Alzheimer’s Disease Cooperative Study

January 2010, Issue No. 14

AD Info Network
Alzheimer’s Disease Information Network Monthly E-Newsletter

Special points
of interest:
Better Understanding 3
of Amyloid in AD
Free Resources from NIA 3 heimer‟s, you are probably already tak-
Currently Enrolling Studies 4
Follow us on Twitter 4 medical foods for additional help. Is this
This newsletter is
provided to educate
the public about AD
and clinical studies by
the UCSD Alzheimer’s
Disease Cooperative
Study
http://www.adcs.org
brainlink@ucsd.edu
Medical Food,
Nutritional Supplements and Alzheimer’s:
Do They Work and Are They Safe?
By Hillel Grossman, M.D.
Medical Director
Clinical Core, Mount Sinai Alzheimer‟s
Disease Research Center
What else can I do to help my memory?
If you or your loved one have Alz-
ing medication prescribed by your doc-
tor. Many people look beyond medica-
tions to dietary supplements or so-called
wise? Recent surveys have shown that
approximately 50% of elders take at
least one dietary supplement 1. Though
the label might claim that this pill or drink
can “improve memory” or “treat Alz- and Drug Administration (FDA) inspec-
heimer‟s” it is important to have a full tors are entitled to information about the
understanding about these products be- manufacture of these foods in terms of
fore making a decision to take one. cleanliness, consistency and quality con-
trol. Unlike drugs, however, medical
There are two broad categories for these foods do not need FDA review or ap-
non-drug products: nutritional supple- proval to determine that they actually
ments and medical foods. Nutritional help patients. They are subject to the
supplements include vitamins, minerals, rules related to the safety of foods only.
herbs, meal supplements, or sports nutri- A drug must typically have been tested
tion products. These supplements usu- on hundreds or thousands of people
ally come in a pill or drink form and are starting with healthy volunteers and then
promoted to healthy adults to maintain moving to people with the actual dis-
good health or to help with a specific ease. In contrast, nutritional supplements
function such as energy or memory. and medical foods do not need to be
Medical foods on the other hand are tested for efficacy – they are foods and
particular foods or diets that target peo- food that does not have to be useful or
ple with a specific disease and may re- even healthy (e.g. the ingredients of a
quire a doctor’s prescription. A specifi- custard doughnuts may be FDA-
cally formulated low protein diet for pa- approved but certainly are not healthy or
tients with kidney failure is an example of recommended regularly).
a medical food. These products are
regulated as foods, meaning that Food Let‟s look at Axona, an increasingly
Page 2
popular medical food targeted for Alzheimer pa-
tients. According to the company’s website,
AxonaTM (trade name for the AC-1202-
containing drink) “is a specially formulated
medical food intended for the clinical dietary
management of the metabolic processes as-
sociated with mild to moderate AD.”
If you try to unpack the claim above, you will see
the product is called a medical food (so outside
the purview of FDA drug regulations), and it is
targeted for Alzheimer‟s patients but does not
make claims to improve memory. Rather it is for
the “management of metabolic processes”. This
is a broad statement that doesn‟t mean much.
There are no „metabolic processes‟ in Alz-
heimer‟s that we understand sufficiently to rec-
ommend any specific intervention. This statement
is the equivalent of saying “patients with Alz-
heimer‟s should exercise and follow a healthy
diet”. It is true for all adults and has no proven
specific benefit for Alzheimer‟s. There are no
claims made that this food product will help mem-
ory or function, the primary concerns of Alz-
heimer patients.
Are supplements and medical foods safe?
“They are natural so they must be.”
Medical foods and food supplements are usually
made from natural ingredients categorized as
GRAS or generally regarded as safe. There is an
assumption of safety but the GRAS categoriza-
tion does not mean however, that they have been
proven to be safe at any particular dose. Medical
foods and supplements are still chemicals and
have the potential to cause side effects, and to
interact with other foods and medicines. More-
over, they are not required to undergo the exten-
sive safety testing that is required of drugs.
When the FDA approves a medication for com-
mercial use, it is attesting that the drug works and
that it is safe. It is important to remember that
supplements and medical foods are not regulated
by the FDA in this way.
So is there any use for supplements or medi-
cal foods in Alzheimer’s?
There very well may be an important role for sup-
plements in the treatment of Alzheimer‟s and the
grass roots use of these products demand that
they be studied rigorously. Several products sup-
plements have been tested recently for efficacy
with disappointing results. Ginkgo biloba, long
regarded as an aid to memory, unfortunately has
shown no benefit for Alzheimer patients when
compared to placebo 2, 3. DHA (docosahexaenoic
Alzheimer’s Disease Information Network
acid), a supplement in widespread use for heart
protection and memory support is a naturally oc-
curring omega 3 fatty acid, highly concentrated in
sea algae and the oil of fish who eat the algae. A
large multicenter trial conducted under the aegis
of the Alzheimer‟s Disease Cooperative Study
(ADCS) recently concluded that this supplement
had no benefit for the Alzheimer participants,
relative to placebo.
So how should we regard supplements and
medical foods?
Take the reports seriously but not literally. There
may be some promising compounds in your gar-
den or on the shelves of the health food store but
they need to be studied with the same rigor that
would be applied to a medication coming out of a
laboratory. While the recent studies of ginkgo and
DHA did not show these supplements to be help-
ful, they did set the standard for how to evaluate
nutriceuticals carefully and conclusively. If you
decide to take a nutriceutical keep in mind that
you are conducting an experiment of one: does
this help my loved one or me. Be vigilant for any
adverse effects and don‟t presume that if it‟s not
a drug you don‟t have to worry. Help build our
understanding of the role of nutriceuticals and
medical foods in Alzheimer‟s by supporting re-
search, participating in clinical trials and urging
others to do so as well.
1. Dima M. Qato, PharmD, MPH; G. Caleb Alexander, MD,
MS; Rena M. Conti, PhD; Michael Johnson, BA; Phil
Schumm, MA; Stacy Tessler Lindau, MD, MAPP
Use of Prescription and Over-the-counter Medications
and Dietary Supplements Among Older Adults in the
United States
JAMA. 2008;300(24):2867-2878.
2. Steven T. DeKosky; Jeff D. Williamson; Annette L. Fitz-
patrick; Richard A. Kronmal; Diane G. Ives; Judith A. Saxton;
Oscar L. Lopez; Gregory Burke; Michelle C. Carlson; Linda P.
Fried; Lewis H. Kuller; John A. Robbins; Russell P. Tracy;
Nancy F. Woolard; Leslie Dunn; Beth E. Snitz; Richard L.
Nahin; Curt D. Furberg; for the Ginkgo Evaluation of Memory
(GEM) Study Investigators
Ginkgo biloba for Prevention of Dementia: A Randomized
Controlled Trial
JAMA, November 19, 2008; 300: 2253 - 2262.
3. Birks J, Grimley Evans J. Ginkgo biloba for cognitive im-
pairment and dementia. Cochrane Database of Systematic
Reviews 2009, Issue 1. Art. No.: CD003120. DOI:
10.1002/14651858.CD003120.pub3
Page 3

ease-associated amyloid such as AD.

Search for New Cegelski L, Pinkner JS, Hammer ND, Cusumano CK, Hung

Anti-Amyloid Drugs Helps CS, Chorell E, Aberg V, Walker JN, Seed PC, Almqvist F,
Chapman MR, Hultgren SJ. Small-molecule inhibitors target
Better Understand Amyloid Escherichia coli amyloid biogenesis and biofilm formation. Nat
Chem Biol. 2009 Dec;5(12):913-9.
in Alzheimer’s Disease
By Michael Rafii, M.D.
Associate Medical Core Director
Alzheimer‟s Disease Cooperative Study
Free Resources from the
The bacterium that causes most Urinary Tract
Infections (UTIs), Escherichia coli, produces a
National Institute on Aging
form of amyloid. This amyloid attaches to human
cells to build biofilms, a barrier that helps the bac- Caring for a
terial infection resist antibiotics as well as immune
attack. Amyloid, of course, also forms in the cen- Person with
tral nervous system of patients with Alzheimer's Alzheimer’s
disease. Disease: Your
Easy-to-Use
Guide
Taking care of some-
one with AD can be
truly rewarding and
also very demand-
ing. Sometimes
caregivers feel like
they are on an emotional roller coaster. This
guide will help you understand and cope with the
many challenges of caring for a person with AD.

In searching for new anti-amyloid drugs for AD,

scientists (Cegelski et al, 2009) altered potential Forgetfulness:
UTI-fighting drugs originally selected for their abil- Knowing
ity to block bacteria's ability to make amyloid and
form biofilms and tested them in animal models of
When to Ask
AD. In these laboratory tests, the new drugs pre- for Help
vented beta-amyloid from aggregating into amy- Forgetfulness can
loid plaques. When scientists took the new com- be a normal part of
pounds back to a mouse model of UTIs, they re- aging. As people get
ceived a surprise. The altered compounds were older, changes oc-
also better at reducing the virulence of infection. cur in all parts of the
body, including the
Since the discovery of bacterial amyloid in 2002, brain. This guide
we now appreciate that amyloid is prevalent can help you deter-
among microorganisms, and that it is also part of mine what‟s normal and what could be a sign of a
normal cellular physiology. Assembly of amyloid more serious medical problem.
appears to be highly regulated in order to direct
its production at the right time and place, and to To order call 1-800-438-4380 or visit
prevent toxicity. By further studying amyloid pro- www.nia.nih.gov/HealthInformation/
duction in these systems, we will enhance our Publications
perspective on amyloid folding pathways and dis-

Alzheimer’s Disease Information Network

Page 4

Currently Enrolling The ADCS is Now on Twitter

Clinical Research Trials Want to know more about recent Alzheimer‟s dis-
Conducted by the ADCS ease news and developments? Follow us on
Twitter at http://twitter.com/ADCSComm
GAP/IgIV Study
Intravenous (IgIV) has been approved and used
successfully for over 20 years to treat a variety of
autoimmune and immunodeficient diseases. Be-
cause it contains anti-amyloid antibodies, IgIV is
being investigated in a Phase III study as a treat-
ment for Alzheimer's disease. For more informa-
tion, go to http://www.adcs.org/Studies/
IGIV.aspx

Happy New Year!

From all of us at the ADCS, we would like to wish
you and your family a happy and prosperous new
year! Thank you for subscribing!

If you have any questions or comments, please e-

mail us at Brainlink@ucsd.edu. We would love
to hear from you!
Nerve Growth Factor Study (NGF)
A Phase II clinical study of Ceregene's CERE-
110, a gene therapy product designed to deliver
nerve growth factor (NGF) to the brain for the
treatment of Alzheimer's disease (AD) is currently
underway. This study is a randomized, double-
blind, placebo-controlled trial and employs gene
therapy to deliver nerve growth factor (NGF) di-
rectly into the brain.

Five research sites are able to screen partici-

pants:

Georgetown University
Mount Sinai School of Medicine
University of Alabama at Birmingham
University of California, Los Angeles
University of California, San Diego

For research sites and further information, go to

http://adcs.org/Studies/NGF.aspx

Alzheimer’s Disease Information Network