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The division of Research conducts clinical psychiatry investigations with
patients. Research offers opportunities for volunteers to participate in studies
of potential new treatments including new medication and medication
strategies, new ultra-brief methods of psychotherapy. The division contracts
with research sponsors and industry to perform or advise on research projects
and plans. The division of Research offers training for psychiatry residents,
medical students, and graduate and undergraduate students interested in
acquiring research skills.
Clinical Trials:
Alzheimer's Disease
Valproate in Dementia Study
(VALID Study)
What is the VALID study?
VALID (VALproate In Dementia) is a research study to test whether valproate
(an anti-seizure drug) is effective in delaying, weakening, or possibly even
preventing difficult behaviors in people with early to middle stage AD, and
whether it slows the progression of AD itself. Researchers hope that slowing
the development of these common symptoms in AD may help reduce the
burden ont eh caregivers and delay the need for nursing home placement.
VALID is sponsored by the Alzheimer Disease Cooperative Study and funded
by the U.S. Government's National Institute on Aging, one of the National
Institutes of Health.
Who can participate in the study?
- The VALID study seeks 300 volunteers who:
- Have been diagnosed with probable Alzheimer disease;
- Are age 55-90;
- Speak English or Spanish;
- Have not experienced agitation or psychosis since the onset of AD;
- Have a study partner - a friend or relative who can accompany the
volunteer to all clinic visits and answer questions about him/her.
For more information, contact......Sandra Vicari, Ph.D., LCPC at 217-545-7671.
A Multicenter Vitamin E Trial for Aging Persons with Down Syndrome
Purpose and general plan of this research:
You may be able to participate in a research study designed to determine
whether high dose vitamin E (1000 international units twice daily), taken every
day for 3 years, will stop or slow down some of the changes that occur in
people who develop Alzheimer's disease (AD). Evidence indicates that persons
with Down syndrome over the age of 50 are more likely to get AD than other
older people. Some of the functional changes that occur in persons who
develop AD include a decline in memory, thinking, working and self-help skills.
Changes also occur in work habits, speech or walking. Vitamin E has been
shown to delay these functional changes in persons with AD in the general
population. We do not know whether it will help older people with Down
syndrome.
Description of the procedures you will be asked to participate in as part of this research:
This is a randomized and double-blind study. This means that each participant
will have approximately an equal chance of being assigned to receive either
the high dose vitamin E pills or placebo (inactive pills). Neither the participants
study nor the personnel will know who is receiving active medication or
placebo. All participants will receive multivitamin supplements. In the event of
a serious side effect, the identity of the treatment can be determined
immediately. The study will require the participant and his/her caregiver to
come to a local site for clinic visits every six months for 36 months. The
caregiver must be willing to:
- Accompany you to all of the study visits
- Monitor your taking of the study medication
- Communicate changes in your health status over the period of this study
If you agree to participate, the screening visit will determine your elgibility for
the study. Some basic information regarding your health, medical, social, and
work background will be collected. You will also be asked to perform a few
simple tests of memory and function. You will receive a physical examination
and two small blood samples (a total of less than 3 tablespoons) will be
collected. One sample is for lab tests to determine if you are in satisfactory
health to participate in the project and the other sample will be kept frozen
for future biochemical studies.
This research may involve the following risks and discomforts:
There are usually no major side effects or problems associated with taking
Vitamin E supplements. However, mild gastrointestinal side effects such as
upset stomach may occur. Because Vitamin E can worsen the problems of
people who have blood-clotting disorders, we will not allow a person with
Down syndrome to enroll in the study if blood clotting problems are detected
during the initial screening visit. Although there has been some anecdotal
evidence associated with increased bleeding with high dose Vitamin E, no
increased bleeding tendencies were described in 2 large clinical trials where
people with Alzheimer's disease and Parkinson's disease were given the same
dose of Vitamin E to be employed in this study. There might be slight pain
during the blood drawing (venipuncture), and there is a risk that a bruise may
develop at the venipuncture site. You may also experience temporary
dizziness or fainting. In extremely rare cases, a blood drawing can cause
phlebitis or an infection can occur at the puncture site. To reduce the chance
of these risks, only experienced medical personnel will handle the blood
drawing procedures, and sterile conditions will be maintained. Physical exams
and cognitive testing present practically no risks to you.
If you have an interest to participate in this three year project, please
contact Sandra Vicari, Ph.D. for additional information and to see if you live in
an area that is covered by a research site. (217-545-7671)
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