Alzheimer's Research & Therapy

Alzheimer's Research & Therapy: Linus Health Digital Clock and Recall Test Detects Early Cognitive Impairment in Over 80% of Patients Who Were Misclassified in Commonly Used Paper-Based Test

Retrieved on: 
Tuesday, February 13, 2024
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BOSTON, Feb. 13, 2024 /PRNewswire/ -- A proprietary cognitive assessment from Linus Health, a digital health company focused on enabling early detection of Alzheimer's and other dementias, outperforms the most commonly used paper-based assessment in detecting early mild cognitive impairment and dementia and with less ethnic and racial bias, according to a peer-reviewed study recently published in the prestigious medical journal Alzheimer's Research & Therapy.

Key Points: 
  • The body of research confirms the most recent findings that the DCR outperforms a commonly used traditional cognitive test, the MMSE, in detecting early signs of cognitive impairment, and is more accurate overall in classifying mild cognitive impairment and mild dementia.
  • More than 80% of Americans are unfamiliar with mild cognitive impairment, which can be an early stage of Alzheimer's Disease, according to the Alzheimer's Association.
  • Symptoms are also not always noticeable, leading to delayed screenings and potentially greater risk to patients' brain health.
  • In contrast, the DCR was able to detect cognitive impairment in more than 80% of those the MMSE misclassified.

Development of Prediction Model for Brain Amyloid-Beta Accumulation Using Wristband Sensor

Retrieved on: 
Friday, December 29, 2023
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TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.

Key Points: 
  • TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.
  • This model is expected to enable screening for brain Aβ accumulation, which is an important pathological factor of Alzheimer's disease*2 (AD), simply by collecting biological and lifestyle data from daily life.
  • The key to maximizing treatment effects of the medicine is detecting Abeta accumulation in the brain of patients with mild cognitive impairment before the onset of symptoms.
  • This machine learning model is able to predict brain Aβ accumulation using readily available non-invasive variables.

Eisai publishes additional detailed analyses from lecanemab phase 2b study

Retrieved on: 
Friday, March 31, 2023
Alzheimer's Research & Therapy, Alzheimer's disease, PET, Biomarker, MCI, Plasma, Eisai, Incidence, Amyloid-related imaging abnormalities, Patient, Immunoglobulin G, ADAS, Research, AD, OLE, Safety, Lecanemab, Pharmaceutical industry, Medical imaging, Dementia

STOCKHOLM, March 31, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today the publication of additional detailed analyses from the phase 2b clinical study (Study 201), evaluating the efficacy and safety of lecanemab for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD).

Key Points: 
  • STOCKHOLM, March 31, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today the publication of additional detailed analyses from the phase 2b clinical study (Study 201), evaluating the efficacy and safety of lecanemab for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD).
  • The data was published in three articles in peer-reviewed journals;
    Consistency of efficacy results across various clinical measures and statistical methods in phase 2b: Alzheimer's Research and Therapy
    ARIA (amyloid-related imaging abnormality) profile in phase 2b: Alzheimer's & Dementia: Translational Research and Clinical Interventions
    The phase 2b study of lecanemab was a multicenter, double-blind, placebo-controlled, trial conducted in 856 patients with early AD.
  • Detailed results on biomarker, cognitive, and clinical effects from the phase 2b study.
    "
  • The conclusion of the primary analysis of the lecanemab phase 2b study is strengthened by the consistently positive observations across multiple statistical models, efficacy endpoints, and time-points assessed.

Eisai publishes additional detailed analyses from lecanemab phase 2b study

Retrieved on: 
Friday, March 31, 2023
Alzheimer's Research & Therapy, Alzheimer's disease, PET, Biomarker, MCI, Plasma, Eisai, Incidence, Amyloid-related imaging abnormalities, Patient, Immunoglobulin G, ADAS, Research, AD, OLE, Safety, Lecanemab, Pharmaceutical industry, Medical imaging, Dementia

STOCKHOLM, March 31, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today the publication of additional detailed analyses from the phase 2b clinical study (Study 201), evaluating the efficacy and safety of lecanemab for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD).

Key Points: 
  • STOCKHOLM, March 31, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today the publication of additional detailed analyses from the phase 2b clinical study (Study 201), evaluating the efficacy and safety of lecanemab for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD).
  • The data was published in three articles in peer-reviewed journals;
    Consistency of efficacy results across various clinical measures and statistical methods in phase 2b: Alzheimer's Research and Therapy
    ARIA (amyloid-related imaging abnormality) profile in phase 2b: Alzheimer's & Dementia: Translational Research and Clinical Interventions
    The phase 2b study of lecanemab was a multicenter, double-blind, placebo-controlled, trial conducted in 856 patients with early AD.
  • Detailed results on biomarker, cognitive, and clinical effects from the phase 2b study.
    "
  • The conclusion of the primary analysis of the lecanemab phase 2b study is strengthened by the consistently positive observations across multiple statistical models, efficacy endpoints, and time-points assessed.

Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer's Disease Under the Accelerated Approval Pathway

Retrieved on: 
Tuesday, May 10, 2022
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While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022.

Key Points: 
  • While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022.
  • Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.
  • Study 201 explored the impact of treatment with lecanemab on reducing amyloid plaque and clinical decline.
  • Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD.

Eisai completes rolling submission to the FDA of lecanemab for early Alzheimer's disease under the accelerated approval pathway

Retrieved on: 
Tuesday, May 10, 2022
Development, University, Core, Biomarker, National Institute on Aging, Safety, Parkinson's disease, Caregiver, BAN2401, Pharmaceuticals and Medical Devices Agency, Person, Eisai, National, Medication, Ageing, CEO, Clarity, AD, Brain, CET, Patient, Partnership, Neurodegeneration, Clinical trial, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Biologics license application, Disease, Research, Alzheimer's Research & Therapy, Medicines and Healthcare products Regulatory Agency, Priority review, AB, Commercialization, Nasdaq Stockholm, Degenerative disease, BLA, PMDA, National Institute, MCI, Prescription Drug User Fee Act, Nasdaq, Food, Amyloid, Biogen, ADAS, Marketing, PDUFA, Autumn, Pharmaceutical industry, Medical imaging, Medical device, EU, Alzheimer's disease, Uppsala University

While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022.

Key Points: 
  • While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022.
  • Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA before the end of the first quarter 2023.
  • In June 2021, FDA granted lecanemab Breakthrough Therapy designation and in December 2021, FDA granted lecanemab Fast track designation.
  • Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease.

Eisai completes rolling submission to the FDA of lecanemab for early Alzheimer's disease under the accelerated approval pathway

Retrieved on: 
Tuesday, May 10, 2022
Development, University, Core, Biomarker, National Institute on Aging, Safety, Parkinson's disease, Caregiver, BAN2401, Pharmaceuticals and Medical Devices Agency, Person, Eisai, National, Medication, Ageing, CEO, Clarity, AD, Brain, CET, Patient, Partnership, Neurodegeneration, Clinical trial, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Biologics license application, Disease, Research, Alzheimer's Research & Therapy, Medicines and Healthcare products Regulatory Agency, Priority review, AB, Commercialization, Nasdaq Stockholm, Degenerative disease, BLA, PMDA, National Institute, MCI, Prescription Drug User Fee Act, Nasdaq, Food, Amyloid, Biogen, ADAS, Marketing, PDUFA, Autumn, Pharmaceutical industry, Medical imaging, Medical device, EU, Alzheimer's disease, Uppsala University

While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022.

Key Points: 
  • While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022.
  • Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA before the end of the first quarter 2023.
  • In June 2021, FDA granted lecanemab Breakthrough Therapy designation and in December 2021, FDA granted lecanemab Fast track designation.
  • Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease.

DGAP-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. Reports Q3 2021 Financial Results and Highlights Operational Progress

Retrieved on: 
Thursday, November 4, 2021
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"Throughout the third quarter, we made significant progress towards filling the gap of safe, widely available effective disease-modifying therapies in Alzheimer's disease.

Key Points: 
  • "Throughout the third quarter, we made significant progress towards filling the gap of safe, widely available effective disease-modifying therapies in Alzheimer's disease.
  • VIVIAD remains on track for an interim safety readout in mid-22 and Vivoryon continues to anticipate final data in the second half of 2023.
  • Research and development expenses incurred for the nine months ended September 30, 2021 increased over the corresponding period in 2020 by EUR 3.6 million.
  • General and administrative expenses increased by EUR 1.2 million for the nine months ended September 30, 2021.

DGAP-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics Provides Update on Business and Progress of Varoglutamstat Clinical Development in Alzheimer's Disease

Retrieved on: 
Monday, October 18, 2021
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Patients will then be treated for a minimum of 48 weeks on the selected dose twice daily vs. placebo.

Key Points: 
  • Patients will then be treated for a minimum of 48 weeks on the selected dose twice daily vs. placebo.
  • A composite Neuropsychological Test Battery (NTB) score will be administered throughout the study in order to assess cognitive efficacy.
  • Secondary endpoints include long-term safety and tolerability of varoglutamstat and its efficacy on brain activity, cognition and activities of daily living.
  • "We are following a diligently designed development strategy and making continued progress towards overcoming the challenges of drug development in AD, moving varoglutamstat through clinical development as efficiently as possible," said Dr. Ulrich Dauer, CEO of Vivoryon.

DGAP-News: Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. Reports H1 2021 Financial Results and Operational Progress

Retrieved on: 
Tuesday, September 21, 2021
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"In the first half of 2021, we made significant progress towards bringing our lead candidate varoglutamstat to patients suffering from Alzheimer's disease.

Key Points: 
  • "In the first half of 2021, we made significant progress towards bringing our lead candidate varoglutamstat to patients suffering from Alzheimer's disease.
  • In the first two quarters of 2021, research and development expenses amounted to EUR 9,456 k (H1 2020: EUR 6,380 k).
  • This increase was mainly driven by higher expenses for production (H1 2021: EUR 4,194 k, H1 2020: EUR 1,876 k), expenses for share-based payments (H1 2021: EUR 464 k, H1 2020: EUR 3 k) and higher costs associated with basic research projects in connection with Meprin (H1 2021: EUR 220 k, H1 2020: nil) and cancer (H1 2021: EUR 162 k, H1 2020: nil).
  • This increase is largely attributable to costs for consulting (H1 2021: EUR 1,030 k, H1 2020: EUR 481 k) and expenses for share based payments (2021: EUR 464 k, 2020: nil).