) or placebo for 18 months. Participants are being enrolled at approximately 50 sites in the United States, including premier institutions in the ACTC network."

Enrollment status • Alzheimer's Disease