{"id":46167,"date":"2022-07-14T13:02:11","date_gmt":"2022-07-14T11:02:11","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/the-journal-lupus-publishes-investigator-initiated-study-results-demonstrating-improved-executive-function-in-patients-with-systemic-lupus-erythematosus-following-use-of-akilis-akl-t01-produc\/"},"modified":"2022-07-14T13:02:11","modified_gmt":"2022-07-14T11:02:11","slug":"the-journal-lupus-publishes-investigator-initiated-study-results-demonstrating-improved-executive-function-in-patients-with-systemic-lupus-erythematosus-following-use-of-akilis-akl-t01-produc","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/the-journal-lupus-publishes-investigator-initiated-study-results-demonstrating-improved-executive-function-in-patients-with-systemic-lupus-erythematosus-following-use-of-akilis-akl-t01-produc\/","title":{"rendered":"The Journal Lupus Publishes Investigator-Initiated Study Results Demonstrating Improved Executive Function in Patients with Systemic Lupus Erythematosus Following Use of Akili\u2019s AKL-T01 Product Candidate"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<i>Data show correlation between targeted activity in the brain and improvement in motor speed and executive function, providing further validation of Akili\u2019s technology platform and its potential to improve select cognitive impairments across different indications<\/i>\n<\/p>\n<p class=\"bwalignc\">\n<i>Data also offer preliminary evidence of EVO\u2122 Monitor\u2019s ability to provide rapid mobile assessment of cognitive function<\/i>\n<\/p>\n<p>BOSTON&#8211;(BUSINESS WIRE)&#8211;Akili Interactive Labs, Inc. (\u201cAkili\u201d), a leading digital medicine company, today announced the publication of full data from a randomized, unblinded study conducted by National Jewish Health and the University of Colorado School of Medicine Departments of Neurology, Psychiatry and Rheumatology that evaluated the ability of Akili\u2019s digital therapeutic AKL-T01 to improve cognitive dysfunction in patients diagnosed with Systemic Lupus Erythematosus (SLE). Data from the study show that AKL-T01 resulted in significant improvement in motor speed and executive functions. The study results were published in the medical journal <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fjournals.sagepub.com%2Fdoi%2F10.1177%2F09612033221098534&amp;esheet=52780691&amp;newsitemid=20220714005263&amp;lan=en-US&amp;anchor=Lupus&amp;index=1&amp;md5=dcd9a7fab13c4a9ffba081b84bfcab44\" rel=\"nofollow noopener\" shape=\"rect\"><i>Lupus<\/i><\/a>.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220714005263\/en\/689868\/5\/Akili_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220714005263\/en\/689868\/21\/Akili_Logo.jpg\"><\/a><\/p>\n<p>\nApproximately 1.5 million people in the United States are living with SLE.<sup>1<\/sup> Cognitive dysfunction occurs in 20% to 80% of patients with SLE<sup>2<\/sup>, twice the prevalence of the general population<sup>3<\/sup>, and substantially impacts their quality of life<sup>4<\/sup>.\n<\/p>\n<p>\nIn the randomized, unblinded study of 60 SLE patients aged 18-65, participants showed a high adherence to the 4-week AKL-T01 treatment and showed significant improvement in visuomotor speed (Trail Making A, p=0.025) and cognitive flexibility\/sequencing (Trail Making B, p=0.018) compared to the no contact control group. Further, the study investigated the ability of the product EVO<sup>TM<\/sup> Monitor<sup>5<\/sup>, built on the same technology platform, to serve as a rapid mobile assessment of cognitive function.\n<\/p>\n<p>\nAt baseline, the multitasking threshold (reaction time difference between single tasking and multitasking) from EVO<sup>TM<\/sup> Monitor was associated with performance on tasks of cognitive flexibility and psychomotor speed (Trail Making B, r=-0.37, p=0.001 and WAIS-IV coding, r=0.30, p=0.02). At follow up, the treatment group also demonstrated significant improvement in EVO<sup>TM<\/sup> Monitor compared to the control group (p=0.001). No additional between groups differences were found in other neuropsychological, behavioral, or health outcomes.\n<\/p>\n<p>\n\u201cCognitive difficulties such as attention and executive function are linked to a number of autoimmune diseases, yet there are limited assessments and few interventions to support them,\u201d said Anil S. Jina M.D., Chief Medical Officer of Akili. \u201cThe results of this study in patients with SLE are consistent with the cognitive improvements seen in other studies after using our digital therapeutic. We are excited to see this continued validation of our technology platform as we advance our pipeline to deliver clinically meaningful cognitive and quality-of-life improvements across patient populations.\u201d\n<\/p>\n<p>\nAKL-T01 is delivered through an action video game experience. The technology presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalize the treatment experience for each individual patient.\n<\/p>\n<p>\nAKL-T01 is built on Akili\u2019s Selective Stimulus Management Engine (SSME\u2122), its most advanced proprietary therapeutic engine, designed to target cognitive impairment at its source in the brain.\n<\/p>\n<p>\nSSME has been clinically validated across more than 20 research, proof-of-concept and pivotal clinical studies in a number of different disease areas to validate the efficacy and safety of Akili\u2019s digital therapeutic solutions for the treatment of cognitive impairments, including ADHD, multiple sclerosis (MS), and Autism Spectrum Disorder (ASD).\n<\/p>\n<p>\n<b>Study Design<\/b>\n<\/p>\n<p>\nThis was a randomized, unblinded study of 60 SLE patients aged 18-65. Study participants completed baseline neuropsychological tests (of attention, psychomotor speed, and executive function), a tablet-based digital assessment (EVO<sup>TM<\/sup> Monitor), and biobehavioral measures. The patients were randomized into treatment SLE (n=30) or no contact control SLE (n=30) groups, and returned four weeks later for follow-up cognitive, EVO<sup>TM<\/sup> Monitor, and biobehavioral testing. The SLE treatment group was trained on a tablet-based digital treatment (AKL-T01) and were instructed to complete 5 sessions at least 5 days per week for 4 weeks for a total of approximately 25 minutes of gameplay per day.\n<\/p>\n<p>\n<b>About Akili<\/b>\n<\/p>\n<p>\nAkili is pioneering the development of cognitive treatments through game-changing technologies. Our approach of leveraging technologies designed to directly target the brain establishes a new category of medicine \u2013 medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment. Akili\u2019s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili\u2019s belief that effective medicine can also be fun and engaging, Akili\u2019s products are delivered through captivating action video game experiences. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.akiliinteractive.com&amp;esheet=52780691&amp;newsitemid=20220714005263&amp;lan=en-US&amp;anchor=www.akiliinteractive.com&amp;index=2&amp;md5=399552756a3f34ecaafd6c715d52d61d\" rel=\"nofollow noopener\" shape=\"rect\">www.akiliinteractive.com<\/a>.\n<\/p>\n<p>\n<b>Forward-Looking Statements<\/b>\n<\/p>\n<p>\nThis communication may contain certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements generally are identified by the words \u201cbelieve,\u201d \u201cproject,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cstrategy,\u201d \u201cfuture,\u201d \u201copportunity,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cwill be,\u201d \u201cwill continue,\u201d \u201cwill likely result,\u201d and similar expressions and include statements regarding Akili\u2019s expectations for EndeavorRx\u00ae and digital medicine and the benefits expected therefrom. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Akili to successfully commercialize EndeavorRx\u00ae and continue to advance its clinical development pipeline, (ii) the ability of Akili to maintain relationships with customers and suppliers and retain its management and key employees, (iii) the evolution of the markets in which Akili competes, (iv) the ability of Akili to defend its intellectual property and satisfy regulatory requirements, (v) the impact of the COVID-19 pandemic on Akili\u2019s business, (vi) Akili\u2019s expectations regarding its market opportunities and (vii) the risk of downturns and a changing regulatory landscape in the highly competitive industry in which Akili operates. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Akili assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Akili does not give any assurance that it will achieve its expectations.\n<\/p>\n<p>\n<sup>1<\/sup><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.lupus.org%2Fresources%2Flupus-facts-and-statistics&amp;esheet=52780691&amp;newsitemid=20220714005263&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.lupus.org%2Fresources%2Flupus-facts-and-statistics&amp;index=3&amp;md5=6bcefc41996ea14bb9fa71494dcff9da\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.lupus.org\/resources\/lupus-facts-and-statistics<\/a>.\n<\/p>\n<p>\n<sup>2<\/sup>Hanly, JG, Harrison, MJ. Management of neuropsychiatric lupus. Best Pract Res Cl Rh 2005; 19: 799\u2013821.\n<\/p>\n<p>\n<sup>3<\/sup>Ainiala, H, Loukkola, J, Peltola, J. The prevalence of neuropsychiatric syndromes in systemic lupus erythematosus. Neurology 2001; 57: 496\u2013500.\n<\/p>\n<p>\n<sup>4<\/sup>Mendelsohn, S, Khoja, L, Alfred, S et al. Cognitive impairment in systemic lupus erythematosus is negatively related to social role participation and quality of life: a systematic review. Lupus 2021, 30:1617-1630.\n<\/p>\n<p>\n<sup>5<\/sup>EVO\u2122 Monitor incorporates a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern video game graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user&#8217;s ability.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media<br \/>\n<br \/><\/b><b>Akili<br \/>\n<br \/><\/b>Julie DiCarlo<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;&#108;t&#x6f;&#x3a;&#x6a;&#117;&#108;i&#x65;&#x40;&#x61;&#107;&#105;l&#x69;&#x69;&#x6e;&#116;&#101;r&#x61;&#x63;&#x74;&#105;ve&#x2e;&#x63;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6a;&#x75;&#108;ie&#x40;&#x61;&#107;&#105;l&#x69;&#x69;&#110;&#116;e&#x72;&#x61;&#x63;&#116;iv&#x65;&#x2e;&#99;&#111;m<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Data show correlation between targeted activity in the brain and improvement in motor speed and executive function, providing further validation of Akili\u2019s technology platform and its potential to improve select cognitive impairments across different indications Data also offer preliminary evidence of EVO\u2122 Monitor\u2019s ability to provide rapid mobile assessment of cognitive function BOSTON&#8211;(BUSINESS WIRE)&#8211;Akili Interactive &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/the-journal-lupus-publishes-investigator-initiated-study-results-demonstrating-improved-executive-function-in-patients-with-systemic-lupus-erythematosus-following-use-of-akilis-akl-t01-produc\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-46167","format-standard","category-industry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The Journal Lupus Publishes Investigator-Initiated Study Results Demonstrating Improved Executive Function in Patients with Systemic Lupus Erythematosus Following Use of Akili\u2019s AKL-T01 Product Candidate - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/the-journal-lupus-publishes-investigator-initiated-study-results-demonstrating-improved-executive-function-in-patients-with-systemic-lupus-erythematosus-following-use-of-akilis-akl-t01-produc\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Journal Lupus Publishes Investigator-Initiated Study Results Demonstrating Improved Executive Function in Patients with Systemic Lupus Erythematosus Following Use of Akili\u2019s AKL-T01 Product Candidate - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Data show correlation between targeted activity in the brain and improvement in motor speed and executive function, providing further validation of Akili\u2019s technology platform and its potential to improve select cognitive impairments across different indications Data also offer preliminary evidence of EVO\u2122 Monitor\u2019s ability to provide rapid mobile assessment of cognitive function BOSTON&#8211;(BUSINESS WIRE)&#8211;Akili Interactive ... 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