Mar 31, 2008

Lilly Launches Its First Phase III Trial for Treatment of Alzheimer's Disease

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Late-stage IDENTITY study of once-daily, oral agent is now enrolling
Eli Lilly and Company
(NYSE: LLY) has announced today the start of a Phase III clinical trial
studying LY450139, an investigational gamma secretase inhibitor for the
treatment of mild to moderate Alzheimer's disease.
Slowing the rate of disease progression could preserve independent
functioning and quality of life for Alzheimer's patients in the milder
stages of the disease, potentially delaying the onset of the severe stages
of the disease.
LY450139 is being tested
to see if it can slow the progression associated with Alzheimer's disease
by inhibiting gamma-secretase, an enzyme that can create a sticky protein
called amyloid beta.
IDENTITY is a randomized, double-blind, placebo-controlled trial that
will be conducted in the U.S. and 21 additional countries.
information regarding the IDENTITY trial, including global
recruitment sites, may be found at

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Vytorin Postgame: Worse Than Expected

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The discussion of that big Vytorin study at this weekend’s big cardiology meeting was harsher than expected. Industry observers had predicted that an open conversation by the experts could temper the negative image of the drug that emerged earlier this year after the study results were made public, but just the opposite occurred.
The study was presented at the conference yesterday and published online in the New England Journal of Medicine.
“You’ve just seen a negative trial that should change practice, especially the way we in this country have prescribed,” Harlan Krumholz of Yale told thousands of cardiologists at the meeting, the WSJ reports.
The NEJM also published an editorial based on the study results, calling on doctors to prescribe Zetia (and, by extension, Vytorin), only in selected cases.
Catherine Arnold of Credit Suisse called the discussion “surprisingly negative,”
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Mar 30, 2008

Alzheimer's Understand and control wandering

One of the questions I am most frequently asked is if I am worried that my mother might wander away from me and get lost. 

Wandering is one of the more widely known behaviors of people suffering from Alzheimer’s disease. This article from the Mayo Clinic explains this behavior and some of the likely causes and remedies.

Bob DeMarco
Alzheimer's Reading Room

Alzheimer's: Understand and control wandering

Find out why people with Alzheimer's wander and what you can do to keep them safe.

Alzheimer's disease can erase a person's memory of once-familiar surroundings and make adaptation to new surroundings extremely difficult. As a result, people with Alzheimer's sometimes wander away from their homes or care centers and turn up — frightened and disoriented — far from where they started, long after they disappeared.

With Alzheimer's, the Caregiver Is a Patient, Too

This is an interesting and thought provoking article that highlights the problems of Alzheimer's caregivers.

Caring for your Parents on PBS

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As the population ages, many adult children are grappling with an unprecedented social, cultural, economic, and personal revolution as they transition into the primary caregiver role for their aging parents. Produced, written, and directed by award-winning filmmaker Michael Kirk, Caring for Your Parents is a moving two-hour special that draws much-needed attention to this universal reality.

Image of father and son
The first 90-minutes of Caring for Your Parents underscores today's struggle to keep parents at home

Immediately after the 90-minute broadcast, medical correspondent Dr. Art Ulene leads "A Conversation About Caring." This half-hour panel discussion offers concrete advice and guidance on how to start the conversation‒often the most difficult step in caregiving.

Caring for Your Parents is a Kirk Documentary Group, Ltd. Production for WGBH Boston.
(check local listings)
Producer's Interview
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Mar 29, 2008

New Alzheimer's Disease Survey Reveals Children of Sandwich Caregivers Assist With Loved Ones' Care

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Three In Five Caregivers Say Their Children Help Care For Loved Ones With Alzheimer's Disease
Results from the third annual Alzheimer’s Foundation of America (AFA) ICAN: Investigating Caregivers’ Attitudes and Needs Survey suggest that Alzheimer’s disease care is a family affair. Most “sandwich caregivers” – the parents or guardians of children under 21 who also care for an aging parent, other relative or friend with Alzheimer’s disease – say their children are assisting with caregiving responsibilities that range from attending doctors’ appointments to feeding and dressing their loved ones.

Survey results released today found that about three in five caregivers say their children aged 8 to 21 are involved in caring for a loved one with Alzheimer’s disease. Of the caregivers who feel they do a good job balancing the care of their loved ones with Alzheimer’s disease and children under 21, more than one-third (36%) specifically cited support from children as a contributor to their success.

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PARADE Magazine Features Smart Genetics and Alzheimer's Mirror

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Magazine urges readers to participate in nationwide poll on Alzheimer's genetic testing
Smart Genetics has announced that PARADE magazine is featuring Alzheimer's Mirror as part of a nationwide poll asking readers if they want to learn their risk level for developing Alzheimer's disease. To vote, visit:
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Teva can't yet sell Alzheimer's generic (Aricept)

My mother takes Aricept at a cost of about $160 a month. A generic versions of Aricept is sure to benefit millions and dramatically cut the cost of health care.

We use to pay over $100 a month for Zocor. The generic now runs $10 a month (since July 2007).
Drug developer Teva Pharmaceutical Industries Ltd. said Friday a U.S. District Court ordered Teva to tentatively refrain from selling a generic version of Eisai Co.'s Alzheimer's treatment Aricept.
The tentative injunction by the U.S. District Court for the District of New Jersey was requested by Japan's Eisai as part of an ongoing lawsuit with Teva.
Teva has already gained tentative Food and and Drug Administration approval for the generic drug and could receive final approval April 26, when the mandatory stay of approval under the patent lawsuit expires. A trial date has not yet been set.
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How is Alzheimer's Disease Diagnosed?

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Today, the only definite way to diagnose AD is to find out whether there are plaques and tangles in brain tissue.
At specialized centers, doctors can diagnose AD correctly up to 90 percent of the time. Doctors use several tools to diagnose "probable" AD, including:
  • questions about the person's general health, past medical problems, and ability to carry out daily activities;
  • tests to measure memory, problem solving, attention, counting, and language;
  • medical tests - such as tests of blood, urine, or spinal fluid; and
  • brain scans.
  • Why is early diagnosis important?

    An early, accurate diagnosis of AD helps patients and their families plan for the future. It gives them time to discuss care options while the patient can still take part in making decisions. Early diagnosis also offers the best chance to treat the symptoms of the disease.

    The course the disease takes and how fast changes occur vary from person to person.
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    Free Online Publications Alzheimer's and Caregiving

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    National Institute on Aging Clinical Trials

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    The Alzheimer's Disease Clinical Trials Database is a joint project of the U.S. Food and Drug Administration (FDA) and the National Institute on Aging (NIA) maintained by the NIA's Alzheimer's Disease Education and Referral (ADEAR) Center.

    Here you can search a database of clinical trials on Alzheimer's disease and dementia currently in progress at sites throughout the U.S.:

    Search for Trials 
    Trials in the News 
    More Information:
  • AD Clinical Trials: Questions & Answers
  • To search further listings of clinical trials underway at the National Institutes of Health and other research institutions, go to
  • For information about submitting a clinical trial to the ADEAR database, send an e-mail to:
  • To receive updates about new clinical trials, subscribe to e-mail alerts.
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    Study Finds Improved Cognitive Health among Older Americans

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    Study Finds Improved Cognitive Health among Older Americans
    Rates of cognitive impairment among older Americans are on the decline, according to a new study supported by the National Institutes of Health (NIH) comparing the cognitive health of older people in 1993 and 2002. Higher levels of education were associated with better cognitive health.
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    What is Alzheimer's?

    Alzheimer's disease is a physical illness that causes radical changes in the brain. As healthy brain tissues degenerate persons suffering from Alzheimer's experience a steady decline in memory and the ability to use their brain to perform tasks.

    In order to be an effective Alzheimer's caregiver or to communicate with someone suffering from Alzheimer's disease, you must understand Alzheimer's disease. A solid understanding of Alzheimer's is an essential part of the foundation.

    Alzheimer's disease is the most common form of dementia.

    To continue reading and learn more about Alzheimer's disease go here.

    Mar 28, 2008

    Runaway health care costs — we’re #1!

    The latest Trustees’ reports from Social Security and Medicare show, once again, that there is no such thing as Socialsecuritymedicareandmedicaid. Social Security, the subject of thousands of demands that we get “serious” and cut benefits, is doing relatively well. The real problem lies in health care costs.

    I am, of course, a big proponent of health care reform. But is there any reason to think that reform would curb the growth of costs?

    Well, I was browsing some of the charts at CMS, and thought I’d share some information from Chart 2.1. This table shows health care spending as a percentage of GDP in some major countries, 35 years ago and recently:

    Everybody knows that the US spends much more on health care than anyone else
    What I didn’t realize was just how clearly the evidence shows that the rising trend is steepest in the US. We have the biggest increase as well as the highest level. We’re #1!
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    Early Research Suggests Umbilical Cord Blood Cell Therapy May Reduce Progression Of Alzheimer's Disease

    Stems cells derived
    from umbilical cord blood are showing early potential in fighting
    Alzheimer's disease, according to results from a new preclinical study
    published in the March issue of Stem Cells and Development
    conducted by researchers from the University of South Florida and Saneron
    CCEL Therapeutics, Inc
    ound that targeted immune suppression using stem
    cells derived from human umbilical cord blood reduced Alzheimer's disease
    progression in a mouse model
    The ongoing research project has been funded in part
    by Cryo-Cell International, Inc., an industry leader in stem cell
    innovation and one of the nation's largest and most established family cord
    blood banks. Additional study sponsors are the National Institutes of
    Health's STTR grant program, Florida High Tech Corridor Matching grant
    program, and the Johnnie B. Byrd, Sr. Alzheimer's Center and Research
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    Mar 27, 2008

    What is Visceral Fat?

    A recent article about belly fat and dementia is all over the news. The article refers specifically to "visceral fat" that surrounds the internal organs. This type of fat can be life threatening.

    My 91 year old mother suffers from Alzheimer's and has large deposits of visceral fat. This occurred late in her life and is due to bad eating habits and her loss of desire to move around or stay active.

    Mar 26, 2008

    Dementia Factsheet (Alzheimer's Disease)

    The section entitled, What are the Symptoms, is particularly interesting.Milton S Hershey Medical Center
    Subscribe to The Alzheimer's Reading Room--via Email

    Source Milton S Hershey Medical Center


    What is it?

    Dementia is the gradual deterioration of mental functioning, such as concentration, memory, and judgment, which affects a person’s ability to perform normal daily activities.

    Who gets it?

    Dementia occurs primarily in people who are over the age of 65, or in those with an injury or disease that affects brain function. While dementia is most commonly seen in the elderly, it is not a normal consequence of the aging process.

    What causes it?

    Dementia is caused by the death of brain cells. Brain cells can be destroyed by brain diseases, such as Alzheimer’s disease, or strokes (called vascular or multi-infarct dementia), which decrease blood flow to the brain. Lewy body dementia is another common cause attributed to changes in brain tissue. Other causes can include AIDS, high fever, dehydration, hydrocephalus, systemic lupus erythematosus, Lyme disease, long-term drug or alcohol abuse, vitamin deficiencies/poor nutrition, hypothyroidism or hypercalcemia, multiple sclerosis, brain tumor, or diseases such as Pick’s, Parkinson's, Creutzfeldt-Jakob, or Huntington's. Dementia can also result from a head injury that causes hemorrhaging in the brain or a reaction to a medication.

    What are the symptoms?

    In most cases, the symptoms of dementia occur gradually, over a period of years. Symptoms of dementia caused by injury or stroke occur more abruptly. Difficulties often begin with memory, progressing from simple forgetfulness to the inability to remember directions, recent events, and familiar faces and names. Other symptoms include difficulty with spoken communication, personality changes, problems with abstract thinking, poor personal hygiene, trouble sleeping, and poor judgment and decision making. Dementia is extremely frustrating for the patient, especially in the early stages when he or she is aware of the deficiencies it causes. People with dementia are likely to lash out at those around them, either out of frustration or because their difficulty with understanding makes them misinterpret the actions of others. They become extremely confused and anxious when in unfamiliar surroundings or with any change in routine. They may begin a task, such as cooking, then wander away aimlessly and completely forget what they had been doing. Dementia is often accompanied by depression and delirium, which is characterized by an inability to pay attention, fluctuating consciousness, hallucinations, paranoia, and delusions. People in advanced stages of dementia lose all control of bodily functions and are completely dependent upon others.

    How is it diagnosed?

    Dementia is diagnosed through a study of the patient’s medical history and a complete physical and neurological exam. The doctor will speak with those close to the patient to document a pattern of behavior. He or she will also evaluate the patient’s mental functioning with tests of mental status, such as those that require the patient to recall words, lists of objects, names of objects, and recent events. Diagnostic tests, such as blood tests, x-rays, or magnetic resonance imaging (MRI), positron emission tomography (PET), or computed tomography (CT) scans, can help determine the cause of the dementia.

    What is the treatment?

    In some instances, treating the cause of dementia may successfully reverse some or all of the symptoms. This is the case when the cause is related to a vitamin/nutritional deficiency, tumor, alcohol or drug abuse, reaction to a medication, or hormonal disorder. When dementia is related to an irreversible destruction of brain tissue, such as with Alzheimer’s disease, Lewy body dementia, or multiple strokes, treatment involves improving the patient’s quality of life as much as possible. This includes maintaining a stable, safe, supportive environment and providing constant supervision. While this may be done in the home, people in the advanced stages of dementia may require round-the-clock care in a long-term healthcare facility. It is important to provide the patient with structured activities and avoid disruptions to his or her daily routine. Many patients enjoy therapeutic activities, such as crafts or games, designed specifically for people with dementia. Some medications, such as donepezil and tacrine, have been effective in improving the mental functions of those in the beginning stages of dementia. Patients with hallucinations and delusions may also be treated with antipsychotic drugs, while antidepressant medications are used to treat depression.

    Self-care tips

    There is currently no known way to prevent dementia associated with Alzheimer's disease. You can decrease your risk of dementia associated with stroke by maintaining a healthy lifestyle, following a heart-healthy diet, and controlling high blood pressure and high cholesterol. Healthy lifestyles, including not smoking and not abusing drugs and alcohol, go a long way in keeping most people in good health. Caring for a person with dementia is stressful. It is important to learn all you can about the disease, seek the help of support groups, and find a responsible caregiver who can give you a break when needed. There are daycare programs specifically designed for patients with dementia that are good for the patient and the family.


    This information has been designed as a comprehensive and quick reference guide written by our health care reviewers. The health information written by our authors is intended to be a supplement to the care provided by your physician. It is not intended nor implied to be a substitute for professional medical advice.

    Read More about Alzheimer's disease

    The 36-Hour Day: A Family Guide to Caring for People with Alzheimer Disease and Memory Loss in Later Life

    Brain Health Improving in Seniors, But Alzheimer’s Still a Top Concern

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    Memory loss and thinking problems are becoming less common among older Americans, according to a new national survey of seniors aged 70 and older. Though preliminary, the findings correlate with other studies showing that overall, seniors today tend to be more physically fit and suffer from less disability than earlier generations. Still, with the population as a whole growing older, millions of Americans will continue to suffer from Alzheimer’s disease and related disorders in the coming years, making Alzheimer’s a top priority for this and future generations.
    the researchers, from the University of Michigan Health Center, found than over a 10-year period, from 1993 to 2002, the prevalence of mental impairment in seniors went down by 3.5 percentage points — from 12.2 percent to 8.7 percent, in a sample of some 11,000 people. The difference represents hundreds of thousands of people.
    seniors with more formal education and personal wealth were less likely to have cognitive problems
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    Big belly in middle age triples risk of dementia

    My mother has visceral fat. At her age it could be life threatening. There is no doubt this is a contributing factor to her Alzheimer's. She is exercising but at the age of 91, and after many years of bad eating habits, it is very difficult to get her to lose weight.

    Having a large belly in middle age nearly triples the risk of developing dementia.

    Researchers measured the abdominal fat of 6,583 people age 40 to 45 in northern California and some 36 years later 16 percent had developed dementia.

    Those who were overweight or obese but did not have a pot belly had an 80 percent increase in the risk of dementia compared to people with a normal body weight and abdominal fat level.

    The risk increase jumped to 230 percent among overweight people with a large belly and 360 percent among the obese with large abdomens.

    "Where one carries the weight -- especially in midlife -- appears to be an important predictor for dementia risk," Whitmer said.

    "These findings imply that the dangerous effects of abdominal obesity on the brain may start long before the signs of dementia appear."

    The Alzheimer's Action Plan: The Experts' Guide to the Best Diagnosis and Treatment for Memory Problems

    Related Content

    Bob DeMarco
    Bob DeMarco is the Founder of the Alzheimer's Reading Room and an Alzheimer's caregiver. The ARR knowledge base contains more than 3,811 articles with more than 306,100 links on the Internet. Bob lives in Delray Beach, FL.

    Original content Bob DeMarco, Alzheimer's Reading Room

    Mar 25, 2008

    Reducing the biological hallmarks of Alzheimer's disease

    "We have plenty of epidemiological evidence connecting activity, exercise and education with later onset of Alzheimer's, but it has never been clear which came first...Did the active lifestyle delay disease, or was there something inherent in a disease-resistant brain that led to a mentally and physically active lifestyle?"

    Enriched environment delays onset of Alzheimer's in mice

    A research group based at the University of Chicago has found that an enriched environment -- in this case more chances to exercise, explore and interact with others -- can dramatically reduce the biological hallmarks of Alzheimer's disease in mice that are genetically predisposed to the disorder.

    In the 11 March 2005 issue of Cell, the researchers show that mice raised in a deluxe setting – large cages filled with running wheels, colored tunnels and multiple toys -- had much less of the beta-amyloid peptides that are characteristic of Alzheimer's disease deposited in their brains than genetically similar mice raised in a standard environment. Mice from enriched settings also had more of an enzyme that breaks down amyloid as well as increased activity of several genes involved in learning and memory, brain cell survival and the growth of new blood vessels.

    "We have plenty of epidemiological evidence connecting activity, exercise and education with later onset of Alzheimer's, but it has never been clear which came first," said study-author Sangram Sisodia, PhD, professor of neurobiology, pharmacology and physiology at the University of Chicago. "Did the active lifestyle delay disease, or was there something inherent in a disease-resistant brain that led to a mentally and physically active lifestyle?"

    "This is the first demonstration," he said, "in a genetically clean, carefully controlled animal model showing that an enhanced environment can have such a tremendously beneficial impact, protecting the brain from the pathological hallmarks of this insidious disease."

    These findings support a "potentially causal inverse relationship between a more engaging, enriched life and AD progression," note Stanislav Karsten and Daniel Geschwind of UCLA in an accompanying editorial. They also provide "clear initial directions for exploring the role of the environment and the molecular pathways perturbed in AD and other neurodegenerative disorders."

    Sisodia, and colleagues from his lab -- Orly Lazarov, PhD, assistant professor of neurobiology, pharmacology & physiology and lead author of the study, and John Robinson, senior research technician -- studied mice carrying two mutated genes (amyloid precursor protein and presenilin-1) that predispose the animals to develop Alzheimer's disease early in life.

    At one month of age, nine of these mice were placed in the enriched environment and seven in standard housing. After five months, the researchers began to search for the pathological signs of AD in the mice's brains.

    They found that mice from the enriched environment had a dramatic reduction of amyloid deposits in their brains, including less than half the volume of amyloid deposits in the hippocampus and cortex, regions involved in memory and reasoning.

    The researchers also looked for genes that were activated at different levels in brains of mice from enriched versus standard housing. They identified 41 such genes, many of them already known to protect nerve cells. One of them was the gene for an enzyme that degrades beta-amyloid called neprilysin, which was at significantly higher levels in mice from the enhanced setting.

    These mice also showed greater activity for several other genes involved in memory and learning, the growth of new nerve cells, cell survival, and the growth of new blood vessels within the brain.

    The researchers also noted one "personality" difference among the mice in the enriched environment that influenced amyloid levels. Some of these mice were extremely active, frequently exploring their cages or running on the wheel. Others, the couch-potato mice, had the same opportunities for exercise but chose much less activity.

    The most active mice had the least beta-amyloid. Less active mice from the enriched environment had more and those from the standard housing, who got the least exercise, had the most.

    A lot of the process involves simple plumbing, Sisodia suspects, delivering blood to the brain and carrying harmful substances away. "It may be all about blood flow," he suggested. Exercise and mental activity can stimulate growth of new vessels while they help keep existing vessels in the brain open and functional, just like in the heart.

    "Whenever we find amyloid deposits in the brain we also see them in the vessels," he said. "We suspect a large part of this process is the growing inability of mice, or people, who are developing Alzheimer's to get rid of the substances that comprise amyloid deposits, to slice up the peptides, sweep them into the blood stream and ship them out of the brain."

    The take home message for humans, he said, is use it or lose it. "Activity helps, physical activity helps and mental activity helps," he said, "and the earlier you begin the better, a troubling notion in an increasingly inactive society. This is prevention, not therapy."

    About 4.5 million people in the United States have Alzheimer's disease, including about five percent of those aged 65 to 74. Risk increases with age.

    The National Institutes of Health, the Ellison Medical Research Foundation and the Alzheimer's Association funded this study. Additional authors include first author Orly Lazarov, John Robinson and Ya-Ping Tang of the University of Chicago; Ilana Hairston and Robert Sapolsky of Stanford; Zeljka Korade-Mirnics and Karoly Mirnics of the University of Pittsburgh; Virginia Lee of the University of Pennsylvania; and Lou Hersh of the University of Kentucky.

    The University of Chicago Medical Center
    Office of Medical Center Communications
    850 E. 58th Street, Room 106, MC6063
    Chicago, IL 60637
    Phone (773) 702-6241 Fax (773) 702-3171

    Mar 24, 2008

    Your Brain and Alzheimer's

    I ran across this very interesting tour of the brain on the website of the Alzheimer's Association. You can learn more about the brain and the Brain and Alzheimer's by following the link.

    Inside the Brain: an Interactive Tour

    Eight Types of Dementia Defined

    Dementia is a clinical syndrome of loss or decline in memory and other cognitive abilities. It is caused by various diseases and conditions that result in damaged brain cells.

    Alzheimer’s disease is the most common cause of dementia.


    This section provides information about the definition of dementia, the characteristics of specific types of dementia and the symptoms, risk factors for and treatment of Alzheimer’s disease.

    Dementia: Definition and Specific Types

    Dementia is a clinical syndrome of loss or decline in memory and other cognitive abilities. It is caused by various diseases and conditions that result in damaged brain cells. To be classified as dementia, the syndrome must meet the following criteria:

    • It must include decline in memory and in at least one of the following cognitive abilities:

    1. Ability to generate coherent speech and understand spoken or written language;

    2. Ability to recognize or identify objects, assuming intact sensory function;

    3. Ability to execute motor activities, assuming intact motor abilities, sensory function and comprehension
    of the required task; and

    4. Ability to think abstractly, make sound judgments and plan and carry out complex tasks.

    The Validation Breakthrough: Simple Techniques for Communicating with People with Alzheimer's Type Dementia

    You might get the impression from the title that this book is only for professionals, this is not the case. The validation theory works and it is simple to apply.

    The case studies are invaluable and provide you with specific situations that you are sure to encounter.

    I am convinced everyone involved with spouses or parents suffering from dementia or Alzheimers will benefit from by reading and utilizing this book.

    The book contains valuable techniques that are designed to help you communicate more effectively with your loved one. Once perfected you will be able to put away those feelings of frustration and helplessness. Importantly, the learned techniques will help you reduce stress for both the person living with dementia, and yourself.

    I give The Validation Breakthrough five stars and it is on my must read list.

    The Validation Breakthrough:
    Simple Techniques for Communicating with People with Alzheimer's Type Dementia