{"id":12734,"date":"2024-06-04T15:26:13","date_gmt":"2024-06-04T15:26:13","guid":{"rendered":"https:\/\/cogrx.com\/?page_id=12734"},"modified":"2026-01-30T15:46:08","modified_gmt":"2026-01-30T20:46:08","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/cogrx.com\/clinical-trials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"\t\t
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Clinical Trials in Neurodegenerative Diseases<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\tWe are currently conducting clinical studies of our lead candidate, zervimesine (also CT1812), in several indications described below. Zervimesine is an experimental candidate and has not been approved by the U.S. FDA or other regulatory agency. \u200b\u200bIf you have questions about any of the studies you see listed, please consult with your physician.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Active, not Recruiting:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"START\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Phase 2 START study has met its recruitment target. There are currently 540 individuals (50 to 85 years of age) enrolled from US sites who have MCI or early-stage Alzheimer\u2019s disease. Participants are randomized to receive either a placebo or the experimental candidate, zervimesine (CT1812). Patients on a stable background of approved immunotherapies may be eligible. The START study is being conducted in collaboration with the Alzheimer\u2019s Clinical Trials Consortium (ACTC). More information may be found on clinicaltrials.gov under trial identifier NCT05531656<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Active, Not Recruiting:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\tThe Phase 2 MAGNIFY study was designed to recruit individuals (\u2265 50 years of age) who have a diagnosis of dry age-related macular degeneration with measurable geographic atrophy. Up to 246 participants were to be randomized to receive either placebo or the experimental candidate, zervimesine for 24 months. More information may be found on clinicaltrials.gov under trial identifier NCT05893537<\/a>.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Completed Studies:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"SHIMMER\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Phase 2 COG1201 ‘SHIMMER’ study enrolled 130 patients with mild-to-moderate dementia with Lewy bodies (DLB). Participants were randomized to receive one of two doses of the experimental candidate, zervimesine, or placebo for six months. More information about SHIMMER can be found on clinicaltrials.gov under trial identifier NCT04735536<\/a>.<\/p>

On December 18, 2024, Cognition conducted a webcast to review findings from the SHIMMER study. An archive of the call and supporting materials may be found here<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The Phase 2 SHINE study recruited 153 individuals (50 to 85 years of age) who have mild-to-moderate Alzheimer\u2019s disease. Participants were randomized to receive one of two doses of the experimental candidate, zervimesine, or placebo for six months. More information may be found on clinicaltrials.gov under trial identifier NCT03507790<\/a>.<\/p>

On July 29, 2024, Cognition held a conference call to review topline findings from the SHINE study. An archive of the call and supporting materials may be found here<\/a>. Cognition conducted a second call on October 30, 2024 to review findings of a pre-specified analysis of SHINE subgroups defined by their baseline plasma p-tau217 concentrations. An archive of this call and supporting materials may be found<\/span>\u00a0<\/span>here<\/a>.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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SEQUEL<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Phase 2 COG0202 ‘SEQUEL’ study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of 16 patients with mild-to-moderate AD to evaluate the potential efficacy of zervimesine in restoring synaptic function in patients through qEEG measurement, as reflected by relative theta power. More information about SEQUEL can be found on clinicaltrials.gov under trial identifier NCT04735536<\/a>.<\/p>

On June 28, 2023, Cognition held a conference call to review findings from the SEQUEL study. An archive of the call and supporting materials may be found here<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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SPARC<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\tThe Phase 1 COG0105 ‘SPARC’ study is a randomized, double-blind, placebo-controlled clinical trial of 23 patients with mild-to-moderate AD to evaluate zervimesine for safety and tolerability. Secondary objectives include the evaluation of potential effects of zervimesine on biologically relevant endpoints using various imaging modalities, including PET imaging and vMRI. More information about SPARC may be found on clinicaltrials.gov under trial identifier NCT03493282<\/a>.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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SNAP<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Phase 1 COG0104 ‘SNAP’ study was a randomized, double-blind, placebo-controlled clinical trial that enrolled three patients with mild-to-moderate AD to measure the effects of zervimesine on displacement of A\u03b2 oligomers. More information about SPARC may be found on clinicaltrials.gov under trial identifier NCT03522129<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Additional Resource for Patients and their Families<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Alzheimer's Disease<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Dementia with Lewy Bodies<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"lbrc-logo\"\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Geographic Atrophy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"prevent\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"BrightFocus\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Clinical Trial Terminology<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Before a novel product candidate can be approved, it must complete a rigorous clinical development process, which typically includes three distinct types of trials. Phase 1 clinical trials test experimental treatments at a variety of doses in healthy volunteers to understand how the candidate works in the human body and identify safety issues that may not have been apparent in preclinical research.<\/p>

Following successful completion of Phase 1 trials, experimental therapies often advance into one or more Phase 2 trials to evaluate the efficacy and safety of a candidate in the target patient population. Goals for Phase 2 trials may include selecting an optimal dose or dosing regimen, identifying specific patient group who may respond to medication more or less favorably, and assessing the safety and tolerability profile. Meetings with the U.S. Food and Drug Administration and other countries\u2019 regulatory authorities are held following the conclusion of Phase 2 clinical trials to review data before proceeding into the next phase of development.<\/p>

Phase 3 trials are the final step in a product\u2019s clinical develop and are designed to test the optimal dose or dosing regimen in a large number of people with a specific disease or condition. They aim to enroll people with diversity in race, gender, geography, and socioeconomic status to mirror the conditions in which a candidate might be used in the future when it\u2019s broadly available.<\/p>

Because these studies involve experimental treatments, all clinical trials are closely monitored by regulatory authorities as well as independent ethics committees (IECs) or institutional review boards (IRBs) to ensure that any safety issues that arise are carefully documented.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Expanded Access Policy<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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We are a clinical stage biopharmaceutical company engaged in the development of small-molecule therapeutics targeting age-related degenerative diseases. We currently have several clinical studies planned or underway that are designed to measure safety and efficacy outcomes of our experimental medication, zervimesine for patients with Alzheimer\u2019s disease and dementia with Lewy bodies.<\/p>\n

Due to the strong interest expressed by participants and families in our Phase 2 \u2018SHIMMER\u2019 study, we opened a limited Expanded Access Program (EAP) for people with DLB. Due to regulatory requirements, we are unable to extend this program to other indications.<\/p>\n

The DLB EAP, termed COG1202, enrolled people who participated in the SHIMMER study who meet specific eligibility criteria. The EAP was also open to additional adults with a diagnosis of mild-to-moderate DLB who met the criteria for this program and were able to travel to the participating study sites. Enrollment in the EAP concluded in December 2025.<\/p>\n

As an investigational drug, zervimesine has not been approved by regulatory authorities. Therefore, the safety and efficacy of zervimesine have not been fully characterized and there may be risks associated with its use. More information is available on <\/span>https:\/\/clinicatrials.gov<\/a> under study identifier, NCT06961760.<\/span><\/p>\n

At this time, we are not able to offer expanded access for other indications beyond DLB. Until zervimesine completes clinical development and is reviewed and approved by regulatory authorities, it can only be accessed through participation in our clinical trials. The START Study is currently enrolling people with early-stage Alzheimer\u2019s disease. More information may be found on https:\/\/clinicaltrials.gov<\/a> under trial identifier NCT05531656.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Clinical Trials in Neurodegenerative Diseases We are currently conducting clinical studies of our lead candidate, zervimesine (also CT1812), in several indications described below. Zervimesine is an experimental candidate and has not been approved by the U.S. FDA or other regulatory agency. \u200b\u200bIf you have questions about any of the studies you see listed, please consult […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_theme","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-12734","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/cogrx.com\/wp-json\/wp\/v2\/pages\/12734","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cogrx.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cogrx.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cogrx.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cogrx.com\/wp-json\/wp\/v2\/comments?post=12734"}],"version-history":[{"count":0,"href":"https:\/\/cogrx.com\/wp-json\/wp\/v2\/pages\/12734\/revisions"}],"wp:attachment":[{"href":"https:\/\/cogrx.com\/wp-json\/wp\/v2\/media?parent=12734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}