Maria Carrillo, Ph.D., is the Director of Medical and Scientific Relations for the
Alzheimer's Association in Chicago, Ill.
How should patients and their family members navigate the resources on
Alzheimer's disease when they first get a diagnosis?
Dr. Carrillo: It can be very, very difficult to navigate and very confusing for many
people. There are very good resources out there, but one of the first places to go
is, of course, your family physician or your neurologist. So whoever is taking care
of your loved one, that is always a great first step. After that, certainly the
Alzheimer's Association has a great web site, www.alz.org, where people can get
all kinds of information about the location of their local Alzheimer's Association
office and also local services that are available, clinical trials to participate in, or
about next steps in terms of your general health. There are also action steps for
planning for the future, in terms of what to look for from loved one, and what
stages your loved one will go through as the disease progresses. All of those
things are available on our Web site, but as well, people can get information in
any language by calling our national, toll free Helpline, 1-800-272-3900, and that
is a great resource for folks, 24 hours a day, whether it's an emergency -- my
loved is having an anxiety attack or has wandered off -- or just for general
questions, such as how do we work through the holidays as a family, how do we
get through Christmas with grandma having Alzheimer's disease. All those topics
-- and a lot more -- are available at the Alzheimer's Association website and
through our 800 number.
Some people hear the word clinical trials and they get scared. Is it a good
or bad thing to look into that for your loved or for yourself?
Dr. Carrillo: Clinical trials can be very beneficial for people, and there are
several reasons why. Certainly, when people are first diagnosed with Alzheimer's
disease, they feel sometimes a little bit out of control or like they do not have
control over their future. By joining a clinical trial, people can feel like they can
make a difference in the lives of their own family, for example, or make a
difference in the community at large. They can feel like they are taking control of
their healthcare, doing something about what is happening to them. Of course,
there are other benefits such as getting better general healthcare, usually without
cost for the length of the trial. They are checked more frequently, for example,
than just their yearly checkups with their family physician. They are checked by
neurologists who are trained to look for very subtle changes, and perhaps
improvements with a new medication. So there are several advantages to joining
clinical trials. The Alzheimer's Association always suggests that people think
about that as an option if they have been diagnosed with Alzheimer's and want to
take an active role in doing something about their diagnosis.
What are some of the risks of joining a clinical trial?
Dr. Carrillo: There are always general risks involved, but once a trial moves to
the Phase 3 trial stage and is a fairly large study, most of those risks are
relatively minimal. There are some questions that people should ask –
particularly, what the exclusion and, inclusion criteria are for trials. If there are
certain illnesses or strokes or cardiovascular risk factors that may not be included
in the trial, you may not be eligible for that particular study, but can continue
looking for another one to be in. Don't get discouraged. All the trials have
different criteria for participants. Other risks could include some side effects of
the medication. Those are usually fairly minimal. Otherwise, there would not be a
clinical trial for that medication. One other issue that is not really a "risk" is that
you could be on placebo instead of being on the drug, but that is an issue with
any clinical trial, and the corresponding potential benefit is that at the end of the
trial, you may get offered to be on the medication, especially if it was a positive
trial; and so I think that is a good benefit that outweighs the risk of being on the
placebo or the sugar pill. Also, it can feel like a risk if the drug company or the
sponsor of the drug trial asks you to not be on any other medications during the
length of the trial. People should be aware that sometimes drug trials can do that,
and you have to be very careful about the decisions that your family makes if a
loved one decides to participate in a clinical trial where they are asking them to
not take any other anti-dementia medication during the whole trial. Those are
decisions that have to made with the family.
How do you balance the excitement of a new treatment with the potential
Dr. Carrillo: There is a lot of hope about Alzheimer's disease clinical trials today.
There are so many good trials out there, but it is easy to let your hope kind of run
away with you and get too excited. I think one of the most important signs for a
legitimate trial is, first of all, to look for information about a trial on
www.clinicaltrials.gov and make sure that it is a registered trial. www.alz.org also
has listings of legitimate Alzheimer's clinical trials and can actually tell people
what clinical trials are going on in their area. We can help with that, but I think
another one of the big hints is that it should never cost a person any money to
participate in a clinical trial. These trials are paid for by sponsors, by research
grants, sometimes by the federal government through the National Institutes of
Health. It should never cost anyone money to join a trial. That is also another big
hint to keep an eye out for.
Dr. Edward Tobinick's enteracept treatment that claims to reverse memory
loss in minutes is not a clinical trial, correct?
Dr. Carrillo: That is not a documented, registered U.S. Food and Drug
Administration-approved clinical trial. They can call it a clinical trial if they wish --
if they are doing that treatment -- but the drug company itself that manufactures
the medication is not sponsoring that drug trial and is not looking to enter the
Alzheimer's therapy field with that drug. So that is a strong sign against the
credibility of that study. Certainly, when you are looking at a clinical trial that is
only testing two or three or four people, in general, it is something to be wary of. I
think it is very important to make sure that we check with clinical trials.gov., make
sure the FDA has approved those trials, that there is a legitimate sponsor out
there, and that it does not cost people money to join the study. Those are drug
trials that are tried and true, because they have been put through a series of FDA
regulations to make sure that they are conducted safely.
What are your thoughts on what Dr. Tobinick is doing?
Dr. Carrillo: I cannot make any specific comments about it, other than that the
Alzheimer's Association has made a statement that we do not feel it's appropriate
for people to join clinical trials that are not registered by the FDA. We do not feel
that off-label use of a medication is appropriate, and off-label use means it is a
drug that is used for another indication -- not for Alzheimer's disease. There are
drugs being tested in clinical trials that are legitimate. This particular one does
not even have the blessing of the company that sponsors it, so for that specific
reason, the Association cannot make any recommendations that people actually
join those types of clinical trials.
How do you balance hope for Alzheimer's with the reality of where research
Dr. Carrillo: We do our best at the Alzheimer's Association to present a realistic
view of what is happening today. We do not want to mislead people into thinking
that there is a cure tomorrow or around the corner, but there are lots of reasons
for us to be optimistic. There is so much research out there. Unfortunately, we
are hitting a time now where federal government investments in Alzheimer's
research and medical research are not really a priority for this country. We are
hopeful that that is going to change because federal dollars for research have
been stagnant and even dropping over the last few years, and we really need to
change that situation I order to keep that momentum going for Alzheimer's
disease. There are more than 10 large-scale treatment trials for Alzheimer's
disease today, which means that if one of those drugs works we can find a better
treatment for Alzheimer's disease within the next three years potentially. This is
really an exciting time because I think five of those 10 have just been launched
this year, in 2008, alone. And we learn something important from every study,
even the ones that don't work. We try to convey an optimism that we are finding
out more and more about the disease, and that it is not a hopeless case, at least
in the future, if not for people themselves that are suffering from it right now, but
at least for their loved ones, children and grandchildren.
What should someone consider before even approaching this subject of
Dr. Carrillo: It is important to understand that there is a difference between early
onset Alzheimer's and late onset, and there is a difference in terms of the genetic
tests involved. Early onset Alzheimer's affects people that could be in their 30s or
40s, early 50s. These people have a genetic link, and it's a deterministic gene
because it guarantees that you will get this disease if you have this gene. But this
group is actually very, very few people. They are perhaps 2 percent of the cases
of Alzheimer's that are deterministic Alzheimer's genes. This variation of
Alzheimer's usually runs in families. Those people know who they are in general
because very likely their parents and maybe grandparents have it, and probably
several more relatives, too. Most of the other 95 to 98 percent of the people with
Alzheimer's in United States and other countries are late onset Alzheimer's
disease, which usually strikes after age 65. For late onset Alzheimer's, one of the
clearest genes that have come forward is known as apoE4, and you can actually
get a genetic test for apoE4. However, it's very controversial, and you cannot
really do it easily at your physician's office, like you would a cholesterol test.
Plus, the Alzheimer's Association, at this time, does not recommend that people
should get that apoE4 late onset genetic risk test if they do not have any
Why don't you recommend it?
Dr. Carrillo: In general, the apoE4 genetic risk gene gives you very little
information because while it is associated with increased risk of Alzheimer's, we
do not know exactly how much it changes your risk. People that do not have
apoE4 get Alzheimer's disease, and people with apoE4 do not always get
Alzheimer's. So we do not really know what information it confers to a person or
a family. At this time, we try to focus on the warning signs for Alzheimer's
disease. If you are concerned about yourself or your loved one, I think it is
important to look at the Alzheimer's Association ten warning signs
regardless of whether you were apoE4 positive or not, that is what we would look
for. We would look for those warning signs of memory problems. If you are
introduced to someone, and then five minutes later you forget that you have
already met them; if you are having problems, for example, performing skills that
you normally do everyday, and then all of a sudden you start to have problems
tying a tie or making coffee in the morning. Maybe you start to have small
language problems where you cannot remember the word for a toothbrush, and
you start saying, "the thing I use to clean my mouth." You look for those types of
warning signs, and you can find those at www.alz.org, because that is really what
we think people need to focus on in terms of making an earlier diagnosis and
making sure their loved one gets the help that they need.
If you do decide you are going to go through genetic testing, what do you
need to think about before you do it in terms of talking to people and your
own mental well-being?
Dr. Carrillo: As I said, the Alzheimer's Association does not recommend that
people without symptoms get an apoE4 genetic test at this time. But if people
want to go ahead and do that, there are things that people should think about. It
is very controversial, again, because we are not quite sure what information it
actually conveys to a family; but also, it's important that if you go through with
that, you do it with a consultation of a physician or a genetic that could help a
family deal with and understand the results -- what does that mean now that I
know I am positive for apoE4, and what steps might I want to take? In reality, the
steps that one would want to take are steps that we would take anyway
regardless of whether we are apoE4 positive or not, because we are all at risk.
We are all an aging population, and we want to age as healthfully as possible.
Those things that reduce our risk -- including watching your cardiovascular risk
factors, watching your weight, watching your high blood pressure, making your
cholesterol stay low, watching your diabetes if you have diabetes, exercise -- all
those things should be done regardless of apoE4 status. Even more than that,
we caution people to make sure that they are very careful with their medical
records, because we know that medical records are private, but sometimes
insurers or employers can have access to those records. There was the GINA
Act passed this year, that is the Genetic Information Nondisclosure Act, which
protects people from discrimination based on their genetics from employers and
from insurers, but that does not protect people from, for example, long-term care,
from disability, from other life insurance. So people should be very careful when
they consider genetic testing.
So there is a lot to think about in terms of not just your mental health and
how you are going to feel, but the logistics?
Dr. Carrillo: Absolutely. It's a lot to consider and to think about. We want to
ensure that vulnerable people are protected as much as possible, and that their
medical records and their history are protected as well.
One of the myths surrounding Alzheimer's is a connection to aluminum. If I
am cooking and using an aluminum pot or pan, is that a cause of
Dr. Carrillo: There was some research done in the 1960s that pointed to
aluminum possibly contributing to Alzheimer's disease. That has been fairly well
researched since then, and there are no strong links found that have ever
pointed to aluminum increasing risk or causing Alzheimer's disease. We also
know today that the absorption of aluminum into our bloodstream from pots and
pans, from drinking from cans, from even underarm deodorant that could contain
aluminum is so small that it is not sufficient, even on the daily basis, to reach the
levels that were tested when they did these studies in animals back in the 60s.
Nobody's following aluminum as a major cause of Alzheimer's disease today.
What about dental fillings?
Dr. Carrillo: There is absolutely no credible research pointing to silver fillings as
a cause of Alzheimer's disease, and that is the same for aspartame. There is
absolutely no basis for that. I think the Food and Drug Administration had looked
at many, many studies involved in aspartame, and none of them came up
positive for causing Alzheimer's disease. So neither fillings nor aspartame will
cause Alzheimer's disease.
What are some of the specific signs that someone has Alzheimer's as
opposed to age-related forgetfulness?
Dr. Carrillo: One of the myths for Alzheimer's disease is that it is just normal
aging, and it's really not. When we look at a very vibrant 60-year-old, we do not
imagine them forgetting their daughter or son's name or spouse or partner's
name. That is not normal, and so we know that Alzheimer's disease is not normal
aging. Now there are certainly different cultural differences. There are certain
cultures that feel that Alzheimer's disease is a natural part of aging, and the
Alzheimer's Association works to educate people about this being a disease, and
this being a disease that kills you. It is not a benign disease that just happens
and that you just live with. It is a disease that will ultimately kill you because you
will forget how to eat sooner or later, and you will forget how to swallow, and so
ultimately it does cause death. We do continue to fight that myth that it is just
normal aging, and there is a lot of information about how to spot those warning
signs at www.alz.org.
What about the difference between men and women?
Dr. Carrillo: That is a topic of continuing research. There are certainly more
women than men affected by Alzheimer's disease today. There is a general
thought amongst researchers that it is because women live longer than men, but
also there is some research examining the fact that estrogen could be protective,
so women who are on hormone therapy might be benefiting as opposed to
women who are not. There is a lot of research, but none of it has really pointed
us in a clear, strong direction as to why there are more women than men who
How important is it to consider your family history?
Dr. Carrillo: Most people will be touched by Alzheimer's disease in their lifetime,
whether it is a friend or an immediate relative or a loved one. It is important to
think about how long your loved ones lived, because research has shown us, and
statistics have shown us, that if we live long enough, many people will develop
Alzheimer's disease once they are past the age of 85. One out of two Americans
who live past age 85 develop Alzheimer's disease. So it is important to
remember that fact, and take charge of your future by committing to live as
healthfully as possible and watch your medical numbers and make sure that you
stay active physically and mentally.
Is it true that suffering head trauma leaves you at greater risk for
Dr. Carrillo: Research points to the fact that head trauma could trigger or
exacerbate symptoms of Alzheimer's disease. Certainly people like football
players or people playing in contact sports should be very careful, especially if
they have a family history of Alzheimer's disease. We do know that research is
fairly solid at this time. We do not know the exact reasons why, so researchers
are looking into that right now.
What else should people know about Alzheimer's disease?
Dr. Carrillo: I think it's very important for people to think about the warning signs,
and understand the positive value of early detection. It is so important for people
to get help as soon as possible and to think about joining clinical trials if they are
diagnosed early. It is also important for people to remember that we need more
funding for clinical trials on the federal level, and so people should be out there
contacting their congressmen, trying to increase federal funding for Alzheimer's
disease research because we can combat this disease, and we can find a cure.
We just need the resources to do it because all the signs point to the fact that we
are moving in the right direction.
END OF INTERVIEW
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