Cognition Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cognition Therapeutics (CGTX).
Over the past two years, Cognition Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CT1812. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CT1812 FDA Regulatory Timeline and Events
CT1812 is a drug developed by Cognition Therapeutics for the following indication: Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CT1812
- Announced Date:
- May 21, 2026
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, conducted a planned meeting with the U.S. Food and Drug Administration (FDA) on May 20, 2026. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and discuss the design and endpoints of a registrational study in dementia with Lewy bodies (DLB) patients with psychosis.
AI Summary
Cognition Therapeutics held a planned meeting with the U.S. Food and Drug Administration on May 20, 2026, to discuss the next step for zervimesine, also known as CT1812. The company and the FDA reviewed results from the Phase 2 study and talked about the design and key endpoints for a future registrational study in patients with dementia with Lewy bodies who also have psychosis.
The meeting was described as positive and helped support the path forward for the program. In addition, the USAN Council adopted zervimesine as the United States Adopted Name for CT1812, giving the drug candidate its formal nonproprietary name.
Read Announcement- Drug:
- CT1812
- Announced Date:
- March 17, 2026
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, presented an analysis from the Phase 2 COG1201 SHIMMER study (NCT05225415) of zervimesine (CT1812) in dementia with Lewy bodies (DLB) at the AD/PD™ 2026 Alzheimer's & Parkinson's Diseases Conference.
AI Summary
Cognition Therapeutics presented results from the Phase 2 COG1201 SHIMMER study (NCT05225415) at the AD/PD 2026 conference showing zervimesine (CT1812) slowed decline on the NPI-12 by 86% versus placebo in people with mild-to-moderate dementia with Lewy bodies (DLB). The NPI-12 measures neuropsychiatric symptoms, and the company says this large slowing of decline supports a unique disease‑modifying mechanism rather than only treating individual symptoms.
The company highlighted that acute antipsychotic treatments may ease one symptom but do not slow disease progression, while zervimesine may both slow DLB progression and reduce worsening of hallucinations, delusions, agitation, and anxiety. Posters from Grundman, Galvin, Iaci and colleagues at AD/PD will be posted on Cognition Therapeutics’ website per the conference embargo. The USAN Council has adopted zervimesine as the United States Adopted Name for CT1812.
Read Announcement- Drug:
- CT1812
- Announced Date:
- February 5, 2026
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, has extended the duration of the expanded access program (EAP) for dementia with Lewy bodies (DLB).
AI Summary
Cognition Therapeutics has extended the duration of its expanded access program (EAP) for dementia with Lewy bodies (DLB). The EAP was originally expected to provide each participant with twelve months of treatment, but will now allow several more months of therapy. The open-label program treats participants with 100 mg of oral zervimesine daily and is intended to give patients continued access to the investigational medicine while the company advances its clinical work.
Thirty-two people are enrolled across eight sites. Banner Sun Health Research Institute in Arizona was the first site activated and enrolled the initial participants. David Shprecher, DO, Msci, is the primary investigator at Banner and provided feedback to Cognition during the EAP’s design. The program is part of Cognition’s broader DLB development plan, which includes the Phase 2 SHIMMER study and other planned clinical programs.
Read Announcement- Drug:
- CT1812
- Announced Date:
- January 27, 2026
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, Inc., a clinical stage company developing drugs that treat neurodegenerative disorders, conducted a Type C meeting with the U.S. Food and Drug Administration (FDA) on January 21, 2026.
AI Summary
Cognition Therapeutics, Inc. held a Type C meeting with the U.S. Food and Drug Administration (FDA) on January 21, 2026, to review plans for a proposed Phase 2b study of zervimesine in dementia with Lewy bodies (DLB), a condition with no FDA‑approved therapies. The meeting concentrated on study design and which clinical measures would be meaningful for people with mild‑to‑moderate DLB.
Anthony O. Caggiano, MD, PhD, Cognition’s chief medical officer, said the discussion was productive. The company and FDA talked about clinically meaningful endpoints and other key elements of the Phase 2b plan. Cognition expects to receive official meeting minutes later this quarter and will continue discussions with the agency to advance clinical development in DLB.
Zervimesine (CT1812) is an investigational oral, once‑daily pill for central nervous system diseases. It has shown the ability to interfere with toxic effects of Aβ and α‑synuclein proteins that damage neurons and has been generally well tolerated in studies so far. The USAN Council has adopted “zervimesine” as the United States Adopted Name for CT1812.
Read Announcement- Drug:
- CT1812
- Announced Date:
- January 6, 2026
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, Inc. announced that a manuscript entitled, "Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB)" (doi: 10.1002/alz.71004) has been published in the journal, Alzheimer's & Dementia, the journal of the Alzheimer's Association. Results from this study were first presented in January 2025 at the International Lewy Body Dementia Conference in Amsterdam.
AI Summary
Cognition Therapeutics announced that a manuscript titled "Phase 2 Study of Zervimesine (CT1812) in Participants with Mild-to-Moderate Dementia with Lewy Bodies (DLB)" (doi: 10.1002/alz.71004) was published in Alzheimer’s & Dementia. Results from the study were first presented in January 2025 at the International Lewy Body Dementia Conference in Amsterdam.
The Phase 2 SHIMMER trial randomized 130 adults with mild-to-moderate DLB to daily oral zervimesine or placebo for six months. The study met its primary goal of confirming safety and tolerability. After six months, people treated with zervimesine showed greater improvements than placebo on the Neuropsychiatric Inventory (NPI), which tracks symptoms like hallucinations, delusions, anxiety, and agitation. Zervimesine also reduced cognitive fluctuations and improved activities of daily living and motor measures compared with placebo.
Most treatment-related side effects were mild or moderate. The published report (Galvin et al., Alzheimer’s Dement. 2025;21:e71004) supports further clinical study of zervimesine for DLB.Read Announcement
- Drug:
- CT1812
- Announced Date:
- November 13, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START' Study. A number of additional patients are in the final stages of screening and will be randomized if they meet all eligibility requirements.
AI Summary
Cognition Therapeutics announced it has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 START study. A number of additional patients are in the final stages of screening and will be randomized if they meet all eligibility requirements. START will test the safety and activity of zervimesine (CT1812) in people with mild cognitive impairment or early Alzheimer’s disease. Topline results are expected after all participants complete 18 months of treatment.
The company said strong interest from patients and investigators drove rapid enrollment, with roughly half of the study population enrolled in the last six months. Cognition thanked its partners and study sites for their work in meeting the enrollment goal.
Cognition’s chief medical officer noted zervimesine is an oral therapy with a favorable safety profile and no expected need for serial brain imaging. The company believes the drug could become an important option for patients with early, mild, or moderate Alzheimer’s disease if results are positive.
Read Announcement- Drug:
- CT1812
- Announced Date:
- September 3, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the Phase 2 ‘START' Study has reached the 75% enrollment mark.
AI Summary
Cognition Therapeutics announced that its Phase 2 START Study has reached 75% enrollment. The trial is testing an oral drug, zervimesine (CT1812), in about 540 people with mild cognitive impairment and early Alzheimer’s disease. Participants will receive either the drug or a placebo once daily for 18 months.
The study is run in partnership with the Alzheimer’s Clinical Trials Consortium and funded by the National Institute on Aging. It will measure shifts in cognition and executive function using tools like the Clinical Dementia Rating Scale and ADAS-Cog. Biomarkers and safety data will also be evaluated.
Lisa Ricciardi, Cognition’s president and CEO, said strong enrollment is driven by interest in a convenient, once-daily oral treatment. This START Study is the company’s largest Phase 2 trial and comes after earlier positive findings. Cognition aims to learn how zervimesine may help at different stages of Alzheimer’s disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- August 12, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that it has received final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the end-of-Phase 2 meeting that was conducted on July 9, 2025.
AI Summary
Cognition Therapeutics, Inc. announced it received the final minutes from the U.S. Food and Drug Administration following an end-of-Phase 2 meeting on July 9, 2025. The FDA confirmed that the proposed Phase 3 design for zervimesine (CT1812) could support a New Drug Application filing for Alzheimer’s disease.
Based on FDA feedback, the Phase 3 program will enroll adults with mild-to-moderate Alzheimer’s who have lower plasma p-tau217 levels at screening. Previous data showed zervimesine slowed cognitive decline by 95% versus placebo in this subgroup, highlighting p-tau217 as a predictive biomarker.
The FDA agreed to enrich the study population using a simple blood test for p-tau217, a move expected to boost study power, reduce costs, and lessen patient burden. Participants will be randomized to 100 mg of oral zervimesine or placebo daily for six months, with endpoints affirmed by the FDA.
Cognition also plans biomarker and imaging assessments and will offer an open-label extension to study completers. The FDA’s view that two six-month Phase 3 trials may support an NDA could speed enrollment and filing.
Read Announcement- Drug:
- CT1812
- Announced Date:
- July 29, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, 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).
AI Summary
Cognition Therapeutics, Inc. presented Phase 2 COG1201 SHIMMER results for zervimesine (CT1812) in dementia with Lewy bodies (DLB) at AAIC 2025. The exploratory trial enrolled 130 adults with mild-to-moderate DLB randomized to two doses of zervimesine or placebo over six months. The study met its primary endpoint of safety and tolerability. Participants on zervimesine showed benefits across neuropsychiatric, cognitive, motor, and functional scales. Specifically, treatment led to an 86% improvement on the Neuropsychiatric Inventory (NPI-12) compared with placebo.
James E. Galvin, MD, MPH, presented the findings, highlighting that improvements in hallucinations, delusions, and anxiety—symptoms often hard to treat in DLB—were especially notable. Zervimesine’s impact is encouraging because conventional treatments can cause severe side effects in DLB patients. These results support further studies of zervimesine as a potential new therapy for managing challenging behavioral symptoms in dementia with Lewy bodies.
Read Announcement- Drug:
- CT1812
- Announced Date:
- July 21, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, Inc. 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.
AI Summary
Cognition Therapeutics recently published results from an exploratory proteomics analysis of cerebrospinal fluid in its Phase 2 “SHINE” (COG0202) study of zervimesine (CT1812) in adults with mild-to-moderate Alzheimer’s disease. Using advanced mass-spectrometry methods, researchers measured changes in dozens of proteins in patients’ CSF samples, focusing on those with lower baseline levels of phosphorylated tau217 (p-tau217).
The analysis identified a set of synaptic and inflammatory biomarkers whose shifts correlated strongly with cognitive improvements on the ADAS-Cog 11 scale. In the low p-tau217 subgroup, zervimesine treatment slowed cognitive decline by about 95% at six months compared to placebo. These protein changes suggest zervimesine may protect nerve cells and support synaptic function.
These proteomic findings, together with clinical improvements in memory and daily living activities, will be presented at the Alzheimer’s Association International Conference. The data offer new insight into zervimesine’s mechanism and may guide personalized treatment strategies for Alzheimer’s disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- July 16, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, Inc., 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).
AI Summary
Cognition Therapeutics, Inc. announced that James E. Galvin, MD, MPH, will share key findings from the Phase 2 SHIMMER study of zervimesine (CT1812) in treating dementia with Lewy bodies (DLB). Dr. Galvin, who directs the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, led the trial. The results indicate that zervimesine, taken once daily, may help slow the progression of DLB by reducing troublesome symptoms such as hallucinations, fluctuating cognition, and movement issues. These promising results offer hope to the many people affected by DLB, which is the second most common cause of dementia in the United States. The findings will be presented orally during a featured research session at the Alzheimer’s Association International Conference (AAIC) on July 29, 2025.
Read Announcement- Drug:
- CT1812
- Announced Date:
- July 10, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, Inc., announced that it conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025.
AI Summary
On July 9, 2025, Cognition Therapeutics, Inc. held an important end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). During the meeting, the company reviewed key results from its Phase 2 study of zervimesine (CT1812), a drug candidate being developed to treat Alzheimer’s disease. The discussion focused on the data gathered from the study and the details of the proposed Phase 3 clinical trial program, which is intended to support a new drug application for zervimesine.
This FDA meeting was a crucial step for Cognition Therapeutics as it provided the company with valuable regulatory feedback on their clinical plans. The company is now preparing for the next phase of development while awaiting the official minutes from the FDA in August, which will confirm the pathway forward for zervimesine’s future testing and potential use in Alzheimer’s treatment.
Read Announcement- Drug:
- CT1812
- Announced Date:
- June 25, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the company will conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025.
AI Summary
Cognition Therapeutics, Inc. announced that it will conduct an important end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. This meeting is a key milestone for the company as it assesses the progress of its Phase 2 ‘SHINE’ study evaluating the investigational drug zervimesine (CT1812) in patients with mild-to-moderate Alzheimer’s disease.
At this meeting, the Cognition team will review the study results and discuss the proposed plans for a Phase 3 program aimed at securing regulatory approval for zervimesine. This discussion underscores the company’s commitment to advancing its clinical development efforts and exploring promising treatment options for neurodegenerative disorders. The outcome of this meeting may play a crucial role in shaping the future development of zervimesine for Alzheimer’s disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- June 3, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics announced today it has received an anonymous philanthropic donation to substantially fund an expanded access program (EAP) for people with dementia with Lewy bodies (DLB).
AI Summary
Cognition Therapeutics has received a generous anonymous donation from the family of a dementia with Lewy bodies (DLB) patient who participated in their Phase 2 SHIMMER study. This philanthropic gift will substantially fund an expanded access program (EAP) to offer zervimesine as an investigational treatment to DLB patients. Under the program, eligible patients will receive a daily dose of 100 mg of oral zervimesine for about one year. Banner Sun Health Research Institute in Arizona is the first of eight sites to open under this initiative, with Dr. Shprecher leading the site’s efforts. The donation not only supports the rapid launch of the EAP but also demonstrates a strong commitment to providing promising treatment options for people with DLB. By accelerating access to zervimesine, Cognition Therapeutics aims to make a meaningful impact on patient care and improve the quality of life for those affected by this challenging disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- May 8, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, reported topline results today from the Phase 2 COG2201 ‘MAGNIFY' trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD).
AI Summary
Cognition Therapeutics today announced topline results from its Phase 2 MAGNIFY trial of zervimesine (CT1812) in adults with geographic atrophy (GA) caused by dry age-related macular degeneration. The trial showed that patients taking zervimesine experienced a 28.6% slower increase in GA lesion growth compared to those on placebo. In addition, at 18 months, the GA lesion area in zervimesine-treated patients was 28.2% smaller than in the placebo group. These results suggest that zervimesine, a once-daily oral pill, could offer a convenient alternative to the regular clinic visits needed for injectable treatments. The study, which enrolled about 100 participants, supports the potential for zervimesine to slow disease progression in dry AMD and possibly improve treatment options for patients who are not suited for injections.
Read Announcement- Drug:
- CT1812
- Announced Date:
- April 1, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, presented biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria.
AI Summary
Cognition Therapeutics presented new biomarker findings from its Phase 2 SHINE (COG0201) study of zervimesine in patients with mild-to-moderate Alzheimer’s disease. The results were highlighted at the AD/PD™ 2025 Alzheimer’s & Parkinson’s Diseases Conference in Vienna, Austria. Dr. Mary Hamby, VP of research, explained that the study compared changes in key proteins in the overall study group with those in a subgroup that initially had lower levels of the Alzheimer’s-related protein p-Tau217. Participants treated for six months with zervimesine showed a reduction in plasma biomarkers linked to Alzheimer’s disease. In particular, significant decreases in glial fibrillary acidic protein (GFAP) and neurofilament light (NfL) were observed. These findings suggest that zervimesine may reduce neuroinflammation and neurodegeneration, supporting its potential as a treatment option for Alzheimer’s disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- March 25, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria.
AI Summary
Cognition Therapeutics will present important biomarker results from its Phase 2 SHINE (COG0201) study at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference. The study focused on using zervimesine (CT1812) to treat patients with mild-to-moderate Alzheimer's disease. During the conference, Mary Hamby, Ph.D., the company’s VP of research, will give a podium presentation detailing the analysis of key biomarkers collected from blood samples. These biomarkers include neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), amyloid beta (Aβ), and tau species such as p-Tau217 and p-Tau218, all of which are linked to Alzheimer's disease progression.
The presentation will highlight how changes in these biomarkers in patients treated with zervimesine compare to those in patients given a placebo, adding to the understanding of the drug's potential benefits in battling Alzheimer's disease.
Read Announcement- Drug:
- CT1812
- Announced Date:
- March 20, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, provided a business update.
AI Summary
Cognition Therapeutics recently provided a business update along with its financial results for the fourth quarter and full year ended December 31, 2024. The company, which develops therapies for neurodegenerative disorders, shared that it is shifting its focus in 2025. It has concluded enrollment in its Phase 2 dry AMD study to concentrate on its planned registrational programs for Alzheimer’s disease and dementia with Lewy bodies (DLB). The update highlighted the encouraging Phase 2 data for its lead candidate, zervimesine (CT1812), which demonstrated the potential to slow cognitive decline. Looking ahead, Cognition Therapeutics plans to hold separate end-of-Phase 2 meetings with the FDA to discuss Phase 3 clinical protocols for both Alzheimer’s and DLB. Additionally, the company is reviewing options for funding its upcoming trials, including potential partnering opportunities with pharmaceutical firms to support continued clinical development.
Read Announcement- Drug:
- CT1812
- Announced Date:
- February 26, 2025
- Target Action Date:
- Q2 2025
- Estimated Target Date Range:
- April 1, 2025 - June 30, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that Full Analysis will be Provided in the Second Quarter of 2025
AI Summary
Cognition Therapeutics, Inc. recently shared important results from its Phase 2 MAGNIFY study on zervimesine for patients with geographic atrophy from dry age-related macular degeneration. A masked futility analysis showed that participants treated with zervimesine for at least six months had a slower lesion growth rate compared to those on placebo. The study enrolled 100 participants but was ended early in order to conserve financial resources. All participants are expected to complete their final clinic visits in February 2025, after which the study data will be unblinded.
Cognition Therapeutics announced that a full analysis, including data from 12 months of dosing, will be provided in the second quarter of 2025. This upcoming analysis will offer further insights into zervimesine’s potential to alter disease progression in dry age-related macular degeneration.
Read Announcement- Drug:
- CT1812
- Announced Date:
- February 26, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, reported a positive outcome of an analysis of masked data from the ongoing ‘MAGNIFY' Phase 2 trial of zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD).
AI Summary
Cognition Therapeutics announced a positive outcome from a masked futility analysis of their ongoing MAGNIFY Phase 2 trial. The study is evaluating the investigational drug zervimesine (also known as CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). Data from the first 57 participants who received at least six months of dosing revealed that patients treated with zervimesine experienced a slower rate of lesion growth compared to those on placebo.
The analysis, conducted by an independent contract research organization, was designed to assess early signals of efficacy while maintaining the trial’s integrity. The full unblinded results, including data after 12 months of dosing, are expected in the second quarter of 2025. These early findings support the potential of zervimesine to affect the underlying biological processes of dry AMD.
Read Announcement- Drug:
- CT1812
- Announced Date:
- February 20, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the American Chemical Society journal Organic Process Research & Development has published a manuscript describing the novel chemical process used to manufacture zervimesine (CT1812).
AI Summary
Cognition Therapeutics announced that the American Chemical Society journal Organic Process Research & Development published a manuscript detailing a novel chemical process to manufacture zervimesine (CT1812). This new process uses innovative methods such as high throughput screening and light-induced continuous flow processing to create the drug in a more efficient and safer way. It also led to the discovery of a unique polymorphic form of zervimesine, which has improved room temperature stability, meaning it can have a longer shelf life.
This breakthrough is an important step in producing enough drug material for future clinical studies and, if approved, for commercial manufacturing. Provisional patent applications have been filed to protect both the chemical process and the preferred crystal form of zervimesine.
Read Announcement- Drug:
- CT1812
- Announced Date:
- January 30, 2025
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that James E. Galvin, MD, MPH will present topline results from the ‘SHIMMER' study of zervimesine (CT1812) in dementia with Lewy bodies during an oral presentation at the International Lewy Body Dementia Conference (ILBDC).
AI Summary
Cognition Therapeutics has announced that Dr. James E. Galvin, MD, MPH, will present the topline results from the SHIMMER study at the International Lewy Body Dementia Conference (ILBDC) in Amsterdam on January 31, 2025. Dr. Galvin, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, served as both the study director and principal investigator for this Phase 2 clinical trial, which evaluated zervimesine (CT1812) in patients with mild-to-moderate dementia with Lewy bodies (DLB).
The SHIMMER study, which enrolled 130 adults, compared zervimesine treatment to a placebo over six months. The results indicated that patients treated with zervimesine showed significant improvements across behavioral, cognitive, functional, and motor measures, suggesting it may be a promising therapeutic option for managing DLB.
Read Announcement- Drug:
- CT1812
- Announced Date:
- December 18, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced topline results from the exploratory Phase 2 ‘SHIMMER' study demonstrating CT1812 produced strong therapeutic responses across behavioral, functional, cognitive, and movement measures in patients with dementia with Lewy bodies (DLB).
AI Summary
Cognition Therapeutics announced promising topline results from their exploratory Phase 2 ‘SHIMMER’ study, showing that CT1812 produced strong therapeutic responses in patients with dementia with Lewy bodies (DLB). In this study of 130 patients with mild-to-moderate DLB, those treated with CT1812 for six months experienced significant improvements across behavioral, functional, cognitive, and movement measures compared to placebo. The findings include an 82% slowing in neuropsychiatric symptoms, with notable reductions in anxiety, hallucinations, and delusions. The study also showed a marked reduction in caregiver distress and a slowing of cognitive decline, including a 91% reduction in attention fluctuations. These positive outcomes support the further development of CT1812 and have expedited plans to advance the drug into late-stage clinical trials, with more detailed data to be presented at an upcoming international conference.
Read Announcement- Drug:
- CT1812
- Announced Date:
- November 26, 2024
- Target Action Date:
- December 1, 2024
- Estimated Target Date Range:
- December 1, 2024 - December 31, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics Topline results in second dementia indication expected to be reported in December 2024 –
AI Summary
Cognition Therapeutics, Inc. has announced an important milestone in its Phase 2 SHIMMER study evaluating CT1812 in patients with mild-to-moderate dementia with Lewy bodies. The study recently reached its completion as the final patient finished their last clinic visit. The company expects to report the topline results by December 2024, marking its second dementia indication announcement. This result will help determine the tolerability of CT1812 and provide insights into its potential benefits in improving cognitive function and overall performance in patients. The study involved careful assessments and extensive collaboration with experts and organizations committed to raising awareness of Lewy Body Dementia. The forthcoming data will contribute to a better understanding of CT1812, which is designed to address significant challenges in treating neurodegenerative disorders.
Read Announcement- Drug:
- CT1812
- Announced Date:
- November 26, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that the last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with Lewy bodies (DLB).
AI Summary
Cognition Therapeutics announced that the final patient in its Phase 2 SHIMMER study of CT1812 for mild-to-moderate dementia with Lewy bodies has completed their last clinic visit. The study, which enrolled 130 adults, is assessing how the experimental drug affects cognitive and motor functions over a six‐month period. Topline results from this trial are expected in December 2024, and the data will help determine CT1812’s tolerability and potential efficacy in improving cognition and everyday functioning.
The company expressed its gratitude to the patients, caregivers, and study investigators, including partners such as the National Institute on Aging and the Lewy Body Dementia Association. This research is important as it explores new therapeutic options for dementia with Lewy bodies, a condition affecting over a million Americans and urgently in need of effective treatments.
Read Announcement- Drug:
- CT1812
- Announced Date:
- August 22, 2024
- Indication:
- Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Announcement
Cognition Therapeutics, announced that results from the SEQUEL study of CT1812, the Company's lead candidate for the treatment of Alzheimer's disease, were published in The Journal of Prevention of Alzheimer's Disease.
AI Summary
Cognition Therapeutics announced that the results of its SEQUEL study have been published in The Journal of Prevention of Alzheimer’s Disease. The study explored the effects of CT1812— the company's lead candidate for treating Alzheimer’s disease—by tracking changes in brain wave patterns among 16 adults with mild-to-moderate Alzheimer’s over 29 days. Participants who received CT1812 showed consistent trends of improvement across several electroencephalography (EEG) measures. Notably, there were statistically significant improvements in the central region’s relative theta power and brain connectivity markers. These findings suggest that CT1812 may help normalize brain wave patterns and facilitate better communication between different brain regions by protecting synapses. The study supports the potential of CT1812 as a unique neuroprotective treatment for Alzheimer’s disease while demonstrating a favorable safety profile with only mild to moderate side effects reported.
Read Announcement
Cognition Therapeutics FDA Events - Frequently Asked Questions
As of now, Cognition Therapeutics (CGTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Cognition Therapeutics (CGTX) has reported FDA regulatory activity for CT1812.
The most recent FDA-related event for Cognition Therapeutics occurred on May 21, 2026, involving CT1812. The update was categorized as "Provided Update," with the company reporting: "Cognition Therapeutics, conducted a planned meeting with the U.S. Food and Drug Administration (FDA) on May 20, 2026. The objective of this meeting was to review results from the Phase 2 study of zervimesine (CT1812) and discuss the design and endpoints of a registrational study in dementia with Lewy bodies (DLB) patients with psychosis."
Currently, Cognition Therapeutics has one therapy (CT1812) targeting the following condition: Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:CGTX last updated on 5/21/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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