Study finds link between increased brain glucose levels and Alzheimer’s

A new study published yesterday in Alzheimer’s & Dementia: the Journal of the Alzheimer’s Association, found a link for the first time between abnormalities in the mechanism of glucose breakdown in the brain and the severity of tangles and amyloid plaques in the brain, as well as the commencement of visible symptoms of Alzheimer’s disease.

Credit: Juan Gaertner / Shutterstock.com
This National Institute on Aging-supported study analyzed the brain tissue samples at autopsy from participants involved in the Baltimore Longitudinal Study of Aging (BLSA). BLSA, which is one of the world’s longest-running scientific studies on human aging, records neurological, psychological as well as physical data of participants over many decades.
In the study, glucose levels in various areas of the brain, such as the temporal and frontal cortex that are prone to Alzheimer’s disease pathology as well as some resistant areas like the cerebellum, were evaluated.
The researchers investigated three different categories of BLSA participants during the study — (a) participants with Alzheimer’s symptoms throughout life and with confirmed pathology of Alzheimer’s disease, including neurofibrillary tangles and beta-amyloid protein plaques in the brain at the time of death; (b) those who lacked symptoms throughout life, yet had notable levels of Alzheimer’s pathology identified during the brain post-mortem; and (c) healthy controls.
The findings indicated discrete abnormalities in glycolysis, which is the major process involved in the breaking down of glucose in the brain, and provided evidence associating the severity of the abnormalities with the severity of the disease pathology.
Poorer glycolysis rates and increased levels of brain glucose were linked with more severe tangles and plaques in the brains of people affected with Alzheimer’s. Also, the more serious declines in brain glycolysis were associated with the manifestation of disease symptoms like memory issues during life.
Richard J. Hodes, M.D, the NIA Director, commented that this kind of research initiates novel ideas on how to investigate the connections between glycolysis, symptoms, and the disease pathology in escalating the search for better and more effective treatment and prevention methods for Alzheimer’s disease.
Even though the likenesses between Alzheimer’s and diabetes had been suspected for a long time, an evaluation of the link has remained difficult, as insulin is not required for the entry of glucose to the brain or to the neurons.
Glucose used by the brain was tracked by calculating ratios of the amino acids serine, alanine and glycine to glucose, which allowed the assessment of rates of the vital steps involved in glycolysis.
The researchers identified that in comparison with samples of normal brain tissue, the enzyme activities that controlled those vital glycolysis steps were lesser in Alzheimer’s cases.
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Putting an effective complaint and recall management system in place

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of their users.
In the context of medical devices; complaints are any communication made in writing, electronically or in verbal form about any of these aspects of a medical device after its release for the purpose of distribution: identity, quality, durability, reliability, safety, effectiveness, or performance
FDA and ISO standards

The FDA has a very clear and well-defined set of regulatory guidelines on complaint handling in the field of medical devices. These are set out in FDA 21 CFR 820.198. The FDA requires medical device companies to also comply with ISO 13485:2016 Section 8.2.2., which suggests what document procedures to put in place to ensure timely handling of complaints in a compliant manner. Just how seriously the FDA takes complaint handling can be gauged from the fact that deficiency in complaint handling is one of the top reasons quoted for issuance of 483’s by the FDA.
Although complying with these regulations is a part of regulatory requirements; these regulations only mention what needs to be done in order to maintain a complaint and recall management system; how to do it is left to the individual medical device company. These regulations specify the exact elements of a complaint handling system, such as maintaining complaint files, proceeding about the complaints in a timely manner, documenting verbal complaints, and so on. However, it is up to the medical device manufacturer to implement the complaint handling and recall system in such a manner that it is perfectly streamlined and organized to the point where the complaint is handled exactly in the manner prescribed.
Full learning on how to implement an effective and compliant complaint and recall management system
The ways by which medical device companies can do this to optimize their complaint handling mechanism will be the teaching from a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. At this seminar, John Kasoff, Director of Regulatory Affairs, Life-Tech, Inc. and Principal Consultant at Lean to Quality, LLC, who brings more than three decades of experience in Quality and Regulatory management, during which he has implemented and overseen quality system operations and assured compliance, at all companies of all sizes, from start-up to more than $100 million in revenue; will be the Director.

Please visit Putting an effective complaint and recall management system in place to enroll for this seminar and gain thorough understanding of how to put an effective complaint and recall management system in place. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
An activity that cuts across many cross functions
Jeff will emphasize the point that complaint handling is a highly coordinated, cross functional area for a medical device company’s Quality System. Almost all niche areas of the medical device company, such as customer service, sales and marketing, Regulatory Affairs, QA, R and D, and Quality Engineering, are involved in complaint handling. This makes the need for orchestrated coordination and synchrony between these departments a must, for if the complaint handling mechanism is not well lubricated; it is bound to make the complaint handling act a failure, inviting all the undesirable penal actions from the regulatory and enforcement agencies.
John will highlight the role and importance of each of these functions in complaint handling. In these, activities relating to defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications, will be discussed in detail.
Distinguishing between complaints and “non-complaints”
He will also explain what constitutes a complaint, and will suggest recommended practice on the ways of handling “non-complaint” feedback. He will also show how to apply risk management to a complaint handling system, and explain a specific risk management system to drive home this point.
A substantial part of this seminar will be spent on making a streamlined review of the regulations, at which the critical process requirements for compliance with the regulations will be examined in detail. Jeff will offer straightforward and compliant recommendations for the methods of documentation relating to complaint records, root cause investigations, and corrective actions, and show how to apply risk management principles to complaint investigation.
To join us for more information, get in touch

Precision medicine: From ‘one-size-fits-all’ to personalized healthcare

Imagine a future in which, rather than using symptoms to identify a disease, your genes, metabolism, and gut microbiome inform how your individual health is managed. This is the vision of precision medicine.

Traditional medicine uses symptoms to diagnose diseases, and drugs to treat these symptoms. But precision medicine aims to turn this concept on its head.
By identifying the factors that predispose a person to a particular disease and the molecular mechanisms that cause the condition, treatment and prevention strategies can be tailored to each individual. 
So, how do we get from traditional to precision medicine? Advances in genetics and molecular analysis techniques have been a deciding factor, as has getting patients involved with managing their own health.
However, is precision medicine going to revolutionize how we treat all medical conditions, or will it be the privilege of a select few?

Innovation drives precision medicine

To the National Institutes of Health (NIH), “[P]recision medicine is a revolutionary approach for disease prevention and treatment that takes into account individual differences in lifestyle, environment, and biology.”
Launched by President Barack Obama in 2015, the Precision Medicine Initiative “will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.”
Breakthroughs in molecular biology have been key to getting precision medicine off the ground.
Next-generation DNA sequencing is now routinely used to identify genetic mutations that drive specific cancers, and biomarkers that predict disease risk or how well a person will respond to a particular treatment are increasingly becoming reality in medical practice.
Cancer is the one area wherein precision medicine seems to be making significant headway. New therapies seek to target the specific cellular pathway that is being exploited by a cancer, with the view to making short the life of the tumor.
This approach is already being employed in clinical trials to treat patients with melanoma who have a mutation in the BRAF gene, as Medical News Today reported recently.
Are you ready to join us to Keep Growing Up

Learn any professional courses for $10 only

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