{"id":2178,"date":"2026-08-03T12:00:25","date_gmt":"2026-08-03T12:00:25","guid":{"rendered":"https:\/\/askneurology.com\/index.php\/2026\/08\/03\/fda-designation-may-speed-new-treatment-for-alzheimers-psychosis\/"},"modified":"2026-08-03T12:00:25","modified_gmt":"2026-08-03T12:00:25","slug":"fda-designation-may-speed-new-treatment-for-alzheimers-psychosis","status":"publish","type":"post","link":"https:\/\/askneurology.com\/index.php\/2026\/08\/03\/fda-designation-may-speed-new-treatment-for-alzheimers-psychosis\/","title":{"rendered":"FDA designation may speed new treatment for Alzheimer\u2019s psychosis"},"content":{"rendered":"

\"A<\/a><\/p>\n

The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals<\/a> is developing for hallucinations and delusions associated with Alzheimer\u2019s disease<\/a> psychosis.<\/p>\n

The FDA grants this designation to investigational medicines intended to treat serious conditions and fill an unmet medical need. Fast track status provides benefits such as more frequent communication with the FDA, with the goal of speeding a therapy\u2019s development and review.<\/p>\n

\u201cFDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer\u2019s disease psychosis, a serious condition for which there are currently no FDA-approved therapies. This is an important milestone for the remlifanserin program,\u201d Catherine Owen Adams, CEO of Acadia, said in a company press release<\/a>.<\/p>\n

\n Recommended Reading<\/span>\n
\n
\n \"A\n <\/div>\n
\n
\n May 4, 2026<\/span>
\n\t\t News<\/a><\/span>
\n\t\t by Marisa Horak, MS<\/a><\/span>\n <\/div>\n

<\/a><\/p>\n

FDA approves Auvelity to treat Alzheimer\u2019s-related agitation<\/h3>\n

\n <\/p><\/div>\n<\/div>\n<\/div>\n

Understanding Alzheimer\u2019s psychosis<\/h3>\n

Psychosis can involve hallucinations, such as seeing or hearing things that aren\u2019t there, and delusions, which are fixed beliefs not based in reality. Psychosis is thought to involve imbalances in brain signaling that can cause certain nerve cells to become overly active. Altered serotonin signaling has also been linked to psychosis.<\/p>\n

Remlifanserin is designed to reduce signaling through the serotonin 5-HT2A receptor, a brain protein involved in serotonin signaling. Acadia believes this may help restore the balance between excitatory and inhibitory brain signaling, potentially reducing hallucinations and delusions. The company is developing remlifanserin for psychosis associated with Alzheimer\u2019s disease and Lewy body disease.<\/p>\n

Acadia is currently conducting the Phase 2\/3 RADIANT clinical trial program (NCT06159673)<\/a> to test remlifanserin in people with Alzheimer\u2019s disease psychosis. The Phase 2 study tested two doses, 30 and 60 mg, against a placebo, with the main goal of assessing their effects on a standardized measure of psychosis severity after six weeks. Based on those results, both doses or a selected dose will be evaluated against placebo in two independent Phase 3 studies.<\/p>\n

Enrollment in the Phase 2 study is complete, and Acadia expects to announce topline results in September or October 2026. The two Phase 3 studies are already screening and enrolling adults ages 55 to 95 with Alzheimer\u2019s disease psychosis at sites internationally<\/a>.<\/p>\n

\u201cThis is an important milestone for the remlifanserin program, and we look forward to sharing upcoming topline data from the RADIANT Phase 2 trial as we continue to advance remlifanserin as a potential new treatment option for patients and families impacted by this devastating condition,\u201d Adams said.<\/p>\n

<\/p>\n

The post FDA designation may speed new treatment for Alzheimer\u2019s psychosis<\/a> appeared first on Alzheimer’s News Today<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals […]<\/p>\n","protected":false},"author":2,"featured_media":2179,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","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":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-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":"","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-4)","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-4)","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-4)","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":""},"categories":[25],"tags":[],"class_list":["post-2178","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-alzheimer"],"_links":{"self":[{"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/posts\/2178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/comments?post=2178"}],"version-history":[{"count":0,"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/posts\/2178\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/media\/2179"}],"wp:attachment":[{"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/media?parent=2178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/categories?post=2178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/askneurology.com\/index.php\/wp-json\/wp\/v2\/tags?post=2178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}