Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of Patients With With Mild Cognitive Impairment (MCI) or Mild Alzheimer's Disease (AD) Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

The purpose of this study is to assess the safety and feasibility of administering standard of care monoclonal antibody (mAb) infusion therapy in combination with opening the blood-brain barrier with the Exablate Model 4000 Type 2 device in patients with mild Alzheimer's disease (AD) or mild cognitive impairment (MCI).

Start Date14 Jul 2022

Sponsor / Collaborator

West Virginia University

[+1]

NCT05310071 / TerminatedPhase 3

A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

Start Date02 Jun 2022

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Aducanumab-avwa

100 Translational Medicine associated with Aducanumab-avwa

100 Patents (Medical) associated with Aducanumab-avwa

585

Literatures (Medical) associated with Aducanumab-avwa

01 Jan 2025·NUCLEAR MEDICINE AND BIOLOGY

New prospects for 89Zr-immuno-PET in brain applications – Alpha-synucleinopathies

Article

Author: Bang-Andersen, Benny ; Bjerregaard-Andersen, Kaare ; Sotty, Florence ; Windhorst, Albert D ; Wuensche, Thomas E ; van Dongen, Guus A M S ; Vugts, Danielle J ; Pereira, Pedro M ; Kallunki, Pekka ; Jensen, Allan ; Beaino, Wissam

BACKGROUND:

Recently, ⁸⁹Zr-immuno-PET imaging of therapeutic antibodies, actively transported over the blood-brain-barrier via transferrin-mediated transcytosis, was demonstrated using the chelator DFO*. In these studies, aducanumab targeting amyloid-beta was fused with a transferrin binding unit: a single-chain Fab fragment derived from 8D3 (scFab8D3). Alpha-synuclein is a hallmark protein of several neurodegenerative diseases such as Parkinson's Disease, Lewy-Body-Dementia, and Multiple System Atrophy. ⁸⁹Zr-immuno-PET imaging of alpha-synuclein can be a valuable tool for image-guided drug development and assessment of target engagement. The goal of this study was to compare two currently used constructs of 8D3 for targeting potential, namely a single moiety of scFab8D3 fused to the alpha-synuclein antibody HLu-3 (HLu-3-scFab8D3) versus HLu-3 fused with two 8D3 single-chain variable fragments (HLu-3-(scFv8D3)₂), by ⁸⁹Zr-immuno-PET in an alpha-synuclein pre-formed fibril (PFF) deposition model. HLu-3 and the HIV-targeting B12-scFab8D3 were used as controls. The best-performing compound was further investigated in an animal model with predominantly intraneural target aggregation.

METHODS:

Antibodies were conjugated with DFO* using DFO*-NCS and subsequently radiolabeled with ⁸⁹Zr. Assessment of binding affinity was done by alpha-synuclein ELISA and with FACS analysis using mTfR1 expressing CHO-S cells. Radioimmunoconjugates were first evaluated in an extracellular alpha-synuclein deposition model established by intracranial injection of non-sonicated PFFs into the left striatum of C57Bl/6 WT mice, whereas saline was injected into the contralateral site as control. PET imaging was performed 1, 3, and 7 days post-injection, followed by ex vivo biodistribution, autoradiography and immunofluorescence analysis. Based on the results from these studies, the better-performing antibody candidate was tested similarly in an alpha-synuclein seeding model. The seeding model has intraneural alpha-synuclein aggregation and was established by intracranial injection of sonicated PFFs into both striata of F28tg mice, which overexpress human wild-type alpha-synuclein. Untreated F28tg and C57Bl/6 WT mice served as controls.

RESULTS:

The radioimmunoconjugate was produced in sufficient radiochemical yields and purity. There was no impairment of binding affinity towards alpha-synuclein, and acceptable binding with negligible losses to mTfR1. PET imaging with [⁸⁹Zr]Zr-HLu-3-scFab8D3 and [⁸⁹Zr]Zr-HLu-3-(scFv8D3)₂ in the deposition model showed uptake at the site of alpha-synuclein deposits. However, uptake was variable between mice. Reliable PET quantification was hampered due to the small deposition volume (~2 μL). Immunofluorescence revealed specific alpha-synuclein target engagement of both constructs with PFF deposits in the striatum, in contrast to the [⁸⁹Zr]Zr-B12-scFab8D3 control. Unexpectedly, ex vivo autoradiography showed uptake in some controls ([⁸⁹Zr]Zr-B12-scFab8D3 in the contralateral striatum without PFFs), potentially related to astrocyte activation at the injection sites. Ex vivo and PET brain uptake was higher for [⁸⁹Zr]Zr-HLu-3-scFab8D3 when compared to [⁸⁹Zr]Zr-HLu-3-(scFv8D3)₂ and was therefore selected for further testing in the alpha-synuclein seeding model. No significant difference in in vivo and ex vivo brain uptake of [⁸⁹Zr]Zr-HLu-3-scFab8D3 between PFF-injected F28tg, F28tg and C57Bl/6 mice was observed. Furthermore, ex vivo immunofluorescence and autoradiography showed no specific alpha-synuclein target engagement.

CONCLUSIONS:

Successful target engagement of [⁸⁹Zr]Zr-HLu-3-scFab8D3 and [⁸⁹Zr]Zr-HLu-3-(scFv8D3)₂ with alpha-synuclein was shown in a PFF deposition model. PET imaging showed variable results, and in vivo detection of the depositions was possible in some cases. Due to the better performance in the deposition model, [⁸⁹Zr]Zr-HLu-3-scFab8D3 was further investigated in an alpha-synuclein seeding model with intraneural Lewy-body pathology, showing no difference between the control groups and PFF-seeded mice. Furthermore, immunostaining of seeded F28tg mice manifested sufficient intraneural alpha-synuclein pathology but no corresponding antibody accumulation. These results underscore the ongoing challenge of imaging intraneural inclusions via immuno-PET.

01 Jan 2025·AGEING RESEARCH REVIEWS

Disease-modifying therapies for Alzheimer’s disease: Clinical trial progress and opportunity

Review

Author: Zhang, Yujie ; Luo, Shilin ; Jiao, Bin ; Chen, Jie ; Li, Yanru

The U.S. Food and Drug Administration (FDA) recently approved lecanemab and donanemab for the treatment of early symptomatic Alzheimer's disease (AD) after their phase III trials reached endpoints. These two anti-amyloid β monoclonal antibodies represent the latest promise of disease-modifying therapy (DMT) for AD, which undoubtedly reignites new hope for DMTs to combat the staggering financial and human costs of AD. However, in addition to these two successful antibodies, there have been enormous efforts to develop DMTs in various aspects to meet the therapeutic requirement of AD. In this review, we delineate the core principles and methodologies of diverse DMTs, covering the advances in clinical trials of drug candidates that either have been discontinued, completed, or are ongoing, as well as brain stimulation and lifestyle interventions. In addition, by overseeing the fate of various candidate molecules, we hope to provide references and ideas for prospective approaches and promising applications of DTMs for AD, particularly in terms of universality and clinical application economics, to optimize efficacy and maximize AD patient benefits in the future.

01 Dec 2024·Neurology and Therapy

Passive Anti-amyloid Beta Monoclonal Antibodies: Lessons Learned over Past 20 Years

Review

Author: Decourt, Boris ; Wicker, Alexandra ; Sabbagh, Marwan Noel ; Shriram, Jahnavi

Alzheimer's disease (AD) is a neurodegenerative disorder that significantly impairs cognitive and functional abilities, placing a substantial burden on both patients and caregivers. Current symptomatic treatments fail to halt the progression of AD, highlighting the urgent need for more effective disease-modifying therapies (DMTs). DMTs under development are classified as either passive or active on the basis of their mechanisms of eliciting an immune response. While this review will touch on active immunotherapies, we primarily focus on anti-amyloid beta monoclonal antibodies (mAbs), a form of passive immunotherapy, discussing their multifaceted role in AD treatment and the critical factors influencing their therapeutic efficacy. With two mAbs now approved and prescribed in the clinical setting, it is crucial to reflect on the lessons learned from trials of earlier mAbs that have shaped their development and contributed to their current success. These insights can then guide the creation of even more effective mAbs, ultimately enhancing therapeutic outcomes for patients with AD while minimizing adverse events.

544

News (Medical) associated with Aducanumab-avwa

14 Nov 2024

·www.prnewswire.com

FDA authorizes the first AI-driven MRI solution for safer Alzheimer's treatment

BOSTON and LEUVEN, Belgium, Nov. 14, 2024 /PRNewswire/ -- Why this news will impact the lives of people affected by Alzheimer's disease: Continue Reading Figure 1: Example of how ARIA can present itself on a brain MRI scan Figure 2: Example reports of icobrain aria The first disease-modifying therapies for Alzheimer's disease have come to the market over the previous years – providing hope to the millions affected by Alzheimer's disease. These therapies have been linked to the development of specific brain abnormalities known as Amyloid-Related Imaging Abnormalities (ARIA), which, although rare, can lead to neurological complications. Regular brain MRI scans are needed to assess ARIA, but the detection and severity scoring is complex and time-consuming. The FDA authorizes icobrain aria as the first and only AI solution to detect, diagnose, and monitor ARIA for individuals with Alzheimer's disease On November 7th 2024, the U.S. Food and Drug Administration (FDA) granted icometrix clearance for icobrain aria, the first and only AI software approved for detecting, measuring and grading amyloid-related imaging abnormalities (ARIA), a potentially harmful side effect of new amyloid-targeting therapies. A large study, needed for FDA clearance, demonstrated that the use of icobrain aria significantly increases the accuracy of ARIA assessments by radiologists and hence allows for safer use of new amyloid-beta targeting therapies for Alzheimer's disease patients. The slow adoption of Alzheimer's treatments amid safety concerns The FDA's nod for icobrain aria comes at a time when much-needed new Alzheimer's treatments are reshaping care options in the United States. The first breakthrough in Alzheimer's disease treatment was in 2021 when aducanumab (Aduhelm) became the first FDA-approved drug intended to slow Alzheimer's progression by reducing amyloid plaques in the brain. This breakthrough, making headlines worldwide, was followed by other therapies, including lecanemab (Leqembi) and donanemab (Kisunla), each designed to target amyloid buildup, which is believed to play a role in Alzheimer's disease. Together, these treatments represent a shift from symptom management to disease-modifying approaches, offering hope to millions of patients and their families. However, these promising drugs also carry risks, one of which is the development of ARIA (amyloid-related imaging abnormalities), a complication that can cause lesions in the brain, including edema, swelling and/or hemorrhages. According to the FDA, the prescription of these amyloid-targeting therapies requires intensive ARIA monitoring with repeated magnetic resonance imaging (MRI) brain scans to detect and assess these changes before they pose serious neurological risks. Until now, identifying and evaluating ARIA has been a labor-intensive process, involving detailed, time-consuming, and visual comparisons of the brain MRI scans by radiologists. FDA nod for AI software to ensure patient safety ico brain aria is a unique deep-learning-based AI solution that was trained on thousands of brain MRI scans to accurately detect, diagnose, and monitor ARIA and its severity. The software works in the background and automatically generates an overview report on the ARIA assessment for radiologists using normal clinical MRI scans. Impacting care for people with Alzheimer's disease This FDA clearance is a big step forward in Alzheimer's care, demonstrating how technology can help bring safe and effective treatments to more people. With icobrain aria, physicians now have a powerful tool that helps them make informed treatment decisions, ensuring that patients receive the right care at the right time. This is a clear example of how advanced technology can make a difference in healthcare, supporting doctors and making important new therapies more widely accessible. About icometrix icometrix is a global leader in AI-driven software for brain imaging, transforming MRI and CT scans into actionable data for neurological conditions such as Alzheimer's, multiple sclerosis, and Parkinson's disease. Used in over 300 hospitals worldwide, icobrain technology is setting new standards in precision brain health, supporting doctors with tools that are FDA-cleared in the U.S. and approved in regions across the globe. With a commitment to advancing safe, effective treatments, icometrix partners with top pharmaceutical and health tech companies to bring innovative solutions to those who need them most. Media Contact: [email protected] or CEO and CTO Wim Van Hecke - CEO [email protected] +32 484 92 73 00 SOURCE icometrix WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

11 Nov 2024

·www.pharmaceutical-technology.com

Investment surges, hurdles and emerging innovations in neuroscience

FT Global Pharma and Biotech Summit 2024. Credit: Irena Maragkou Innovation in neuropsychiatry has been dormant for nearly forty years, said Kabir Nath, CEO, Compass Pathways in a panel discussion at the FT Global Pharma and Biotech Summit on 7 November. Recent developments, such as the approval of Bristol Myers Squibb’s Cobenfy (xanomeline-trospium) for the treatment of schizophrenia and Sage Therapeutics’ approval of Zurzuave (zuranolone) in post-partum depression signify a change in that. The significant lack of innovation is changing, with large Phase III studies investigating psychedelics such as psylocibin in an effort to “move from anecdotal experience to evidence” Nath stated. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. A major hurdle in the neuroscience field is that Phase III trials are costly and current animal models do not translate well for CNS disorders, which makes clinical research for neuropsychiatry and neurodegenerative diseases challenging. This makes the right patient selection strategy crucial. Targeting the right patient population While discussing if the pharmaceutical sector is going to see a return on investment (ROI) in this field, Seth Ettenburg, President and CEO, BlueRock Therapeutics, highlighted that investment in neuroscience is cyclical, with some excitement for emerging treatments. However, this is underlined by a lack of clear causality and biomarkers which makes cures more elusive compared to other fields. Bromley noted that approval of a product in this very complex field is challenging and the launch of Leqembi was a remarkable example of establishing proof of concept in neurodegenerative diseases. Introducing new treatments for conditions like Alzheimer’s Disease requires massive infrastructure, said Kylie Bromley, Vice President and Managing Director, UK & Ireland, Biogen. Biogen’s Aduhelm (aducanumab) was one of the first amyloid-targeting drugs to be approved for Alzheimer’s treatment wave, but it was pulled from the market earlier this year. Additionally, identifying the right patients is crucial, as only a small subset—around 2% of diagnosed Alzheimer’s patients—are suitable for current treatments, with early-stage patients showing the best response. Therefore, improving diagnosis will be key to tackling neurodegenerative disease and thus investment in less intrusive diagnosis methods, such as blood-based biomarkers will be crucial. Overall “infrastructure implementation will enable access to treatments” she concluded. According to the speakers, investment in neuroscience involves a high risk, cost and failure rate. While discussing the case of Leqembi, which saw less commercial success than analysts initially expected, Nath compared it to Johnson & Johnson’s Spravato, which took many years but is now becoming a blockbuster drug. Innovation in neurodegenerative diseases. The importance of biomarkers and technology (such as blood-based diagnostics, AI) offering new diagnostic tools, was highlighted by Bromley, who mentioned the software Novoic can use AI to identify patients earlier for clinical trials, streamlining the process. Technology is increasingly critical in early patient identification and trial recruitment, especially in identifying pre-symptomatic patients as research is looking earlier in the disease. According to her, AI and analytics advancements could improve diagnostic efficiency and foster a more targeted approach, crucial for treatments with narrow patient applicability. Is raising money in neuroscience becoming easier? In the case of neuropsychiatry, Nath stated that the space is a small community, but there is growing interest in the therapeutic potential of psychedelics for PTSD, depression, and anxiety, despite regulatory hurdles and mixed public perception. However, large-scale robust trials are essential, especially in a field that lacks robust biological markers, he added. The neuropsychiatry field faces persistent challenges due to the lack of biological biomarkers for conditions like depression, relying instead on broad diagnostic labels. According to Nath, a precision approach is not applicable in neuropsychiatry as companies fail to transition from Phase II to Phase III clinical trials, bringing up the example of Alto Neuroscience’s recent setback in a Phase IIb trial (NCT05712187). Nath believes that the potential for functional improvements and quality-of-life gains fuels optimism and investment. With one in nine people having a CNS disorder, there is an unmet need and untapped opportunity and Ettenbrugh said “opportunity in the space drives investment”. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Phase 2Phase 3Drug Approval

05 Nov 2024

·www.businesswire.com

Alzheimer's Drugs Global Market Overview 2024 - 9.9% CAGR Forecast During 2024-2030, with Market Set to Reach a Projected US$9.2 Billion by 2030 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Alzheimer's Drugs - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering. The global market for Alzheimer's Drugs is forecast to maintain a robust CAGR of 9.9% during the 2024-2030 analysis period, to reach a projected US$9.2 billion by 2030 from an estimated US$5.2 billion in 2024. The rising prevalence of Alzheimer's disease, driven mainly by the aging population, is leading to the expansion of the Alzheimer's drugs market. With the increase in life expectancy, especially in developed countries, there is a growing number of people at risk for Alzheimer's disease, leading to a larger group of potential patients. Innovations in drug development, such as medications aimed at the root cause of illnesses, combined with increased awareness and early diagnoses, further drive this market growth. Additionally, governments and healthcare organizations are boosting their financial support for Alzheimer's research, accelerating the development of new drugs, and expediting regulatory approvals. However, several factors hinder market growth, including the high cost and complexity of drug development, frequent clinical trial failures, patent expirations, limited awareness of Alzheimer's in underdeveloped countries, and the high cost of treatments, which restrict accessibility and market potential. Alzheimer's Drugs Regional Market Analysis North America leads the Alzheimer's drugs market with an estimated share of 38.9% in 2024, driven by a high prevalence of the disease, recent drug approvals, and advanced healthcare systems. The region benefits from major pharmaceutical companies conducting research and clinical trials alongside an aging population. Conversely, the Asia Pacific region is projected to be the fastest-growing market, with a CAGR of 11.5% during the analysis period 2024-2030. This growth is fueled by the rising prevalence of Alzheimer's, increased awareness, and a focus on unmet medical needs, particularly in countries like China and India. The region's less stringent regulations make it an attractive location for clinical trials and drug development. Alzheimer's Drugs Market Analysis by Drug Class Cholinesterase inhibitors dominate the Alzheimer's drugs market, holding an estimated 42.3% share in 2024, driven by their effectiveness in treating mild-to-moderate Alzheimer's through increased acetylcholine levels. Their oral administration and proven efficacy solidify their role as primary treatment. Conversely, the others segment, which includes monoclonal antibodies, anti-amyloid beta drugs, and pipeline drugs, is expected to register the fastest CAGR of 11.9% during the analysis period 2024-2030, fueled by rising regulatory approvals and the launch of disease-modifying therapies targeting Alzheimer's pathology. Alzheimer's Drugs Market Analysis by Route of Administration Oral drugs lead the market with an estimated share of 57% in 2024 due to their ease of administration and non-invasive nature, which enhances patient compliance. Oral medications, such as cholinesterase inhibitors, can be self-administered, providing convenience for patients, especially elderly individuals with multiple comorbidities. The injectable segment is projected to record the fastest growth, with a CAGR of 11.7% during the forecast period from 2024 to 2030, driven by monoclonal antibodies like Aducanumab and Leqembi, which offer potential disease-modifying effects for advanced Alzheimer's stages. Alzheimer's Drugs Market Analysis by Distribution Channel The hospital pharmacy segment dominates the market with an estimated 47.7% share in 2024, driven by increasing procurement of prescription drugs and its role in integrated care models. Hospital pharmacies coordinate multidisciplinary approaches that include pharmaceutical interventions, counseling, and community support, ensuring comprehensive care for Alzheimer's patients. Meanwhile, the online pharmacy segment is anticipated to grow significantly, with a CAGR of 12.7% during the analysis period 2024-2030. This growth is fueled by the rising number of Alzheimer's patients and the convenience of online purchasing, which is particularly beneficial for elderly people, and disabled individuals, supported by increased internet usage and digital service adoption. Alzheimer's Drugs Market Report Scope This global report on Alzheimer's Drugs analyzes the market based on drug class, route of administration and distribution channels. In addition to providing profiles of major companies operating in this space, the latest corporate and industrial developments have been covered to offer a clear panorama of how and where the market is progressing. Key Metrics Historical Period: 2021-2023 Base Year: 2023 Forecast Period: 2024-2030 Units: Value market in US$ Companies Mentioned: 10+ Key Attributes: Report Attribute Details No. of Pages 253 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $5.2 Billion Forecasted Market Value (USD) by 2030 $9.2 Billion Compound Annual Growth Rate 9.9% Regions Covered Global Key Topics Covered: PART A: GLOBAL MARKET PERSPECTIVE 1. INTRODUCTION Product Outline Alzheimer's Drugs Defined Alzheimer's Drug Classes Cholinesterase Inhibitors NMDA Receptor Antagonists Combination Drugs Others (Including Monoclonal Antibodies, Anti-amyloid Beta, Nutritional supplements, and Pipeline Drugs) Alzheimer's Drug Route of Administration Oral Injectable Transdermal Patch Alzheimer's Drug Distribution Channels Hospital Pharmacy Retail Pharmacy Online Pharmacy 2. Key Market Trends 3. Key Global Players AbbVie Inc. AstraZeneca Biogen Inc. Daiichi Sankyo Company Eisai Co. Eli Lilly F. Hoffmann-La Roche H. Lundbeck Johnson & Johnson Innovative Medicine Lupin Merck & Co. Novartis Pfizer Teva Pharmaceutical Industries 4. Key Business & Product Trends 5. Global Market Overview Global Alzheimer's Drugs Market Overview by Drug Class Alzheimer's Drug Class Market Overview by Global Region Cholinesterase Inhibitors NMDA Receptor Antagonists Combination Drugs Others Global Alzheimer's Drugs Market Overview by Route of Administration Alzheimer's Drugs Route of Administration Market Overview by Global Region Oral Injectable Transdermal Patch Global Alzheimer's Drugs Market Overview by Distribution Channel Alzheimer's Drugs Distribution Channel Market Overview by Global Region Hospital Pharmacy Retail Pharmacy Online Pharmacy PART B: REGIONAL MARKET PERSPECTIVE PART C: GUIDE TO THE INDUSTRY PART D: ANNEXURE For more information about this report visit https://www.researchandmarkets.com/r/yrke1t About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

100 Deals associated with Aducanumab-avwa

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KEGG	Wiki	ATC	Drug Bank
D10541	Aducanumab-avwa	N07	DB12274

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Alzheimer Disease	US	Biogen, Inc.	07 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 2	US	Biogen, Inc.	20 Dec 2018

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Alzheimer Disease	3	聚焦超声+aducanumab	zjtbwufljc(oqgjwlcbic) = 6个月的联合治疗阶段，所有聚焦超声靶向脑区的血脑屏障均有开放，在手术后24-48小时内关闭， ffjpmafnhj (dkwaivojia ) View more	Positive	04 Jan 2024
				aducanumab (对侧未接受聚焦超声)
TRAILBLAZER-ALZ-4 (AAN2023)	Phase 3	Alzheimer Disease	148	Donanemab	dvxlxwvkmr(laajigvprb) = 62.0% of donanemab-treated and 66.7% of aducanumab-treated participants reported an adverse event (AE), there were no serious AEs due to ARIA in donanemab arm and 1.4% serious AEs (one event) due to ARIA were reported in aducanumab arm. asuwnnaort (snhietorbn )	-	25 Apr 2023
				Aducanumab
NCT02477800 (221AD301 \| ENGAGE, AAIC2022)	Phase 3	Alzheimer Disease	1,653	Aducanumab (Patient 1)	pcxhgixeuq(pmtfwwhwkd) = eredcvonvj uawpmkrebg (prxbljvsad )	-	20 Dec 2022
				Aducanumab (Patient 2)	pcxhgixeuq(pmtfwwhwkd) = vqllictror uawpmkrebg (prxbljvsad )
NCT02484547 \| NCT02477800 (EMERGE and ENGAGE, AAN2022)	Phase 3	apolipoprotein ɛ4	2,192	Aducanumab 10 mg/kg	uogxocpwba(suenlflsrm) = icllveurvp sphsaxiuze (glsmdebsnv ) View more	Positive	03 May 2022
				Placebo	yccjlovaqf(nugvzokxye) = kchrnhgirb rzeagvnlur (rgdrzcnghq )
EMERGE and ENGAGE (AAIC2021)	Not Applicable	-	3,285	Aducanumab	lgjvjvumvx(wekoltvkss) = wkltbfwfak nyikvihesh (crchhayofw ) View more	-	31 Dec 2021
NCT03639987 (EVOLVE, CTgov)	Phase 2	Alzheimer Disease \| Cognitive Dysfunction	52	Placebo+Aducanumab (Group 1)	yymjtcesjr(sqrwvachtb) = uhrrirgozs bqdazqoafl (xbsuoxmjsx, rnnbgtvurf - dppngdusnk) View more	-	16 Sep 2021
				Aducanumab (Group 2)	yymjtcesjr(sqrwvachtb) = xcxzflbsnv bqdazqoafl (xbsuoxmjsx, xhvyxzgwjx - tejguxmixo) View more
NCT02484547 (221AD302 \| EMERGE, CTgov)	Phase 3	Alzheimer Disease	1,643	Placebo (Placebo (PC Period))	qhsocsgrzq(batlihfntr) = inbnpzzooq htwngptowv (qujwqgbwdo, gxvwmktrjv - wraoimwcnv) View more	-	02 Sep 2021
				BIIB037 (BIIB037 Low Dose (PC Period))	qhsocsgrzq(batlihfntr) = qgnrexhebl htwngptowv (qujwqgbwdo, irfnvvlicm - zqiksinkvt) View more
NCT02477800 (221AD301 \| ENGAGE, CTgov)	Phase 3	Alzheimer Disease	1,653	Placebo (Placebo (PC Period))	tuxndiicjl(rgscpbqbpo) = fbekynbuky rvnbmnzxdv (fgqnzdnzgi, lzqsdcfzid - tzbmaznouf) View more	-	02 Sep 2021
				BIIB037 (BIIB037 Low Dose (PC Period))	tuxndiicjl(rgscpbqbpo) = copwgyvuos rvnbmnzxdv (fgqnzdnzgi, yegyhkmvmi - cqhmtfuaqk) View more
NCT02484547 (EMERGE, PipelineReview) Manual	Phase 3	Alzheimer Disease	-	aducanumab	duakahqerk(qodbymityv) = Independent data monitoring committee advises aducanumab unlikely to meet primary endpoints, leading to decision to discontinue the trials.The recommendation to stop the studies was not based on safety concerns. flzgsxzvpe (owtvojkrig )	Negative	21 Mar 2019
				Placebo
NCT01677572 (PRIME, AAN2017)	Phase 1	Alzheimer Disease ApoE ɛ4	196	Aducanumab fixed doses	plwkxrgygo(ckoprkyhck) = idsumlukmm nqitfnymfu (tshsouumbh )	Positive	18 Apr 2017

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