By Kristine Dwyer, Staff Writer
Clinical trials are the final testing ground for
new treatments that are currently under
investigation. Each trial represents the results of
years of scientific thought, observation, and data
analysis and is only possible through the
participation of patients and their family members.
Clinical trials are the principal way that
researchers can discover whether a treatment is safe
and effective for patients, especially for those in
the early stages of the disease. Trials take place
at private research facilities, specialized AD
research centers, teaching hospitals and even at
physicians’ offices. Taking part in a clinical trial
can be a big step for both the patient and the
family so it’s necessary to discuss the expectations
and pros and cons of participation with the clinical
trials staff.
There are two kinds of drug trials available:
Treatment trials with existing drugs that assess
whether an already approved drug may be useful for
other purposes. For example, an arthritis treatment
may help in the prevention of AD.Treatment trials
with experimental drugs or approaches to discover
whether a new drug or treatment approach may help
improve memory function, decrease symptoms, slow the
progression of AD or prevent it altogether. Each one
of these clinical trials includes up to three
phases. Once these phases are complete and
investigators are satisfied that the treatment is
safe and effective, the research team can submit its
results to the Food and Drug Administration (FDA)
for review.
When a person signs up for a clinical trial, they
are asked to sign an informed consent form to ensure
that they are protected and well cared for during
the study. If a participant is unable to provide
informed consent because of memory loss, it is still
possible for an authorized representative (usually a
member of the family) to give permission. Next,
patients go through a process of screening to see if
they qualify and can safely participate before they
proceed with the study. Although clinical trials may
not produce miraculous results, many participants
believe that even if the benefit to them is small,
they are making a valuable contribution toward
future research. Family members have also found that
the best benefit of participating in a clinical
trial is the regular contact with the research team.
The team can be a link to education, provide advice
on the emotional and physical aspects of AD, and
offer supportive and helpful information.
The amount and variety of clinical trials underway
are a sign of the intensity of research to seek
solutions for a disease that robs the mind and takes
away the essence of a person’s life. Current
clinical trials are available on the Internet under
www.alz.org or by contacting the Alzheimer’s
Association or the Alzheimer’s Disease Education and
Referral Center (ADEAR) at 1-800-438-4380 (a service
of the National Institute on Aging).
Support for Caregivers:
Caring for a person with AD can be likened to
driving on an unfamiliar road, riding a roller
coaster or even walking on a tightrope. It can be an
incredibly stressful ride, yet rewards can also be
visible. The key is to balance your own needs
against those of the person you are caring for day
to day. Many caregivers find that they are stronger
than they ever thought possible and that they feel
rewarded knowing they have stayed committed to
helping a loved one during the difficult years.
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