From: hounddog23x@gmail.com   
      
   The Washington Post   
   Social Issues   
      
   FDA approves tool for diagnosing dementia in a doctor's office   
      
      
   Correction: An earlier version of this article misspelled the name of the   
   person who designed the MMSE test. This version has been corrected.   
      
   By Fredrick Kunkle August 10     
      
      
   A small company started by a neuroscientist at the University of Rochester has   
   moved closer to providing doctors with what he says is a simple,   
   computer-based tool to help detect early signs of Alzheimer's disease or other   
   forms of dementia.   
      
   Cerebral Assessment Systems has received marketing approval from the U.S. Food   
   and Drug Administration for Cognivue, a cognitive-assessment tool that   
   functions somewhat like a video game. A patient can perform the inexpensive   
   and simple test while a time-   
   strapped primary-care physician tends to other patients. The 10-minute,   
   non-invasive examination can detect subtle lapses in the brain's perceptual   
   ability that may signal the early stages of mental decline caused by dementia.   
      
   The federal government's approval to market the device comes as Alzheimer's   
   researchers everywhere step up the pursuit for easier and more inexpensive   
   ways to identify dementia in its earliest stages.   
      
   [Scientists are cautiously optimistic about progress toward finding treatments   
   for Alzheimer's disease]   
      
   "Look, there is a late-life tsunami of late-life cognitive decline coming at   
   us, and health-care providers are standing on the beach," said Charles J.   
   Duffy, a neurology professor at the University of Rochester Medical Center who   
   founded the company. "   
   What we are all about is making cognitive care part of primary care."   
      
   More than 5 million Americans have Alzheimer's disease, the leading cause of   
   dementia. That number is expected to reach 13.5 million by 2050, according to   
   the Alzheimer's Association. With the United States shifting toward an older   
   society, the hope is    
   that earlier detection can lead to earlier intervention to slow or arrest the   
   disease, perhaps through medications working their way to the market or   
   changes in lifestyle. In addition to Alzheimer's, a person's mental competency   
   can be hindered by other    
   conditions, such as untreated diabetes, thyroid conditions or toxic   
   interactions among prescription medications.   
      
   Duffy said his tool holds promise as a relatively inexpensive and easy way to   
   test people's memory and ability to think.   
      
      
   With Cognivue, patients sit before a video screen that shows a series of   
   images, such as a group of dots, that move around and fluctuate in clarity.   
   Using a rotary-shaped mouse called a manipulandum, the patients try to follow   
   the dots with a wedge-   
   shaped cursor. The task becomes more difficult, especially for people with   
   early stages of dementia, as the dots move around, changing their direction,   
   speed and intensity.   
      
   "All perception is interpretive, and so what we're doing is measuring that   
   process," Duffy said. Other parts of the test challenge memory recall or the   
   ability to recognize letters and shapes.   
      
   Cerebral Assessment Systems' device received de novo approval from the FDA, a   
   streamlined process for reviewing medical devices that appear to be new enough   
   to have no equivalent and pose little risk.   
      
   The Pittsford, N.Y.-based company's FDA application included data from a   
   comparative study involving 401 people recruited from 13 communities for older   
   adults. The subjects, ranging in age from 55 to 95, were classified in three   
   groups based on cognitive    
   abilities: normal, mild cognitive impairment and impaired. Their performance   
   on the Cognivue device was compared to their scores on an existing cognitive   
   assessment test known as the St. Louis University Mental Status Examination   
   (SLUMS).   
      
   The device would be available only for use by medical professionals as part of   
   a more comprehensive assessment of cognitive function. It is not intended to   
   be a standalone diagnostic tool, and its effectiveness for people with less   
   than 12 years of    
   education is not proven.   
      
   Linda M. Rice, a primary-care internist with about 1,200 patients in her   
   Rochester practice, said that after a year of using the device in her clinic,   
   she is convinced of its worth. About half of her patients are older than 65,   
   and they often have    
   questions about memory loss and their cognitive abilities.   
      
   But her options for rating their performance involve administering the   
   Mini-Mental State Exam (MMSE) , also known as the Folstein test, that uses a   
   30-point questionnaire. The test, which has been around since 1975, offers   
   only a broad indication of    
   cognitive abilities and fails to pick up borderline problems, she said.   
      
      
   "You have to be pretty bad to do poorly on this exam," she said.   
      
   But the alternative involves referring patients for a battery of   
   neuropsychiatric tests that can take hours to complete and cost $1,000 or   
   more. The computer-based tool created by Duffy has helped Rice to convince   
   some patients that it's time to stop    
   driving and to start them on medications sooner to slow the progress of   
   Alzheimer's.   
      
   "I think it's a really potentially valuable tool," said Leslie Algase, an   
   internist who tends about 2,000 patients in Rochester, at least 30 percent of   
   whom are older than 65. Algase, who said she has no financial ties to the   
   company, agreed to use the    
   Cognivue in her practice about three years ago after meeting Duffy at a   
   conference.   
      
   Algase rates the device as about as accurate as the MMSE. But she said it's   
   more convenient and less time-consuming to administer.   
      
   http://www.washingtonpost.com/local/social-issues/fda-approves-m   
   rketing-of-convenient-tool-to-diagnose-dementia/2015/08/10/fe346   
   9e-3d47-11e5-9c2d-ed991d848c48_story.html   
      
   --- SoupGate-Win32 v1.05   
    * Origin: you cannot sedate... all the things you hate (1:229/2)