 Mount Sinai School of Medicine • Clinical Trials
RAGE Study
Researchers are participating in a nationwide study that
will test an experimental treatment, RAGE Inhibitor, to
target the source of Alzheimer’s disease (AD). One of the
proteins that surround the amyloid plaques in AD patients,
called receptor for Advanced Glycation Endpoints (RAGE
for short) binds to amyloid and may promote nerve cell
damage. By inhibiting the RAGE protein, plaque formation
could be reduced. Volunteers will receive either active
study drug or placebo (inactive pill). All participants will
be monitored carefully at the research clinic throughout
the study. Participants are eligible to participate if they are
age 50 or older and have mild-to-moderate AD, have not
had any serious or unstable diseases within the past three
months, do not have Type 1 or Type 2 diabetes and have a reliable caregiver who can accompany them to all study
visits. For more detailed information please contact Tessa Lundquist at
212-659-8885 or Tessa.lundquist@mssm.edu. MSSM GCO 08-0194
IRB approved thru 5/12/2009
A Home-Based Assessment (HBA) Study for Memory
Protection Research
We are seeking healthy volunteers, 75 or older, to participate
in a nationwide research study to examine methods
to evaluate memory and thinking skills from the home.
Currently, in order to participate in Alzheimer’s disease
research studies, volunteers must visit a clinic to meet with
researchers. The Home-Based Assessment study will look
at three types of home evaluation methods — a telephone,
electronic kiosk or mail-in forms — to determine if there
may be a better way to gather study information and track
memory and thinking-related changes over time. Participants
will be assigned by chance to one of the three methods
and their memory and thinking skills will be evaluated
using their particular method monthly, quarterly or annually.
Participants will also have an in-person screening
evaluation visit that will include a physical and neurological
exam, a medical history, and some cognitive testing.
Participants will also be given a multi-vitamin to be taken
twice daily, as the study will examine how well the different
methods report pill-taking behavior. At the end of the
4-year study, participants will undergo a final in-person
evaluation. For more information, please contact
Jessica Egan at
212-241-8329. GCO#91-208 (13);
Principal Investigator: Jane Martin,
Ph.D., MSSM IRB approved through 08/31/2009.
A Trial of a Nutritional Supplement in Alzheimer’s
Disease (AD)
We are seeking patients with AD to participate in a research
study on an antioxidant formula containing resveratrol.
Some study participants will receive the formula and
some will receive a placebo (sugar pill). Participation in
the study includes memory testing, neurological exams,
and blood tests. Resveratrol may reduce brain cell
damage caused by harmful chemical byproducts. This
study is investigating if resveratrol can help the cognition
of AD patients. The study will be conducted over 12
months and is funded by the Alzheimer’s Association.
For more information, please contact our ADRC research coordinator
at 212-241-8329. GCO #05-1394(0001),
Principal Investigator:
Mary Sano, Ph.D., MSSM IRB approved through 4/30/09.
The Development of NIC5-15 in the Treatment of
Alzheimer’s Disease (AD)
We are seeking patients with AD to participate in this
randomized, double-blind, placebo-controlled trial of a
dietary supplement. This supplement has anti-diabetic
effects in people and has been shown to improve memory
in laboratory animals. It also reduces the production of
amyloid in test-tube conditions. Amyloid is the major
ingredient of the Alzheimer’s plaques. The purpose of the study is to determine whether this product is safe
and effective in treating AD and what dose is best. This
natural product (called NIC5-15) is found in many foods,
including soy beans, and has been already approved by the
Food and Drug Administration (FDA) for use as a dietary
supplement. For more information, please contact Sirisha Nandipati
at 212-241-1514. GCO # 05-0090 (0001 01); Principal Investigator: Hillel
Grossman, M.D., MSSM IRB approved through 12/19/2008.
Age at Onset and Cardiovascular Risk Factors in Very
Late-Onset Alzheimer’s Disease (AD)
The overall aims of this project are to examine the role of
cardiovascular risk factors for cognitive decline and AD
in elderly men. A growing body of evidence indicates
that risk factors for cardiovascular disease also increase the
risk of developing both vascular dementia (VaD) and AD.
Most, but not all, of the evidence comes from research
that has studied predominantly women, especially among
the very old. In this project, we will conduct an extensive
CvRF assessment in an elderly male veteran sample,
recruited through the Bronx Veterans Affairs Medical
Center. Male veterans, 75 years old and older with no
memory problems and no history of stroke (TIAs and
mini-strokes are acceptable) may qualify to participate
in this research study which consists of comprehensive
interview including memory and thinking tasks, health
and medical histories and a blood draw (approximately 3
tablespoons). We will also look to follow-up every year.
For more information, contact our research coordinator at 718-367-5727.
GCO#79-141, Project 4, Principal Investigator:
Jeremy Silverman, Ph.D.,
IRB approved through 3/31/09.
Brain Tissue Donation Program
The goal of this program is to improve existing treatments
and to develop new treatments for AD, which is not
possible without the generosity and altruism of individuals
who partner with Mount Sinai by participating in our brain
donation program. Therefore, men and women, with and
without memory impairment are eligible to provide their
“intent” to consent for this program. There are several
benefits to participation and we have specially trained staff
available to discuss these benefits, the donation process,
and any related concerns that you and your family might
have. For more information, please contact Karen Dahlman, Ph.D.
at 212-241-1844. GCO #84-119 and #79-141, MSSM IRB approved
through 3/31/09.
Note: Spanish-speaking participants are welcome in all studies. All
study participants receive reimbursement for any related expenses.
Participants without AD receive monetary compensation for their time.
If you are interested in any of the above research studies, please contact
the Alzheimer’s Disease Research Center
at 212-241-8329. Mount
Sinai also has Satellite clinics specializing in AD and other Memory
Disorders located at:
Elmhurst Hospital in Queens: 718-334-3983
Bronx VA Medical Center: 718-584-9000 ext. 5199
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