Amyloid-related imaging abnormalities

Hyperfine, Inc. Takes the Stage at ISMRM with Seventeen Abstracts Assessing the Potential of Using Swoop® System Images Across Multiple Care Settings and Clinical Conditions

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화요일, 4월 23, 2024
Medical Devices, Health, Neurology, Health Technology, Clinical Trials, Radiology, FDA, Brain, International Society, Amyloid-related imaging abnormalities, ARIA, Abstract, Conference, CARE, Patient, Magnetic resonance, Observational study, Physician, Multiple sclerosis, Hyperfine structure, Biomarker, Medical imaging

These seventeen abstracts span a wide variety of use cases, including two that highlight the utility of brain images acquired with the ultra-low-field Swoop® Portable MR Imaging® system to aid physicians screening for various biomarkers and monitoring disease progression unique to neurodegenerative diseases, including Alzheimer’s and multiple sclerosis (MS).

Key Points: 
  • These seventeen abstracts span a wide variety of use cases, including two that highlight the utility of brain images acquired with the ultra-low-field Swoop® Portable MR Imaging® system to aid physicians screening for various biomarkers and monitoring disease progression unique to neurodegenerative diseases, including Alzheimer’s and multiple sclerosis (MS).
  • Conference attendees can learn more during these select presentations:
    “These abstracts are very encouraging.
  • Earlier this month, the company announced that the first patients have been scanned in the CARE PMR (Capturing ARIA Risk Equitably with Portable MR) study.
  • For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.

Leading Institutions Enroll First Alzheimer’s Patients Receiving Amyloid-Targeting Therapy in CARE PMR Study

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수요일, 4월 17, 2024
Medical Devices, FDA, Health, Health Technology, Clinical Trials, General Health, Brain, Patient, Bleeding, Amyloid-related imaging abnormalities, Mass, ARIA, Workflow, Dementia, CARE, DRS, Radiology, Observational study, Physician, PMR, MRI, Multimedia, Hyperfine structure, Mass General Brigham, Medical imaging

Patients with Alzheimer’s can now be treated with amyloid-targeting therapy, which reduces the amyloid plaque burden in the brain.

Key Points: 
  • Patients with Alzheimer’s can now be treated with amyloid-targeting therapy, which reduces the amyloid plaque burden in the brain.
  • Teresa Gomez-Isla and W. Taylor Kimberly, will evaluate the Swoop® system to understand its potential role in the overall continuum of Alzheimer’s care.
  • “The newly approved amyloid-targeting therapy represents a major milestone in the global fight against Alzheimer’s, bringing hope of additional years of independent living to patients.
  • The required MRI scans to image brain abnormalities in patients receiving amyloid-targeting therapy present workflow challenges for patients and providers,” said Hyperfine, Inc. President and CEO Maria Sainz.

Cognito Therapeutics Announces Spectris™ OVERTURE OLE Study Data Supports Potential Disease Modification and Early Treatment in Alzheimer’s Disease

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월요일, 3월 11, 2024
Software, Research, Hardware, Pharmaceutical, Data Management, Technology, Medical Devices, Clinical Trials, Science, Neurology, Biotechnology, Health, Other Science, Cognito, Conference, MRI, HOPE, Parkinson's disease, Disease, Patient, Amyloid-related imaging abnormalities, OLE, ARIA, Clinical trial, Therapy, Safety, WBV, Pharmaceutical industry

The results support for Spectris’™ potential as a disease modifying therapy that, if approved, could also be used as an early intervention for the treatment of Alzheimer’s Disease (AD).

Key Points: 
  • The results support for Spectris’™ potential as a disease modifying therapy that, if approved, could also be used as an early intervention for the treatment of Alzheimer’s Disease (AD).
  • These results provide support for the potential safety of prolonged treatment and highlight the potential for Spectris as a potential disease modifying therapy to preserve both brain structure and function in patients with AD,” said Brent Vaughan, CEO of Cognito Therapeutics.
  • 83% of the OVERTURE study patients (44/53) entered a separate 12-month open label extension (OLE) study, which allowed for further evaluation of Spectris’ potential as a disease modifying therapy.
  • “These results are consistent with accepted criteria for disease modification and support potential for use as early treatment of AD.

Alector Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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화요일, 2월 27, 2024
PD, GSK, Arnon Rosenthal, Investment, Interest, ARIA, AbbVie, Webcast, Plasma, PET, MRI, Central nervous system, Traffic barrier, GPNMB, Cerebrospinal fluid, Breakthrough therapy, ALEC, Frontotemporal dementia, FTD, DSM-IV codes, European Medicines Agency, Food and Drug Administration, Canadian International Council, Brain, SAN, Total, LTE, Amyloid-related imaging abnormalities, Alector, ALS, AAIC, PROGRESS, ABC, Manuscript, Conference, Safety, Biomarker, Patent, CSF, Mutation, IND, Microglia, European Patent Convention, Insurance, PIN, FDA, Food, Risk, TREM2, Dementia, Disease, Pharmaceutical industry

Alector and GSK are co-developing AL101 for the potential treatment of more prevalent neurodegenerative diseases, including AD and Parkinson’s disease.

Key Points: 
  • Alector and GSK are co-developing AL101 for the potential treatment of more prevalent neurodegenerative diseases, including AD and Parkinson’s disease.
  • In September 2023, Alector completed enrollment of 381 participants in the randomized, double-blind, placebo-controlled, dose-ranging, INVOKE-2 Phase 2 clinical trial.
  • In July 2023, Alector presented an update on INVOKE-2 at the Alzheimer’s Association International Conference (AAIC).
  • Alector’s management team will host a conference call discussing Alector’s results for the fourth quarter and full year 2023 and provide a business update.

Denali Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

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화요일, 2월 27, 2024
MPS II, Hearing, ARIA, Antibody, LRRK2, PTV, IDS, Transferrin receptor, MAPT, Traffic barrier, ALS, Hunting, Dermatan sulfate, Therapy, BBB, SAN, Total, Amyloid-related imaging abnormalities, Alpha-synuclein, COMPASS, ETV, Hunter syndrome, Neurodegenerative disease, Conference, MPS, Safety, Biomarker, OTV, LUMA, AFL, SNCA, Amyloid beta, CSF, PIPE, Glycogen storage disease, Research, ATV, FDA, Food, Risk, Sanofi, UC, CD98, Patient, Cognition, Oligonucleotide, Science, Alfa, Pharmaceutical industry

Enrollment continues in the global Phase 2/3 COMPASS study and is expected to be completed in 2024.

Key Points: 
  • Enrollment continues in the global Phase 2/3 COMPASS study and is expected to be completed in 2024.
  • Sanofi intends to present the detailed efficacy and safety results of the ALS Phase 2 HIMALAYA study at a future scientific forum.
  • There was no collaboration revenue for the quarter ended December 31, 2023, compared to $10.3 million for the quarter ended December 31, 2022.
  • Further, for the quarter ended December 31, 2023, there was also a decrease in other unallocated research and development expenses as a result of reduced facility costs.

Cognito Therapeutics OVERTURE Clinical Trial in Alzheimer's Disease Published in Frontiers in Neurology

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수요일, 3월 6, 2024
Technology, Medical Devices, General Health, Neurology, Science, Consumer, Clinical Trials, Biotechnology, Health, Health Technology, Other Science, Research, Software, Hardware, Pharmaceutical, Data Management, Seniors, Cognito, Caregiver, Amyloid-related imaging abnormalities, Aes, HOPE, Alzheimer's disease, Political moderate, ARIA, Safety, Hope, Therapy, Memory, EEG, Tolerability, Patient, Clinical trial, Atrophy, MRI, Medical imaging

Cognito Therapeutics , a leader in technology-based therapeutic interventions for neurodegenerative diseases, announced today the publication of the OVERTURE study results in Frontiers in Neurology .

Key Points: 
  • Cognito Therapeutics , a leader in technology-based therapeutic interventions for neurodegenerative diseases, announced today the publication of the OVERTURE study results in Frontiers in Neurology .
  • The OVERTURE clinical trial was a randomized, double-blind, sham-controlled clinical trial conducted over a six-month period at 5 US clinical trial sites, involving participants with mild to moderate AD.
  • Participants were randomly assigned 2:1 to receive self-administered daily, one-hour Spectris therapy designed to evoke EEG-verified gamma oscillations or sham treatment.
  • “Publication of OVERTURE clinical trial results is an important step in our commitment to develop our technology-based therapeutic intervention in Alzheimer’s disease,” said Ralph Kern, M.D., MHSc, Chief Medical Officer of Cognito Therapeutics.

Denali Therapeutics Announces Key Anticipated 2024 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases

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월요일, 1월 8, 2024
CSF, Lysosomal storage disease, Cerebrospinal fluid, Risk, Sanfilippo syndrome, Amyloid, BBB, UC, Sanfilippo, Manuscript, ETV, ALS, OTV, SNCA, IDS, Asos, Conference, Cognition, RIPK1, Fluid mechanics, Neuroinflammation, Premedication, Glycogen storage disease, Amyloid beta, SGSH, Therapy, COMPASS, Traffic barrier, Hunting, N-sulfoglucosamine sulfohydrolase, Hunter syndrome, ISR, NewCo, Amyloid-related imaging abnormalities, Inflammation, CNS, Neurodegenerative disease, Takeda, Biomarker, Alpha-synuclein, K2, Biology, DSM-IV codes, LUMA, Brain, MPS, Investigational New Drug, PTV, ARIA, Nerve, AFL, Pathology, MPS II, Interim, BioRxiv, Plaque, MAPT, LRRK2, Elevator mechanic

The global Phase 2/3 COMPASS study continues to recruit up to 54 participants with neuronopathic and non-neuronopathic MPS II.

Key Points: 
  • The global Phase 2/3 COMPASS study continues to recruit up to 54 participants with neuronopathic and non-neuronopathic MPS II.
  • Upon completion of the ongoing Phase 1/2 study, and together with data from COMPASS, this combined data package is intended to support registration.
  • Increased RIPK1 activity in the CNS is hypothesized to drive neuroinflammation and cell necroptosis and to contribute to neurodegeneration.
  • Denali will maintain ownership of and continue to advance its current portfolio of clinical stage small molecule programs.

"LEQEMBI Intravenous Infusion"Lecanemab) for the Treatment of Alzheimer's Disease to be Launched in Japan on December 20

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목요일, 12월 14, 2023
Marketing, Alzheimer's disease, Caregiver, Government, Radiology, Disease, Pharmacist, Brain, Amyloid-related imaging abnormalities, ARIA, Nursing, Ministry, Patient, Diagnosis, MCI, NHI

The launch in Japan marks the second country to have LEQEMBI on the market, following the U.S.

Key Points: 
  • The launch in Japan marks the second country to have LEQEMBI on the market, following the U.S.
  • In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.
  • In consideration of the importance of Alzheimer's disease in Japan, we believe it is imperative that such pathways be established.
  • We are committed to taking this first step towards changing the future of Alzheimer's disease together with our stakeholders."

Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA)

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월요일, 11월 20, 2023
DSM-IV codes, Senior, Authorization, Alzheimer's disease, Dementia, MRI, MLS, Amyloid-related imaging abnormalities, Marketing, EMA, WHO, European, Brain, Doctor of Philosophy, World Health Organization, Cerebral edema, ARIA, European Medicines Agency, Regulatory affairs, Marketing authorisation, Pathology, Amyloid, Patient, Therapy, Medical imaging

These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.

Key Points: 
  • These meetings discussed the debilitating pathology of Alzheimer’s disease and Anavex’s blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results, including data obtained in the ANAVEX®2-73-AD-004 study.
  • Pursuant to discussion at the meetings, Anavex initiated the process for submitting a Marketing Authorisation application to the EMA with the submission of the Centralised Procedure request with the goal of the Authorisation allowing direct access to the market of the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
  • In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.
  • Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.

LEQEMBI® to be launched in Japan for Alzheimer's disease on December 20

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수요일, 12월 13, 2023
Ministry of Health (Kuwait), Ministry, Brain, Risk management, Amyloid-related imaging abnormalities, Disease, Risk, History, Patient, CET, Intraparenchymal hemorrhage, Eisai, MCI, Alzheimer's disease, Marketing, Horseshoe kidney, Co-promotion, Ageing, ARIA, Hypersensitivity, NHI, HIV disease progression rates, Lecanemab, Medical device, Pharmaceutical industry, Residential care, Biogen, Health

LEQEMBI obtained manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in Japan on September 25, 2023.

Key Points: 
  • LEQEMBI obtained manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in Japan on September 25, 2023.
  • The launch, planned for December 20, will make Japan the second country to have the product on the market, following the U.S.
    "This is a great Christmas present!
  • Alzheimer's disease patients in Japan will now have access to the first disease modifying treatment.
  • This gives hope for the large aging population in Japan with a great need for new treatment options," says Gunilla Osswald, CEO of BioArctic.