Vancouver, Canada — With FDA approval of a brain amyloid imaging compound in early 2012 and the expected start in 2012 and 2013 of three clinical trials in people with pre-symptomatic Alzheimer’s disease, issues around disclosure of dementia risk status are becoming more urgent. Several research efforts have been reported at the Alzheimer’s Association International Conference describing the creation and evaluation of new risk disclosure methods, and the examination of related ethical issues.

Alzheimer’s is a devastating, progressive, and fatal illness. There is a movement in the Alzheimer’s research field to detect and treat the disease earlier – even before there are outward symptoms – so that people do not have to suffer from the debilitating memory and thinking problems that lead to loss of normal daily activities and independence, and eventually death.

A number of Alzheimer’s prevention trials are in the planning stages. They will be conducted in people without memory or thinking symptoms who are considered at-risk for Alzheimer’s on the basis of genetic and/or biomarker positivity.

A biomarker is something in the body that can be measured as an indicator of normal biological processes, disease processes, or changes in response to therapy. For example, cholesterol levels are a biomarker for heart disease. A variety of imaging and fluid biomarkers are under investigation in Alzheimer’s disease. Biomarkers allow investigators and clinicians to detect Alzheimer’s-related changes in the brain and other body systems prior to the onset of dementia symptoms due to Alzheimer’s.

“Biomarkers are being increasingly used in clinical practice and research trials to provide risk information for Alzheimer’s. The goal is to develop evidence-based methods for communicating this risk in effective and supportive ways,” said J. Scott Roberts, Ph.D., of the University of Michigan, School of Public Health. Dr. Roberts is chair of an AAIC 2012 featured research session where new research on disclosing risk information will be reported and discussed.

One of the most promising biomarkers is brain imaging using positron emission tomography (PET) scans that can show whether a person has deposits of an abnormal protein called beta amyloid, which is one of the hallmarks of Alzheimer’s disease. There also are well-established genetic risk factors, such as the APOE Alzheimer’s risk gene.

Based on current knowledge, APOE-e4 is the gene with strongest impact on Alzheimer’s risk. APOE-e4 is one of three forms of the APOE gene; the others are APOE-e2 and APOE-e3. Everyone inherits a copy of APOE from each parent. Those who inherit one copy of APOE-e4 have an increased risk of developing Alzheimer’s. Those who inherit two copies have an even higher risk, but not a certainty. Scientists estimate that APOE-e4 is implicated in about 20 to 25 percent of Alzheimer’s cases. APOE-e2 may provide some protection against Alzheimer’s.

Until recently, the presence of brain amyloid could only be confirmed by autopsy. Now it is possible to look for the protein in living brains using a special type of dye during a PET scan. These PET scans may help determine whether or not a person who is experiencing memory loss has Alzheimer’s disease.

“People with memory loss who test negative on a PET scan using the newly-approved dye do not have Alzheimer’s disease,” said William Thies, Ph.D., Alzheimer’s Association Chief Medical and Scientific Officer. “Their symptoms are caused by something else. If they test positive, the cause is likely Alzheimer’s, but that is not 100% certain because the presence of amyloid can be detected in other diseases besides Alzheimer’s. We do not yet know what the test means in people without symptoms. The predictive value of the test is uncertain.”

“The disclosure of test results to cognitively normal older people raises some important ethical issues because researchers and clinicians do not yet know how to interpret them. How will this biomarker information be gathered? When, how, and to whom will it be disclosed? How do we disclose it accurately while minimizing any potential negative impact? These are issues that must be addressed by the research and healthcare communities, with crucial input from Alzheimer’s families and other stakeholders,” Thies added.

The Alzheimer’s Association currently is working with the Society of Nuclear Medicine to develop guidelines for when an amyloid PET scan is appropriate and how it should be interpreted.

Disclosing Alzheimer’s disease genetic risk to people with MCI

The Risk Evaluation and Education for Alzheimer’s Disease Study (REVEAL) is a multi-center randomized clinical trial enrolling people with mild cognitive impairment (MCI) to investigate the impact of disclosing “imminent” Alzheimer’s disease risk information – specifically, the probability of progressing to Alzheimer’s within the next three years. The trial tests different methods for disclosing this information, including a method where genetic testing is used to refine the risk estimates given to study participants.

“We hope to learn how people with MCI and their study partners respond to health education and learning risk information,” said Robert C. Green, M.D., MPH, of Brigham and Women’s Hospital and Harvard Medical School. “We continue to evaluate how well participants understand the Alzheimer’s risk assessment and what they do with the information. We’re monitoring how the people with MCI and their care partners adjust psychologically and what health related and behavioral changes they make in response to the new information.”

Green and colleagues designed and are implementing an evidence-based procedure for risk estimation and an experimental trial of APOE genotype disclosure in people age 55 to 90 with MCI and their study partners recruited at four university medical centers (Harvard, Univ. of Michigan, Univ. of Pennsylvania, and Howard). Participants receive risk estimates for their chance of progressing to Alzheimer’s disease that are based on their age, MCI diagnosis and APOE genotype (intervention arm) or age and MCI diagnosis alone (control arm). Risks disclosed to participants range from 8-57% in the intervention arm and 25-44% in the control arm.

The research team developed graphics and language to facilitate communication of APOE genotype and numerical risk estimate. Both participants with MCI and their study partners are followed up to 6 months following risk disclosure to determine its impact on caregiver distress, health behavior, and insurance/lifestyle changes. To inform further development of educational materials, researchers will also evaluate how well participants understood the information that was provided to them.

“This is the first study to examine the impact of disclosing Alzheimer’s genetic risk information to individuals with MCI,” Green said. “We believe the findings from REVEAL will have important implications for clinicians and policy makers in informing the future practice of educating and treating people at risk for Alzheimer’s.”

Disclosing brain amyloid imaging results to people with MCI and their families

Brain amyloid imaging is increasingly recognized as a powerful tool for predicting whether people with MCI will transition to Alzheimer’s disease.  As this technology moves from the research setting into clinical practice, an emerging concern is that people with MCI may have difficulty comprehending their test results.

Given the lack of research on disclosing this information to people with cognitive impairments, Jennifer Lingler, Ph.D., of the University of Pittsburgh, Pennsylvania, and colleagues conducted a study to develop a standardized procedure for effectively communicating amyloid imaging results in the context of MCI, which is often described as an intermediate state between normal cognitive aging and Alzheimer’s.

Based on previous research and insights from a panel of experts in neuroimaging, neuropsychology, risk communication, regulatory affairs, and bioethics, Lingler developed scripts and visual aids that guide clinical researchers in disclosing positive, negative, or inconclusive amyloid scan results. Ten people with MCI and 10 of their family members participated in mock results disclosure sessions and provided feedback on the procedure.

The researchers found that:

• The great majority of participants reported that the session was “easy to follow,” (19 of 20) “included just about the right level of detail,” (17 of 20) and was “just about right” in length (17 of 20).
• All 20 participants rated the information as “clearly presented.”
• Eight of the 10 family members and seven of the 10 people with MCI correctly repeated their mock results back to an interviewer after the session.
• Analysis of interview data from the five participants with questionable comprehension suggested that (a) cognitive factors may explain problems with comprehension among those with MCI, while (b) emotional factors may underlie problems with comprehension among family members.

“Our study demonstrates that it is possible to provide people with MCI and family members with highly comprehensible and acceptable information about their brain imaging results of Alzheimer’s risk,” Lingler said. “However, since some of the participants had some difficulty, we recommend that a family member or friend be present, and that emotional support be provided, when imaging results are discussed.”

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Vancouver, Canada — Anavex Life Sciences Corp. (“Anavex”) announced on July 9 that new data on ANAVEX 2-73, the company’s lead compound for Alzheimer’s disease currently in human clinical trials, will be presented in a poster session at the 2012 Alzheimer’s Association International Conference (AAIC) in Vancouver, BC, Canada.

The ANAVEX 2-73 poster will be presented by Tangui Maurice, PhD, CNRS Research Director, Team II Endogenous Neuroprotection in Neurodegenerative Diseases INSERM, University of Montpellier. The presentation will be held on Monday, July 16 from 1 PM- 3:30 PM. The title of the presentation will be: ”Neuroprotective efficacy of ANAVEX 2-73, a novel tetrahydrofuran derivative targeting the sigma-1 chaperone protein, in a mouse model of Alzheimer’s disease: Analyses of administration schedules and combination studies with donepezil and memantine.”

AAIC 2012 takes place Saturday, July 14 to Thursday, July 19, 2012 in Vancouver. It is the world’s premiere forum for reporting and discussion of groundbreaking research and information on the cause, diagnosis, treatment and prevention of Alzheimer’s disease and related disorders. The conference website boasts that AAIC 2012 will “join the world’s leading dementia scientists to share the latest thoughts and theories in the field – and spark new ideas along the way.” Additional information about the conference is available at http://www.alz.org/aaic/.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (www.anavex.com) is a pharmaceutical company engaged in the development of novel drug candidates. Anavex utilizes its proprietary SIGMACEPTOR Platform to develop drug candidates targeting specific clinical indications. Lead compound ANAVEX 2-73, developed to treat Alzheimer’s through disease modification, is in human clinical trials.

A Phase 1 single ascending dose study of ANAVEX 2-73 was successfully completed in Germany in 2011. Studies indicate that ANAVEX 2-73 demonstrates anti-amnesic and neuroprotective properties, and that it is well tolerated in doses up to 55mg. The company is preparing to embark on a multiple ascending dose clinical trial of ANAVEX 2-73 in 2012. Anavex is a publicly traded corporation quoted as AVXL.

Image Courtesy of   Argonne National Laboratory

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Simple tests such as walking speed and hand grip strength may help doctors determine how likely it is a middle-aged person will develop dementia or stroke. That’s according to new research that was released on February 15, and will be presented at the American Academy of Neurology’s 64th Annual Meeting in New Orleans April 21 to April 28, 2012.

“These are basic office tests which can provide insight into risk of dementia and stroke and can be easily performed by a neurologist or general practitioner,” said Erica C. Camargo, MD, MSc, PhD, with Boston Medical Center.

More than 2,400 men and women with an average age of 62 underwent tests for walking speed, hand grip strength and cognitive function. Brain scans were also performed.  During the follow-up period of up to 11 years, 34 people developed dementia and 70 people had a stroke.

The study found people with a slower walking speed in middle age were one-and-a-half times more likely to develop dementia compared to people with faster walking speed.  Stronger hand grip strength was associated with a 42 percent lower risk of stroke or transient ischemic attack (TIA) in people over age 65 compared to those with weaker hand grip strength.  This was not the case, however, for people in the study under age 65.

“While frailty and lower physical performance in elderly people have been associated with an increased risk of dementia, we weren’t sure until now how it impacted people of middle age,” said Camargo.

Researchers also found that slower walking speed was associated with lower total cerebral brain volume and poorer performance on memory, language and decision-making tests.  Stronger hand grip strength was associated with larger total cerebral brain volume as well as better performance on cognitive tests asking people to identify similarities among objects.

“Further research is needed to understand why this is happening and whether preclinical disease could cause slow walking and decreased strength,” said Camargo. Learn more about dementia and stroke at http://www.aan.com/patients.

The study was supported by the National Heart, Lung and Blood Institute’s Framingham Heart Study and by the National Institute of Neurological Disorders and Stroke and the National Institute on Aging.

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“It’s a national disgrace that so many families dump their elderly parents in nursing homes and assisted living facilities. We need to become a nation of family caregivers. Sons and daughters should invite their aging and aged mothers and dads to live with them,” says trends analyst and forecaster, and family caregiver, Stephen L. Goldstein, Ph.D.

“Yes, you can!” Goldstein reassures families in his memoir/how-to, When My Mother No Longer Knew My Name: a son’s “course” in “rational” caregiving. It could be titled “the joy of caregiving!” It’s the first book families need to read, the caregiver’s “one-minute manager.” Each brief, compelling chapter turns what a son learned on-the-job into immediate help for others. Step-by-step, Goldstein traces how his caregiving role evolved from nominal to 24/7.

“I would never let my mother live in a nursing home,” he says adamantly. “Diplomatically, I had to convince her to move in with me when she was strong and healthy. Eventually, I learned how to deal with her dementia—finding a sandwich in the clothes dryer, changing her diaper (rarely, thank God!), keeping her from choking to death. Finally, I had to discover how to care for myself after she died.

“I wrote the book I never found before and while I was my mother’s caregiver,” Goldstein says. “There’s no theory. Strategically placed throughout the book are 75 practical tips that turn my experience into advice others can use. My narratives make caregiving real. My tips make it manageable—even joyful.” There’s a “Self-Assessment” so current and potential caregivers can benchmark and increase their ability to manage the often lonely, challenging, unpredictable, and overwhelming roles they may assume.

When My Mother No Longer Knew My Name is a one-man support group, written like a friend who’s “been-there-done-that,” talking anecdotally, but authoritatively, to a friend who needs help. It’s raw and gritty, funny and inspiring. It makes people weep, but also gives them hope they can overcome a mountain of seemingly insurmountable challenges, for which they likely feel devastatingly unprepared.

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Yesterdays (Wednesday, June 6) death of former Baltimore Colt and hall of fame tight-end John Mackey, exhibits how much of a necessity fines and suspensions are for helmet-to-helmet hits.

Mackey died Wednesday from dementia, which has been linked to people who suffer concussions. Dementia is defined as, “ a loss of brain function that occurs with certain diseases. It affects memory, thinking, language, judgment, and behavior.”

Despite mounting evidence that NFL players who experience concussions are at risk to dementia, football players themselves have not been swayed to the idea that fines and suspensions for helmet-to-helmet hits are the right step forward. NFL players are hypocritical when it comes to their own safety; they want to have their cake and eat it to.  A majority of players don’t want to be fined or suspended for a helmet-to-helmet hit yet they are fighting for better health benefits.

There are countless examples of players saying they want to injure opposing players. This past year James Harrison of the Steelers was a perfect example. Following a game in which he hit Browns wide receiver Josh Cribbs with a helmet-to-helmet collision, Harrison spoke of having the intent to hurt people on the football field yet not injure them. Harrison stated, “I don’t want to injure anybody. There’s a big difference between being hurt and being injured. You get hurt, you shake it off and come back the next series or the next game. I try to hurt people.”

Its comments like Harrison’s that make the current NFL policy of fining players and suspending them after such types of collisions a necessity. Linebacker Channing Crowder, of the Miami Dolphins, said this past NFL season, “They give me a helmet. I’m going to use it.”

There’s an unmistakable difference between players’ helmets accidentally colliding and when they are used as weapons to tackle the opponent. Wide receiver of the San Diego Chargers, Patrick Crayton puts this difference in crystal clear fashion saying, “When you come in to tackle, sometimes helmets collide. But when a guy’s suspended in the air, and you launch yourself at his head, come on now. You can tell because usually their hands go down and it’s just a straight line to the head, a missile almost.”

Clearly, as Crayton points out, there is a difference between accidental helmet-to-helmet contact and the blatant use of a helmet as a purposeful weapon to tackle and seriously hurt opponents.  Helmet to helmet contact, according to some like Yeremiah Bell, say that it’s something “which guys aren’t trying to do, but that’s just the way it is. It’s part of the game.”

Players also say that the rules in place that fine and suspend players for unintentional and intentional helmet-to-helmet hits will change the game in negative ways.  Linebacker Ray Lewis, of the Baltimore Ravens, comments, “My opinion is play the game like that game is supposed to be played, and whatever happens, happens. If you go into the game thinking about any of that stuff, I’m telling you, the game will be diluted very quickly.”

A similar sentiment is shared by New York Giants safety Antrel Rolle, who warns,  “This is a game of physical guys going to battle. Once you start saying to guys ‘You’ll get suspended for a game,’ that’s when you’re going to get a very, very tentative football game.”

However, these injuries like the one sustained by John Mackey, which led to his death from dementia, are more important than keeping the game the way that it is now. It’s not worth it for player’s lives to be put at risk in the short term, or the long term. The sad truth is, players’ like Mackey who suffer from dementia suffer severe side affects. More specifically, as an example, Matt Crossman of sportingnews.com shares, former Chicago Bear Larry Morris, who suffers from dementia “can’t sign his name, can’t complete basic hygiene tasks and sometimes struggles to dress himself.”

During the short term players get very good health benefits from the NFL. However, if a player is retired they get terrible health benefits. Recently, Ravens cornerback Domonique Foxworth and senior writer Peter King of Sports Illustrated wrote an article for King’s, Monday Morning Quarterback column.

In the article, King and Foxworth paint a vivid picture of what retired players are going through, saying, “Players who retire from the NFL leave with, at most, five years of health insurance, but often with several lifetimes worth of injuries and recurring mental health issues. Elvin Bethea, the Hall of Fame defensive end for the former Houston Oilers, for example, has had over 25 operations relating to his football career and racked up astronomical medical bills, all without the pension support.”

Better health benefits for retired players are one of the caveats players are fighting for during the current lockout that has been taking place.  In reference to what plays are currently fighting for Foxworth, says, “we are fighting for things you’re more likely to find in a game of LIFE: a safer practice regimen, better pensions for former players, long-term health insurance.” Foxworth elaborates saying that it is essential to fight for these benefits because of the “number of hits to the head” that players take, which “neuroscientists have come to consider as important long-term as in-game collisions.”

Foxworth, says, “Finding a way to guarantee that the players…receive adequate health insurance is not a nicety, it is a necessity”; it is also a necessity to have policies in place to limit the amount of future health problems for current players. Fines and suspensions for intentional helmet-to-helmet hits are important to the NFL, just like it should be for the NFL’s players.

If the NFL has to dish out expensive health benefits to every retired player who sustains a concussion or suffers from dementia they could potentially go bankrupt. The NFL is trying not only to save themselves from losses of money due to potential lawsuits in the future, but also, they are trying to limit the damage done to current players body’s hoping for less cases of dementia and other series life threatening injuries when they retire. Players should realize the NFL is trying to protect them as much as the NFL is trying to protect itself.

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