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    Home > Medical News > Medical World News > Another new Alzheimer's drug Phase 3 clinical start.

    Another new Alzheimer's drug Phase 3 clinical start.

    • Last Update: 2020-07-21
    • Source: Internet
    • Author: User
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    Turn fromOn July 13, the Alzheimer's Clinical Trials Alliance (ACTC), Eisai and Biogen announced that BAN2401, an anti-beta amyloid antibody, was used clinically normal, but that the brain had a moderate or higher level of preclinical (asymptomatic) Preclinical (asymptomatic) Individual Alzheimer's disease (pre-clinical) 35 (35th) clinical researchAHEAD 3-45 will be conducted in the United States, Japan, Canada, Australia, Singapore and EuropeBAN2401 is a human-derived anti-beta-amyloid protein (A-beta) proto-fibrosisit can be selectively combined with soluble Protofibrilsthese protofibers are fibrous complexes formed by the accumulation of Beta proteins, which are the intermediate stages of amyloid deposits from soluble monomersthere was no shortage of dramatic reversals in the development of new drugsBAN2401: BAN2401 showed no significant efficacy at 12 months of Phase 2 clinical trialsHowever, at the 18-month node, data analysis showed that BAN2401 not only reduced A-beta deposition in the patient's brain, but also improved cognitive decline in patients, which launched Phase 3 clinical trials (Clarity AD) in March last year, is expected to recruit 1,566 patients with early AD and receive BAN2401 at a dose of 10 mg/kgAHEAD 3-45 is a clinical Phase 3 study conducted in collaboration with the ACTC and TheGuardian, funded by the National Institutes of Aging (NIA) of the National Institutes of Health (NIH)in AHEAD 3-45, after a regular screening period, participants will be included in one of two randomized, double-blind, placebo-controlled trials based on amyloid levels in the brain: the A45 trial and the A3 trial1,400 subjects were enrolled in the study and were treated with BAN2401 for 216 weeksA45 trial will recruit undamaged participants with elevated levels of amyloid in the brain, aiming to prevent cognitive decline and inhibit the pathological progression of AD in the brain through the administration of BAN2401The primary endpoint ofA45 was the change of baseline of preclinical cognitive function complex endpoint 5 (PACC5) after 216 weeks of treatmentsecondary endpoint is a baseline change in brain amyloid levels measured by amyloid positron positron emission tomography (PET) and changes in brain tau protein levels measured by tau-PET and cognitive function index A3 trial spent the brain with moderate amounts of amyloid protein and no cognitive impairment of the risk of further A-beta accumulation The main endpoint of A3 is the change in brain amyloid protein levels measured by amyloid protein PET secondary endpoint is a change in the brain tau level measured by tau PET than the baseline both trials included additional clinical assessment scales, imaging tests, blood biomarkers, and cerebrospinal fluid (CSF) as exploratory endpoints imaging and biofluidsing (especially cerebrospinal fluid CSF) of the ATN (amyloid, Tau protein, neurodegenerative lesions) biomarker group, including A beta 1-42, A-beta 1-40, t-Tau, p-Tau, neuroparticle protein, and nerve wire light chain, will be used to evaluate the therapeutic effect semostive lysonation of AD "We hope that starting treatment earlier in the course of the disease may help prevent future cognitive decline," AHEAD3-45 should provide vital answers to the optimal intervention time for anti-amyloid therapy," said Dr Reisa Sperling, director of the Alzheimer's Disease Research and Treatment Center at Brigham and Women's Hospital and co-lead researcher at ACTC "The MISSION of the ACTC includes developing public-private partnerships and conducting promising trials of candidate therapies," said Dr Aisen, director of the Alzheimer's Treatment Institute at the University of Southern California, the ACTC Focal Point AHEAD 3-45 is the type of collaboration we need to work with in the fight against Alzheimer's disease "The launch of the AHEAD 3-45 clinical trial of AD in the early stages of BAN2401 treatment is an exciting time for us through partnership with ACTC," said Dr Lynn Kramer, Chief Clinical Officer and Chief Medical Officer, Of tison Neurology this represents the next step in developing AD precision therapy using biomarker groups as part of our mission to human health care, and we are committed to making a difference for patients, their families, and healthcare professionals around the world "Note: This article is intended to introduce the progress of medical health research, not the recommended treatment plan if you need guidance on a treatment plan, go to a regular hospital References: 1 Retrieved 2020-07-14, from the attention of the "drug mingcon" WeChat public number.
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