Breaking News
April 26, 2019 - Can Obesity Shrink Your Brain?
April 26, 2019 - This oral appliance could help you (and your partner) sleep better
April 26, 2019 - Myelination deficits cause abnormal hypersocial behavior associated with Williams syndrome
April 26, 2019 - New sepsis detector uses photonics to make accurate diagnosis in less than thirty minutes
April 26, 2019 - New study describes process to diagnose rare genetic diseases in record time
April 26, 2019 - Scientists and patients gather in Vancouver to discuss about Stevens-Johnson syndrome
April 26, 2019 - Advance in breakthrough cancer treatment eliminates serious side effects
April 26, 2019 - Discovery about cold sensing could pave way for new pain relief drugs
April 26, 2019 - Children often turn to sugary drinks instead of water
April 26, 2019 - Genome analysis shows the combined effect of many genes on cognitive traits
April 26, 2019 - Patients Caught In Middle Of Fight Between Health Care Behemoths
April 26, 2019 - Drug overdoses among adolescents and young adults on the rise
April 26, 2019 - Implementing a Paperless QC Micro Laboratory”
April 25, 2019 - Obesity linked to a reduction in gray matter
April 25, 2019 - Smart assistants could help combat opioid crisis
April 25, 2019 - Diagnostic stewardship strategy reduces inappropriate testing
April 25, 2019 - Three-antibiotic cocktail eradicates ‘persister’ Lyme bacteria in mouse model
April 25, 2019 - Study investigates how early blindness shapes sound processing
April 25, 2019 - Outcomes Worse for Cancer Patients Seen at Noncancer EDs
April 25, 2019 - Link found between temperament of high-risk infants and obesity
April 25, 2019 - Al Letson explores ties between journalists and doctors at Medicine and the Muse symposium
April 25, 2019 - New mobile phone game can detect people at risk of Alzheimer’s
April 25, 2019 - Scientists discover trigger region for absence epileptic seizures
April 25, 2019 - Stretchy wearable patch can do a health check while you work out
April 25, 2019 - Exercise activates brain circuits associated with memory in older adults
April 25, 2019 - Veggies, Fruits and Grains Keep Your Heart Pumping
April 25, 2019 - Healthy meal kits can boost children’s long-term health
April 25, 2019 - Designing an inexpensive surgical headlight: A Q&A with a Stanford surgeon
April 25, 2019 - States Weigh Banning A Widely Used Pesticide Even Though EPA Won’t
April 25, 2019 - Integrator complex proteins are crucial for healthy brain development in fruit flies, study finds
April 25, 2019 - Device converts brain signals into speech, offering hope for patients
April 25, 2019 - Measles vaccination rates are a ‘public health time bomb’
April 25, 2019 - Maths made easier for scientists students who shun the subject wins award
April 25, 2019 - Researchers decode how cancer drug works in brains of Parkinson’s disease patients
April 25, 2019 - Smarter Brain Cancer Trial Comes to Columbia
April 25, 2019 - Researchers Seek Sage Advice Of Elders On Aging Issues
April 25, 2019 - New chemical synthesis strategy leads to identification of novel, simpler derivatives
April 25, 2019 - Vanderbilt investigators discover link between vascular biology and eye disease
April 25, 2019 - Feces transplantation is effective and provides economic benefits
April 25, 2019 - Eisenhower Health first in Southern California to offer new lung valve treatment for COPD/emphysema
April 25, 2019 - Johns Hopkins researchers uncover role of neurotransmitter in the spread of aggressive cancers
April 25, 2019 - Porvair Sciences offers highly effective P3 microplate for biological sample clean-up
April 25, 2019 - Air pollution increases risk for respiratory hospitalization among childhood cancer survivors
April 25, 2019 - We are sitting more! How bad is that?
April 25, 2019 - Majority of stroke survivors not screened for osteoporosis, despite increased risk
April 25, 2019 - ADHD Screening: MedlinePlus Lab Test Information
April 25, 2019 - Cellular alterations increase vulnerability of obese and diabetic individuals to infection
April 25, 2019 - Association Insurance Pushes On Despite Court Ruling
April 25, 2019 - Traditional and e-cigarette users may be more receptive to smoking cessation interventions
April 25, 2019 - Delving into tumor’s cellular lineage may offer clues for customized therapies
April 25, 2019 - Two studies uncover brain mechanisms underlying decision making process
April 25, 2019 - Cardiometabolic Risk Better ID’d in Children Reclassified to Higher BP
April 25, 2019 - How the obesity epidemic is taking a toll on our bones and joints
April 25, 2019 - E-cigarettes contaminated with dangerous microbial toxins
April 25, 2019 - Researchers document specific characteristics of storefront tobacco advertisements
April 25, 2019 - Oncotype DX-guided treatment could reduce cost for breast cancer care, study suggests
April 25, 2019 - Predicting whether a patient will benefit from chemotherapy
April 25, 2019 - New review highlights how lifestyle affects our genes
April 25, 2019 - Study provides evidence that blood tests can detect Alzheimer’s risk
April 25, 2019 - Computer program mimics natural speech using brain signals from epilepsy patients
April 25, 2019 - Physicians turning to antibiotic alternatives for long-term acne treatment
April 25, 2019 - Preschool Is Prime Time to Teach Healthy Lifestyle Habits
April 25, 2019 - Study finds insidious and persistent discrimination among physician mothers
April 25, 2019 - Newly identified skin-gut communication helps illuminate link between food allergy and eczema
April 25, 2019 - Thiazide use linked with reduced risk of low energy fractures in people with Alzheimer’s
April 25, 2019 - Some women are biologically more resilient than others to PTSD
April 25, 2019 - The Current issue of “The view from here” is concerned with Partnerships and Alliances
April 25, 2019 - Imaging method reveals long-lived patterns in cells of the eye
April 25, 2019 - Podcast: KHN’s ‘What The Health?’ The Abortion Wars Rage On
April 25, 2019 - Prolonged exposure therapy is more effective in treating veterans with PTSD, alcohol use disorder
April 24, 2019 - Our artificial cornea breakthrough could lead to self-assembling organs
April 24, 2019 - A Stanford black, female, gay surgery resident speaks out
April 24, 2019 - Donna Lynne on Extreme Sports, Lessons From the '60s, and Taking CUIMC to the Next Level
April 24, 2019 - Pain Clinics’ Doctors Needlessly Tested Hundreds Of Urine Samples, Court Records Show
April 24, 2019 - Researchers uncover potential clue to halt destruction of nerve cells in people with ALS
April 24, 2019 - Study uncovers reasons for poor mental health in bisexual people
April 24, 2019 - Screenings, interventions, and referrals can help adolescents overcome substance abuse
April 24, 2019 - Febrile seizures following vaccination are self-resolving and not dangerous
April 24, 2019 - Flow-UV inline UV-Visible spectrometer monitors dispersion in real time
April 24, 2019 - Rates of Marijuana Use in Cancer Patients on the Rise in U.S.
Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

image_pdfDownload PDFimage_print

Biogen and Eisai Co., Ltd. announced results from a recent analysis of the ongoing long-term extension (LTE) Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up to 36 months in the titration cohort and up to 48 months in the fixed-dose cohorts. The results are generally consistent with previous interim analyses, and there were no changes to the risk-benefit profile of aducanumab.

The Phase 1b study is a randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical effects of aducanumab in patients with prodromal AD or mild AD dementia. The study includes fixed dosing at 1, 3, 6 and 10 mg/kg as well as an arm with a titration regimen in which patients received a gradually increased dose of aducanumab until they reach a maximum dose of 10 mg/kg.

In the Phase 1b study 196 patients received aducanumab or placebo, of which 143 patients entered the LTE. The LTE cohorts were allocated across six dosing arms including: placebo switchers, 1 mg/kg switchers to 3 mg/kg, fixed doses (3 mg/kg, 6 mg/kg, 10 mg/kg) and titration. Additionally, there were discontinuations as expected in studies of 36 or more months. As a result, there are small patient numbers in the new analyses.

The results for each dose arm are generally consistent with previous interim analyses. Amyloid plaque levels as measured by positron emission tomography (PET) continued to decrease in a dose- and time- dependent manner in patients from the titration cohort at 36 months and fixed-dose cohorts at 48 months. Amyloid plaque levels in the 10 mg/kg fixed-dose at 48 months remained at a level considered below the quantitative cut point that discriminates between a positive and negative scan. Analyses of exploratory clinical endpoints Clinical Dementia Rating Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) suggest a continued benefit on the rate of clinical decline over 36 months and 48 months, respectively. Clinical effects with titrated aducanumab in the second year of the LTE were generally consistent with findings in the 10 mg/kg fixed-dose cohorts.

Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced amyloid imaging abnormalities (ARIA)-E (edema). Eight patients experienced more than one episode of ARIA-E. The majority of ARIA events occurred early in the course of treatment; they were typically mild radiographically (MRI), clinically asymptomatic and resolved or stabilized within 4-12 weeks, with most patients continuing treatment. In the Phase 1b LTE, the most commonly reported adverse events were headache, fall and ARIA.

Source:

http://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-report-data-long-term-extension-phase-1b-study

Posted in: Drug Trial News | Medical Condition News

Tags: Alzheimer’s Disease, Amyloid Plaque, Antibody, Biogen, Biotechnology, Compound, Dementia, Edema, Headache, Health Care, Imaging, Manufacturing, Monoclonal Antibody, Movement disorders, Multiple Sclerosis, Muscular Atrophy, Neurodegenerative Diseases, Neuroimmunology, Neurology, Neuroscience, Oncology, Ophthalmology, Pain, Pharmacodynamics, Pharmacokinetics, Placebo, Positron Emission Tomography, Research, Sclerosis, Spinal Muscular Atrophy, Titration

Tagged with:

About author

Related Articles