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Alzheimer’s Diagnostic Guidelines Updated for First Time in 27 Years

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For the first time in 27 years, clinical diagnostic criteria for Alzheimer’s disease dementia have been revised, and research guidelines for earlier stages of the disease have been characterized to reflect a deeper understanding of the disorder.

The National Institute on Aging/Alzheimer’s Association Diagnostic Guidelines for Alzheimer’s Disease outline some new approaches for clinicians and provides scientists with more advanced guidelines for moving forward with research on diagnosis and treatments. They mark a major change in how experts think about and study Alzheimer’s disease. Development of the new guidelines was led by the National Institutes of Health and the Alzheimer’s Association.

The original criteria were the first to address the disease and described only later stages, when symptoms of dementia are already evident. The updated guidelines announced today cover the full spectrum of the disease as it gradually changes over many years. They describe the earliest preclinical stages of the disease, mild cognitive impairment, and dementia due to Alzheimer’s pathology. Importantly, the guidelines now address the use of imaging and biomarkers in blood and spinal fluid that may help determine whether changes in the brain and those in body fluids are due to Alzheimer’s disease. Biomarkers are increasingly employed in the research setting to detect onset of the disease and to track progression, but cannot yet be used routinely in clinical diagnosis without further testing and validation.

“Alzheimer’s research has greatly evolved over the past quarter of a century. Bringing the diagnostic guidelines up to speed with those advances is both a necessary and rewarding effort that will benefit patients and accelerate the pace of research,” said National Institute on Aging Director Richard J. Hodes, M.D.

“We believe that the publication of these articles is a major milestone for the field,” said William Thies, Ph.D., chief medical and scientific officer at the Alzheimer’s Association. “Our vision is that this process will result in improved diagnosis and treatment of Alzheimer’s, and will drive research that ultimately will enable us to detect and treat the disease earlier and more effectively. This would allow more people to live full, rich lives without — or with a minimum of — Alzheimer’s symptoms.”

The new guidelines appear online April 19, 2011 in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. They were developed by expert panels convened last year by the National Institute on Aging (NIA), part of the NIH, and the Alzheimer’s Association. Preliminary recommendations were announced at the Association’s International Conference on Alzheimer’s Disease in July 2010, followed by a comment period.

Guy M. McKhann, M.D., Johns Hopkins University School of Medicine, Baltimore, and David S. Knopman, M.D., Mayo Clinic, Rochester, Minn., co-chaired the panel that revised the 1984 clinical Alzheimer’s dementia criteria. Marilyn Albert, Ph.D., Johns Hopkins University School of Medicine, headed the panel refining the MCI criteria. Reisa A. Sperling, M.D, Brigham and Women’s Hospital, Harvard Medical School, Boston, led the panel tasked with defining the preclinical stage. The journal also includes a paper by Clifford Jack, M.D., Mayo Clinic, Rochester, Minn., as senior author, on the need for and concept behind the new guidelines.

The original 1984 clinical criteria for Alzheimer’s disease, reflecting the limited knowledge of the day, defined Alzheimer’s as having a single stage, dementia, and based diagnosis solely on clinical symptoms. It assumed that people free of dementia symptoms were disease-free. Diagnosis was confirmed only at autopsy, when the hallmarks of the disease, abnormal amounts of amyloid proteins forming plaques and tau proteins forming tangles, were found in the brain.

Since then, research has determined that Alzheimer’s may cause changes in the brain a decade or more before symptoms appear and that symptoms do not always directly relate to abnormal changes in the brain caused by Alzheimer’s. For example, some older people are found to have abnormal levels of amyloid plaques in the brain at autopsy yet never showed signs of dementia during life. It also appears that amyloid deposits begin early in the disease process but that tangle formation and loss of neurons occur later and may accelerate just before clinical symptoms appear.

To reflect what has been learned, the National Institute on Aging/Alzheimer’s Association Diagnostic Guidelines for Alzheimer’s Disease cover three distinct stages of Alzheimer’s disease:

  • Preclinical — The preclinical stage, for which the guidelines only apply in a research setting, describes a phase in which brain changes, including amyloid buildup and other early nerve cell changes, may already be in process. At this point, significant clinical symptoms are not yet evident. In some people, amyloid buildup can be detected with positron emission tomography (PET) scans and cerebrospinal fluid (CSF) analysis, but it is unknown what the risk for progression to Alzheimer’s dementia is for these individuals. However, use of these imaging and biomarker tests at this stage are recommended only for research. These biomarkers are still being developed and standardized and are not ready for use by clinicians in general practice.
  • Mild Cognitive Impairment (MCI) — The guidelines for the MCI stage are also largely for research, although they clarify existing guidelines for MCI for use in a clinical setting. The MCI stage is marked by symptoms of memory problems, enough to be noticed and measured, but not compromising a person’s independence. People with MCI may or may not progress to Alzheimer’s dementia. Researchers will particularly focus on standardizing biomarkers for amyloid and for other possible signs of injury to the brain. Currently, biomarkers include elevated levels of tau or decreased levels of beta-amyloid in the CSF, reduced glucose uptake in the brain as determined by PET, and atrophy of certain areas of the brain as seen with structural magnetic resonance imaging (MRI). These tests will be used primarily by researchers, but may be applied in specialized clinical settings to supplement standard clinical tests to help determine possible causes of MCI symptoms.
  • Alzheimer’s Dementia — These criteria apply to the final stage of the disease, and are most relevant for doctors and patients. They outline ways clinicians should approach evaluating causes and progression of cognitive decline. The guidelines also expand the concept of Alzheimer’s dementia beyond memory loss as its most central characteristic. A decline in other aspects of cognition, such as word-finding, vision/spatial issues, and impaired reasoning or judgment may be the first symptom to be noticed. At this stage, biomarker test results may be used in some cases to increase or decrease the level of certainty about a diagnosis of Alzheimer’s dementia and to distinguish Alzheimer’s dementia from other dementias, even as the validity of such tests is still under study for application and value in everyday clinical practice.

The panels purposefully left the guidelines flexible to allow for changes that could come from emerging technologies and advances in understanding of biomarkers and the disease process itself.

“The guidelines discuss biomarkers currently known, and mention others that may have future applications,” said Creighton H. Phelps, Ph.D., of the NIA Alzheimer’s Disease Centers Program. “With researchers worldwide striving to develop, validate and standardize the application of biomarkers at every stage of Alzheimer’s disease, we devised a framework flexible enough to incorporate new findings.”

Source: NIH

Scientists ID Gene that May Hold Key to Muscle Repair

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Researchers have long questioned why patients with Duchenne muscular dystrophy (DMD) tend to manage well through childhood and adolescence, yet succumb to their disease in early adulthood, or why elderly people who lose muscle strength following bed rest find it difficult or impossible to regain.

Now, researchers are beginning to find answers in a specialized population of cells called satellite cells. Their findings, reported in the journal Genes & Development, suggest a potential therapeutic target for conditions where muscle deterioration threatens life or quality of life.

Key to the development of skeletal muscle of the embryo and fetus, satellite cells continue to actively increase muscle mass through infancy. After that, they decrease in number and become quiescent, or inactive, until they are activated by injury or degeneration to proliferate. The process, which enables the body to repair damaged muscle, works quite well — to a point, says Vittorio Sartorelli, M.D., senior investigator in the NIAMS Laboratory of Muscle Stem Cells and Gene Regulation and lead author of the study.

For example, when a young person experiences muscle loss after a period of inactivity, muscle rebuilds as soon as activity is resumed. However, in the elderly, muscles lose that capacity. Similarly, in patients with DMD, the initial phases of muscle degeneration are effectively counteracted by the ability of satellite cells to regenerate.

“That is why people can survive until they are 20 years old without much of a problem, but, at a certain point, satellite cells stop proliferating,” said Dr. Sartorelli. “That is the point at which the patient will start developing weakness and problems that will ultimately lead to death.”

Suspecting a genetic switch that might turn off satellite cell proliferation in these circumstances, the scientists looked to a gene called Ezh2, known to keep the activity of other genes in check. When they genetically inactivated Ezh2 in satellite cells of laboratory mice, the mice failed to repair muscle damage caused by traumatic injury — satellite cells could not proliferate.

Ezh2 expression is known to decline during aging, and the new research in mice suggests that therapies to activate Ezh2 and promote satellite cell proliferation might eventually play a role in treating degenerative muscle diseases.

“We will not be able to cure the muscular dystrophies with this approach because the mutation in the gene that causes the diseases would remain. But certainly, if we can extend the period in which the satellite cells proliferate and compensate for the underlying defect, we might increase the lifespan of people with muscular dystrophy. We could certainly increase their quality of life,” said Dr. Sartorelli.

Likewise, in the elderly, tweaking the gene in satellite cells would not increase their lifespan, but could increase their quality of life by helping to prevent falls and enabling them to move and walk better and go about their daily activities.

Dr. Sartorelli cautions that while the identification of Ezh2’s role is a crucial step, any therapies are still many years away.

Source: NIH

Lymphoma Risk From TNF Blockers in Teens, Says FDA

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The U.S. Food and Drug Administration (FDA) continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.

Crohn’s disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, weight loss, joint pain, skin problems and fever also may occur. Children with the disease may have growth problems, develop intestinal blockage, and experience malnutrition. [Read more…]

Complementary and Alternative Medicine: Patients Don’t Tell Their Doc’s

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Despite their high use of complementary and alternative medicine (CAM), Americans over the age of 50 often do not discuss CAM use with their health care providers, a survey indicates.

The results, from AARP and the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health were released today.

Overall, 53 percent of respondents reported that they had used CAM at some point in their lives. Among those, 58 percent said they had discussed CAM with a health care provider.

This dialogue is important because, while CAM is a part of health and wellness for many Americans, some CAM products can interact with conventional medicine.

CAM is a group of diverse medical and health care interventions, practices, products, or disciplines that are not generally considered part of conventional medicine. CAM includes natural products such as herbal supplements, and manual therapies and mind/body practices such as chiropractic care, massage, acupuncture, and meditation.

Use of CAM among the 50 and older population is widespread. The 2007 National Health Interview Survey found that 44 percent of people aged 50-59 use some form of CAM, compared to the average adult use rate of 38 percent.

“Older Americans want to lead healthy, active lives, and that means using health care safely,” said AARP Vice President Elinor Ginzler. “For many people, CAM is an important part of staying healthy, but some CAM products may make conventional medicines less effective or lead to potentially dangerous interactions. Health care providers and patients need to start talking together to ensure you get the full benefit of both CAM and your medications.”

Other findings from the AARP/NCCAM survey suggest that if CAM is discussed at a medical appointment, it is most likely to be brought up by the patient. Respondents were twice as likely to say they raised the topic rather than their health care provider. According to the survey, the two main reasons that the patients gave for a lack of discussion with their health care providers are that the provider never asks (42 percent) and the patients did not know they should bring it up (30 percent).

In the survey, the most frequently cited reasons for using CAM are for general wellness (77 percent), to help reduce pain or treat a painful condition (73 percent), to treat a specific health condition (59 percent), and to supplement conventional medicine (53 percent). Those surveyed could provide more than one reason for using CAM.

“In this survey, we found that 37 percent of respondents have used an herbal product or dietary supplement in the past 12 months. Some of these natural products can interact with conventional treatments,” said Josephine P. Briggs, M.D., director of NCCAM. “As we’ve learned from NCCAM-funded research into herbal and dietary supplements, natural does not always mean safe. Thus, an open dialogue about CAM use, particularly herbals and dietary supplements, is vital to ensuring safe and coordinated care.”

The AARP/NCCAM survey was conducted by telephone interview in October 2010, with a random sample of 1,013 people aged 50 and older.

Source: NIH

Dengue Fever Diagnostic Test Approved for Marketing

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The U.S. Food and Drug Administration (FDA) today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.

The dengue virus is transmitted to humans by the bite of an infected Aedes mosquito. As many as 100 million people worldwide are infected by the virus each year, according to the U.S. Centers for Disease Control and Prevention (CDC).

Symptoms of dengue fever include high fever, severe headache, severe pain behind the eyes, joint pain, muscle and bone pain, rash and mild bleeding involving the nose or gums, and easy bruising. [Read more…]

Antimicrobial Resistance a Growing Health Threat, Says CDC

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Millions of Americans take antimicrobial drugs each year to fight illness, trusting they will work. However, the bacteria, viruses and other pathogens are fighting back.

Within the past couple of years alone, new drug-resistant patterns have emerged and resistance has increased – a trend that demands urgent action to preserve the last lines of defense against many of these germs.

Today, the Centers for Disease Control (CDC) joined the World Health Organization and other health partners in recognizing World Health Day, which this year spotlights antimicrobial resistance. [Read more…]

U.S. Cancer Rates Decline

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Rates of death in the United States from all cancers for men and women continued to decline between 2003 and 2007, the most recent reporting period available, according to the latest Annual Report to the Nation on the Status of Cancer. The report also finds that the overall rate of new cancer diagnoses for men and women combined decreased an average of slightly less than 1 percent per year for the same period.

The drop in cancer death rates continues a trend that began in the early 1990s. The report finds, for the first time, lung cancer death rates decreased in women, more than a decade after rates began dropping in men. [Read more…]

Company Recalls Hazelnuts Linked to E. Coli

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DeFranco & Sons of Los Angeles, Calif. is voluntarily recalling bulk and consumer-packaged in-shell hazelnuts and mixed-nut products containing in-shell hazelnuts. The recalled products are linked to seven cases of Escherichia coli O157:H7 in Michigan, Minnesota and Wisconsin and may cause serious illness.

Consumers who have purchased bulk in-shell hazelnuts or mixed-nut products containing in-shell hazelnuts should check with the retailer to determine if they are subject to the recall, or throw the nuts away. [Read more…]

Epilepsy Drug Topiramate May Increase Birth Defect Risk

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New data suggest that the drug Topamax and its generic versions (topiramate) increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration (FDA) said today.

Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Alternative medications that have a lower risk of birth defects should be considered.”

[Read more…]

Hypertension Drug Letairis Gets New Boxed Warning: No Monthly Liver Enyme Test Required

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Monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), according to the U.S. Food and Drug Administration (FDA). The drug is used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and post-market reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug’s boxed warning. [Read more…]