Alzheimer's Association Update for May 2009

Article Outline

• HBO Documentary Explores AD
• Association Urges Caution When Considering Medical Foods for AD
• National Conference Examines Prevalence of AD
• Association Highlights Warning Signs of AD

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HBO Documentary Explores AD 

Advances in Alzheimer's disease (AD) science and the effect of AD on families, including children and caregivers, will be featured in the four-part documentary The Alzheimer's Project scheduled to appear May 10–12 on HBO. The Alzheimer's Association played a key role in the development of the documentary, opening the doors of its International Conference on Alzheimer's Disease for the filming of science segments, identifying and introducing many of the families and scientists whose stories are told in the films, and contributing to the documentary's companion book and viewing guides.

One part of the documentary, “Momentum in Science,” details the explosion of knowledge in the scientific and medical communities—from imaging the earliest signs of AD to understanding the roles that genetics and lifestyle might play in the disease. Two years in the making, “Momentum in Science” is scheduled to air in two segments on May 11 and 12. These segments, as well as 15 supplemental short films, take viewers inside the laboratories and clinics of 25 leading AD scientists and clinicians.

Other parts of the documentary highlight the lives of individuals with AD and their families, the sacrifices and successes of caregivers, and the experiences of children whose parents or grandparents have AD.

For more information on The Alzheimer's Project, including information on how to host or view the films after their primary airing on HBO, visit www.HBO.com/Alzheimers.

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Association Urges Caution When Considering Medical Foods for AD 

As the leading voluntary health organization in AD care, support and research, the Alzheimer's Association takes seriously its role of communicating to the public information about new treatments for Alzheimer's disease.

Five drugs for AD have been approved by the U.S. Food and Drug Administration (FDA), four of which are commonly used. To obtain FDA approval, a drug must undergo the agency's rigorous, multi-year, multi-phase evaluation process, which ensures its safety and effectiveness. As an added measure, the FDA oversees how approved drugs are manufactured to ensure purity. When a drug is approved by the FDA, the Association can state with confidence that the drug has met standards of safety and effectiveness.

The Association is aware of several products containing dietary supplements or agents naturally produced by the body that claim to beneficially affect AD. These products, as well as associated claims, have not been reviewed by the FDA. The manufacturers of some of these products intend to market them as “medical foods.” This is a subject of concern as the Association strives to fulfill its mission of providing the public with scientifically accurate information about treatments for AD.

A medical food is defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

Federal regulation 21CFR101.9(j)(8) requires that a product meet all of the following criteria to be considered a medical food:

Labels for medical foods cannot make drug claims or state that the product alleviates symptoms because medical foods are not drugs. Such claims can be grounds for possible enforcement action.

In contrast to FDA-approved drugs, no premarket review process exists for medical foods. Instead, they are regulated after they have become available to consumers; however, new products do not always come to the attention of the FDA.

The FDA has established a compliance program for medical foods. The objectives of this program are to obtain information on manufacturing processes and quality assurance and to collect samples for nutritional analysis and analysis for microbes such as Salmonella and Staphylococcus. If violations are found, the FDA can take action.

Historically, medical foods have developed to address the needs of individuals with inherited errors of metabolism, such as phenylketonuria (PKU), in which an individual is born with low levels of an enzyme necessary to convert a particular type of amino acid into another type of amino acid after protein has been consumed. PKU and other errors of metabolism are quite rare.

Because medical foods do not undergo premarket FDA review, the Association cannot be assured that data supporting their effectiveness (if such data exist) have undergone scientific scrutiny. In light of the lack of rigorous scientific data to substantiate the use of medical foods, the effectiveness of medical foods is difficult for the Association to assess. Unlike PKU, no clear role for medical foods exists at this time for AD, as AD does not have “distinctive nutritional requirements, based on recognized scientific principles.” Current evidence does not document the efficacy of a medical food that substitutes for or supplements a balanced diet. The Association encourages a healthy diet rich in nutrients, as well as physical, social, and mental activity, as steps to support brain health.

Much is unknown about the effects of medical foods, both when taken alone and in combination with drugs. Whether medical foods will interact with and possibly decrease the effectiveness of drugs taken for AD and other conditions is not known, although makers of medical foods may claim that they can be used with drugs prescribed by one's physician.

The Association recognizes the growing market presence of medical foods and will continue to monitor new products that make AD claims. The Association will also continue to monitor advances in AD science, including advances relating to nutrition and AD that may cause the scientific community to revisit the notion of a medical food for AD.

To best serve individuals with AD and their families, the Alzheimer's Association strongly encourages makers of medical foods that claim to affect AD to conduct definitive clinical trials that will establish their products' effectiveness. Until then, consumers should become familiar with their individual insurance plans to determine whether coverage for medical foods is included. Because medical foods are not drugs, insurance coverage may vary considerably. A decision to purchase products that may not be effective and may not be covered by insurance should be made carefully.

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National Conference Examines Prevalence of AD 

Nearly 100 leaders in the epidemiology of dementia gathered in Washington, D.C., in March to attend the first Prevalence and Trends of AD and Other Age-Related Cognitive Disorders conference, co-sponsored by the Alzheimer's Association and National Institute on Aging. The intense day-and-a-half meeting tackled such complex issues as understanding the reasons for differences in prevalence numbers for AD and trends in prevalence and incidence estimates for AD and other dementias.

Diagnostic criteria used to define AD or other dementia and challenges in applying those criteria were identified as important factors in varying estimates of prevalence and incidence and were underscored in two sessions devoted to related topics. Included were presentations on assessing dementia in culturally diverse populations, such as older Mexican Americans, African Americans, and the oldest old, and the impact of culture and literacy on evaluating cognitive impairment and dementia. Changes in diagnostic criteria for AD and other dementias and the increasing importance of understanding the spectrum of cognition from health to impairment were also addressed.

Case definitions for dementia can be accomplished by direct (active) evaluation of individuals or indirect (passive) methods such as a review of medical records. Active compared with passive case-finding may produce different estimates; the impact of these differences on national prevalence estimates were examined in other sessions. After-dinner sessions provided data on estimating the global burden of dementia and a closer look at the sources of variability in U.S. prevalence estimates of dementia.

The final day examined trends in prevalence and incidence in estimates of Alzheimer's and other dementias. Trends in cognitive impairment were also evaluated. Options for reducing case ascertainment costs (the costs related to determining whether an individual has Alzheimer's or other dementia) were addressed in the final sessions of the meeting.

Additional details about the presentations, discussions, and potential future research directions and challenges will be provided in an executive summary, which will be submitted for publication.

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Association Highlights Warning Signs of AD 

As part of its efforts to raise awareness of the signs of AD among the public and among physicians and other health professionals, the Alzheimer's Association has released a revised version of the 10 Warning Signs of Alzheimer's disease^©. These signs are designed to be more inclusive of the younger-onset experience and incorporate the comments of five tiers of reviewers to enhance their usability. The new signs were also analyzed by health professionals and scientists to ensure their consistency with the latest developments in AD research. Members of the Association's Early-Stage Advisory Group, consisting of individuals with dementia, provided their input as well. Among the changes are the addition of a new warning sign addressing visual and spatial challenges in individuals with AD, as well as discussion on withdrawal from activities and difficulties with planning and problem-solving as potential signs of AD.

“These revised signs are the centerpiece of the early detection campaign,” said Shelley Morrison Bluethmann, MA, MPH, director of early stage initiatives for the Alzheimer's Association. “By spreading awareness of these signs, we hope to increase early detection of Alzheimer's disease among the American public, both at home and in the doctor's office.”

The new signs are listed by how commonly they occur. They reflect a movement away from the use of “normal” to describe an individual's experience with aging. The list promotes the idea of a range of behaviors being associated with each sign and that individuals should consider the signs in relation to behaviors that are typical for them.

Visit www.alz.org to learn more about early detection of AD and the benefits of early detection for physicians and for people living with dementia. For more information on the 10 signs, please visit www.alz.org/10signs.