On Thursday, the panel voted 16 to 0 to recommend approval of the imaging agent, known as Amyvid, with one critical caveat: Manufacturer Eli Lilly and Co. must demonstrate that standards for interpreting brain scans that show amyloid plaques illuminated by Amyvid can be made consistent enough to routinely guarantee an accurate diagnosis.
Amyvid (florbetapir) is injected into patients who then undergo a PET scan; a negative result can help rule out Alzheimer's, according to Lilly.
Experts agreed that the test could become a critical part of spotting Alzheimer's before symptoms have taken hold, but they noted that the clinical reality of that is far from imminent.
"It may well be that amyloid imaging will join colonoscopy, mammography, etc. as mid-life surveillance tests, and that anti-amyloid interventions are most effective in the pre-symptomatic stages of Alzheimer's disease," said Dr. Sam Gandy, the Mount Sinai Chair in Alzheimer's Disease Research in New York City. However, this possibility is years away, he added.
The value for research is clear, Gandy said. "Either a spinal fluid amyloid test or an amyloid scan will help weed out non-Alzheimer's dementias in clinical trials of anti-amyloid agents. The clinical value in the short-term is less obvious."
Current medications are most effective in the early stages of Alzheimer's, and amyloid scans might identify those patients for doctors who don't have access to neuropsychological testing, Gandy said.
"A confirmed diagnosis would enable planning for the future while patients are at an early enough stage to still participate in the discussion," he said. "In the symptomatic patient, the amyloid scan would portend the onset of dementia within the next five years."
However, because there is no cure for Alzheimer's disease yet, the test might be one that is not considered worth its cost, Gandy said.
Gandy noted that the "300-pound gorilla in the room" is whether Medicare/Medicaid will reimburse such a test, even if the FDA follows its expert panel's advice and approves Amyvid. (While the FDA doesn't have to follow a panel's advice, it usually does.) "Medicare may decide that the added value does not merit reimbursement without a meaningful intervention," he said.
Also, Grandy said he doesn't expect approval until there are methods in place to train doctors in how to read these scans.
Another expert, David Loewenstein, a professor of psychiatry and behavioral sciences and neurology at the University of Miami Miller School of Medicine, said that the approval of Amyvid "will allow physicians to come to an earlier diagnosis of Alzheimer's."
What is needed is consistency for evaluating scans using the agent, he said, so that physicians "can apply a single standard and there won't be gaps between hospitals because of different readers using different methods."
Loewenstein thinks use of this new diagnostic tool will help in several ways. First, it will help researchers find effective treatments by diagnosing the disease early, although having the plaques does not always mean the patient has Alzheimer's. Second, it will identify people who can take part in clinical trials of new Alzheimer's drugs.
"There is a whole new line of drugs being formulated that will help treat the earliest stages of the disease," Loewenstein said. "We need to know who are the appropriate people with the mildest cognitive problems to get into clinical trials."
In addition, the test has value even before treatments are available in terms of helping patients prepare for the course of the disease, Loewenstein noted. "I think many people would like an early diagnosis," he said.
For more information on Alzheimer's disease, visit the Alzheimer's Association.
The report, titled "Influence of Resistance Exercise on Lean Body Mass in Aging Adults: A Meta-Analysis," was published in Medicine & Science in Sports & Exercise®, the official scientific journal of the American College of Sports Medicine. A research team with the University of Michigan compiled data from 49 studies to assemble this report. They found that older adults gain an average of 2.42 pounds of lean body mass, primarily muscle, after strength training for approximately 20 weeks.
This 2.42-pound increase counteracts the 0.4 pounds of muscle lost each year by sedentary adults over age 50. The findings suggest that aging individuals should consider beginning a strength training regimen as early as possible to maximize results and delay sarcopenia, an age-related muscle deterioration that can lead to mobility disability and loss of independence for seniors.
"The findings of this analysis are significant, given the millions of U.S. adults affected by sarcopenia," said Mark Peterson, Ph.D., lead author of the study. "Because we have identified a robust link between resistance exercise and lean body mass, future generations of seniors who incorporate this modality may be less affected by age-related muscle loss and better able to preserve independence and quality of life."
In addition to beginning a strength training program early in life, researchers also recommend adults consider the volume, or number of sets, of their program. The analysis suggests progression models, with gradual changes in volume and load, are appropriate to accommodate long-term growth in muscle mass.
"Our report is the first comprehensive meta-analysis to confirm a significant association between strength training volume and lean body mass increases in aging men and women," said Dr. Peterson. "These findings suggest that, while effective for getting started, a single set of resistance exercises and/or fixed-volume programs may no longer be sufficient for individuals looking to achieve long-term changes in lean body mass."
Researchers screened more than 5,000 references for this analysis, and 49 studies with 81 cohorts were selected for inclusion based on several criteria. The selected studies had an average participant age of at least 50 years, incorporated supervised, whole-body resistance training programs, and lasted at least eight weeks in duration.
ACSM and the Physical Activity Guidelines for Americans recommend that adults get at least 150 minutes of moderately intense physical activity each week. For more information on exercise for older adults, see the ACSM Position Stand on "Exercise and Physical Activity for Older Adults."
Source: American College of Sports Medicine
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Currently, there is no cure for Alzheimer's. But drug and non-drug treatments may help with both cognitive and behavioral symptoms.
Researchers are looking for new treatments to alter the course of the disease and improve the quality of life for people with dementia.
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THE AID & ATTENDANCE PENSION
The Aid and Attendance (A&A) Pension provides benefits for veterans and surviving spouses who require the regular attendance of another person to assist in eating, bathing, dressing and undressing or taking care of the needs of nature. It also includes individuals who are blind or a patient in a nursing home because of mental or physical incapacity. Assisted care in an assisting living facility also qualifies.
To qualify for A&A it needs to be established by your physician that you require daily assistance by others to dress, undress, bathing, cooking, eating, taking on or off of prosthetics, leave home etc. You DO NOT have to require assistance with all of these. There simply needs to be adequate medical evidence that you cannot function completely on your own.
The A&A Pension can provide up to $1,632 per month to a veteran, $1,055 per month to a surviving spouse, or $1,949 per month to a couple*.
Eligibility must be proven by filing the proper Veterans Application for Pension or Compensation. (Form 21-534 surviving spouse) (Form 21-526 Veteran.) This application will require a copy of DD-214 (see below for more information) or separation papers, Medical Evaluation from a physician, current medical issues, net worth limitations, and net income, along with out-of-pocket Medical Expenses.
A DD-214 is issued to military members upon separation from active service. DD-214s were issued to separated service members beginning in the 1950's. The term "DD-214" is often used generically to mean "separation papers" or "discharge papers", no matter what form number was used to document active duty military service. If the VA has a copy of a DD-214, it is usually because the veteran attached a copy (or sometimes, the original) to his or her application for disability or education benefits. If you've lost your original DD-214 or a copy and you are receiving (or applied for in the past) disability or education benefits from the VA, they may have a copy (or the original, if you gave it to them) on file. At the very least, if you are currently receiving benefits (or did in the past), they should be able to provide a Statement of Service, which can be used instead of a "DD-214".
To request a copy of a DD-214 visit www.vetrec.archives.gov.
For more general information about the Aid & Attendance Pension, please see our FAQ Section.
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