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Jump To: Columbia University Clinical Trials↓
NYU School of Medicine↓
Mt. Sinai School of Medicine↓
Treatment Studies
GLAD: The Gammaglobulin Liquid for Alzheimer’s
Disease Trial
This is a Phase III research study of intravenous immune
globulin (“IGIV”) in mild to moderate AD. Men and
women who are 50 to 85 years old with mild to moderate
AD may be eligible to participate. For more information, please
contact Ruth Tejeda at 212-305-7661.
Study of Bapineuzumab (AAB-001) Administered
by IV
Infusion in Alzheimer’s Disease (ICARA)
This is a Phase III research study of bapineuzumab administered
by IV infusion which researchers hope will attach
to the amyloid protein in the brain and help the body to
remove it. Individuals diagnosed with mild to moderate
probable AD who are 50 to 88 years old may be eligible to
participate. For more information, please contact Evelyn Dominguez
at 212-305-2371.
Study of BMS-708163 in Patients with Mild to Moderate
Alzheimer’s Disease
This is a Phase II study of the safety and tolerability of BMS-
708163, an oral compound, in men and women age 50-
90 who have been diagnosed with mild to moderate AD.
The study includes a 12-week treatment period followed
by a 12-week follow-up period. For more information, please
contact Evelyn Dominguez at 212-305-2371 or edd5@columbia.edu.
Study of ACC-001 Administered Subcutaneously in
Alzheimer’s Disease (AD)
This is a Phase IIa research study of ACC-001 administered
by injection. Men and women with mild to moderate
AD who are 50 to 85 years old may be eligible to
participate. For more information, please contact Evelyn Dominguez
at 212-305-2371.
Study of Memantine in Frontotemporal Dementia (FTD)
This is a Phase IV research study to determine if Memantine
is effective in slowing the rate of behavioral decline in
FTD. English-speaking men and women who are 40 to
80 years old and who have been diagnosed with FTD or
semantic dementia (SD) may be eligible. For further information,
please contact Lynda Mules at 212-305-2077.
Metformin in Amnestic Mild Cognitive Impairment
(MCI)
This is a 12-month research study of metformin, a medication
effective in the prevention and treatment of diabetes.
We are testing metformin in people with MCI. We are
seeking people over the age of 55 who are overweight or
obese and have memory complaints. For further information,
please contact Dr. Jose Luchsinger at 212-305-4730.
Antipsychotic Medication Treatment of Psychosis and
Behavioral Dyscontrol in Alzheimer’s Disease (AD)
This research study uses risperidone (an FDA-approved
antipsychotic medication) to treat people with AD who
suffer from hallucinations, delusions, agitation, and/or aggression.
Treatment continues over 48 weeks. Each participant
must have a caregiver to assist with adherence to
treatment and provide information. For further information,
please contact Karine Cunqueiro at 212-543-6132.
Antidepressant Treatment Studies for Combined
Depression
and Memory Complaints
We are conducting medication treatment research studies
for individuals age 50+ with both depression and mild
memory and/or concentration difficulties. The studies offer
neuropsychological testing for memory and psychiatric
evaluation of mood. Treatment is provided for eligible
individuals at no cost for at least 6 months. For more information,
please contact Amma Baker at 212-543-5067.
Other Studies
African American Genetics Study and Health and
Cognition Study among African American Women
The African American Genetics Study, for people over the age of 60, looks at genetic risk factors for Alzheimer’s disease among African Americans. The Health and Cognition Study among African American Women investigates issues of aging, cardiovascular health and cognition among African American women 40 years or older. Both studies involve an interview to include memory and thinking tests, questions about your health and experiences, and a blood draw. For further information, call Raquel Cabo at 212-305-1893.
Brain Imaging Study Measuring Changes in Cerebral
Blood Flow and Cognition with Age
We are seeking healthy individuals and people with memory
complaints or with Alzheimer’s disease, age 55 to 85, to
participate in a research study using Arterial Spin Labeling
(ASL), a technique that uses MRI to measure cerebral
blood flow in the brain. The study consists of three visits
and includes an MRI and memory testing. Participants will
be compensated. Please contact Brittany Holmes at 212-305-7846 for
more information.
Genetic Linkage Study
We are seeking families of all nationalities and backgrounds
for a study that seeks to identify genes that may increase
the risk for developing Alzheimer’s disease (AD). If your
family has at least two living siblings diagnosed with AD who are 60
years old or older, please call Jennifer Williamson at 212-305-4655.
Predictors Study
This research study is for people who are 55 to 90 years old
who have been diagnosed with Alzheimer’s disease and/or
Dementia with Lewy Bodies. Participation includes initial
medical evaluation and testing to assess memory and
cognitive functions. This longitudinal study requires biannual
visits which include memory testing and answering
questions about daily activities. For more information, please
call 212-305-1987.
Memory Problems II: Course and Predictors of
Outcome
This research study for people with and without memory
complaints who are 55 to 90 years old includes medical
evaluation by physicians who specialize in memory disorders,
and testing to assess memory and intellectual functions.
Visits and monitoring will take place annually for
7 years. At the initial visit only, an MRI scan, two PET
scans and a lumbar puncture will be performed. Participants
will receive reimbursement. For more information, please
call 212-543-5025.
Brain Donation Program “Give the Gift of Knowledge”
Brain donation allows valuable information to be obtained
regarding normal aging and diseases that affect memory.
This information may be useful towards the goal of developing
more effective treatment strategies. If you or a family
member wish to learn more about this program, please call Arlene Lawton,
RN at 212-305-9086.
Lucy G. Moses Center for Memory and Behavioral
Disorders
Changes in memory and thinking abilities can occur from
a variety of conditions, not just Alzheimer’s disease. Taub
Institute specialists offer a thorough multidisciplinary evaluation
of memory and thinking difficulties at two locations:
The Neurological Institute, 710 West 168th Street, New
York; and Columbia Presbyterian Eastside, 16 East 60th
Street, New York. For appointments, call 212-305-6939.
TREATMENT STUDIES
Clinical Trial of Anti-Amyloid Antibody Bapineuzumab
in Mild to
Moderate Alzheimer’s Disease (AD)
This 18 month phase III “immunotherapy” study is testing
the safety and effectiveness of Bapineuzumab, an experimental
antibody treatment that may reduce beta-amyloid,
one of the important toxic proteins that contribute to the
development of AD. We are enrolling patients with mild
to moderate AD who receive intravenous doses of either
drug or placebo to see if further progression is slowed. For
more information, please call Erica Maya or Jessica Lerer at 212-263-
5845 or 212-263-5708.
Clinical Trial of Anti-Amyloid Antibody Treatment with
IGIV in Patients with Mild to Moderate Alzheimer’s
Disease (AD)
We are enrolling participants for a clinical trial to test the
safety and effectiveness of Intravenous Immune Globulin
(IGIV, Baxter) or placebo in participants with mild
to moderate AD. This treatment may interrupt the processing
of a protein in the brain, beta amyloid, which is
thought to play an early role in the pathology of AD. This
18-month study will enroll patients with mild to moderate
AD. Participation involves regular visits, repeated MRIs,
and biweekly infusions both at NYU and eventually in the
participants’ homes. For more information, please call Erica Maya
or Jessica Lerer at 212-263-5845 or 212-263-5708.
Clinical Trial of Dimebon for Slowing the Progression
of Alzheimer’s Disease (AD)
This trial is testing the effectiveness of a novel antihistamine
compound (Dimebon) as a potential treatment of mild to
moderate AD. Eligible participants who are diagnosed with
AD will receive one of two doses of Dimebon or placebo for
12 months. Study participation involves approximately ten
visits to the study center over twelve months with repeated
safety and memory evaluations. For more information, please call
Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.
Upcoming Clinical Trials
We will soon be seeking to enroll participants in two new
trials involving anti-amyloid investigational drugs, one administered
intravenously to AD patients and another orally
to MCI patients.
Early AD Diagnosis
Longitudinal Study of Normal Aging, Mild Cognitive
Impairment (MCI) and Alzheimer’s Disease (AD)
Participants receive a comprehensive diagnostic evaluation
and are re-evaluated every year. The goal is to improve
early diagnosis and better understand the clinical course
and causes of age-related cognitive decline and AD. For
more information, please contact Emma Shulman, CSW at 212-263-5756
or Thet Oo, M.D. at 212-263-8088 or thet.oo@nyumc.org.
Clinical Correlates of Longitudinal PET Changes in
Alzheimer’s Disease (AD)
The goal is to assess the value of combining FDG-PET
imaging (brain metabolism) with cerebrospinal fluid (CSF)
biomarkers and PET amyloid imaging (shows brain amyloid)
in predicting cognitive decline. We are enrolling
subjects with mild AD, MCI, and normal subjects over age
20. Participants receive a comprehensive medical evaluation,
neuroimaging (MRI and PET), memory testing and
a lumbar puncture. Participants receive results and are
compensated for their time and effort. For further information,
please contact the Study Coordinator at 212-263-7563.
Predictors of Cognitive Decline in Aging
This project investigates the relationship between plasma
amyloid levels and the brain vascular response to CO2
(measured with MRI) in persons with mild AD, MCI or
normal aging. Additional tests include memory evaluations,
structural brain measurement and tau levels in CSF.
Participants receive a comprehensive medical evaluation,
neuroimaging (MRI and ASL), memory testing, and
a lumbar puncture. Participants receive results and are compensated for their time and effort. For further information,
please call Kenneth Rich at 212-263-7563.
FDG-PET Study on Family History of Alzheimer’s
Disease (AD)
We recently discovered that children of mothers with AD
appear to be predisposed to reductions in brain glucose
metabolism, and may also be at increased risk for developing
AD (compared to children of AD fathers and children
of parents without AD). This NIH funded study is
recruiting cognitively normal individuals ages 25-85 with
either a maternal or paternal family history of AD, as well
as individuals with no family history. The project measures
brain activity using a technique called positron emission
tomography (PET). The PET uses a tracer (FDG) to
measure brain glucose metabolism. Participants receive a
comprehensive medical exam and also are offered medical,
lifestyle and risk consultation. For more information, contact
Dr. Lisa Mosconi at lisa.mosconi@med.nyu.edu or John Murray
at
john.murray@med.nyu.edu. You can also reach us at 212-263-7563.
Assessment of Human STEM Cells with Magnetic
Resonance Spectroscopy in Normal Elderly and
Alzheimer’s Disease (AD)
We are investigating if the signal from neural stem cells
measured with Magnetic Resonance Spectroscopy (MRS)
can be detected, and if it differs between normals and individuals
with AD. We are enrolling subjects with mild
AD and normal persons with and without memory complaints.
All receive a comprehensive medical evaluation,
neuroimaging (MRI), memory testing and a lumbar puncture.
Participants receive results and are compensated for
their time and effort. For further information contact the Study
Coordinator at 212-263-7563.
Amyloid in the Lens of the Eye
We are recruiting normal individuals and individuals with
mild AD to help develop an early screen for AD which
involves visualizing amyloid in the lens of the eye. Amyloid
protein behaves abnormally in the brains of people at
risk for developing AD. A new technique makes amyloid
in the lens of the eye detectable, and this project will assess
whether it has diagnostic value. Participants also receive
a complete neurological evaluation, MRI and LP and are
compensated for their time and effort. For further information
contact Anna Hemraj at 212-263-1091.
Helping Caregivers
Counseling and Support for People Caring for a Parent
with Alzheimer’s Disease (AD)
The purpose of this NIH-funded study is to determine the
effectiveness of a comprehensive counseling and support
intervention for people who care for parents with AD. Participants are randomly assigned to one of two interventions.
All have access to resource information and support
from experts as needed. Those in the enhanced group
meet with a counselor individually and with other family
members. For more information, please contact Olanta Barton at 212-
263-5710 or olanta.barton@nyumc.org.
Early Stage Support Group Evaluation of Outcomes
This study offers facilitated support group meetings to
people in the early stages of AD and an assessment of their
benefits. Previous studies suggest these groups may alleviate
depression and social isolation, enhance coping skills,
improve self esteem and provide education and mental
stimulation in a safe environment. For more information, please
call Ursula Auclair, LCSW at 212-263-2245.
Memantine (Namenda™) and Individualized
Alzheimer’s Care
The goal of this 1 year study for middle or late stage AD is
to determine the added value of an individualized patient
management program in patients receiving Memantine.
All patients receive Memantine and follow-up evaluations
at no charge and are randomly assigned in a group receiving
compensation or a group receiving an individualized
program consisting of caregiver training and support as
well as home visits to get the patient exercising, doing
enjoyable activities and cognitive stimulation. For more
information, please contact Dr. Sunnie Kenowsky at 212-263-7164 or
sunnie.kenowsky@nyumc.org.
Other Studies and Programs
The Multicultural Program
Our Multicultural Aging and Memory Evaluation Program
offers a comprehensive, multidisciplinary evaluation
for elderly individuals with memory complaints or
symptoms of AD. The mission is to provide diagnostic
services to the ethnic minority and underserved populations,
to promote their access to the latest research programs,
and provide culturally- and language-appropriate
support services. For more information, contact Dorothy Patterson
at 212-263-3201, or Milena Perez at 212-263-1027 (Spanish).
Brain Donation Program
The NYU ADC team is very grateful to donors and
their families for participation in our Brain Donation
Program. Brain autopsy provides a definitive diagnosis
for families while contributing to important research on
the causes and treatment of brain aging and AD. Volunteers
with and without memory impairment are eligible.
For more information, contact Lynne Leung at 212-263-5108
or lynne.leung@nyumc.org.
Investigational Clinical Amyloid Research in
Alzheimer’s
Volunteers are being sought to participate in a clinical study
to evaluate the safety and effectiveness of an investigational
drug to help control the progression of Alzheimer’s disease.
Study participants will be randomized to investigational
product or placebo. For more information, please contact
George Marzloff at 212-241-1514. GCO #08-0241, 08-0242; MSSM approved
through 2/6/09.
Trial of a Nutritional Supplement in Alzheimer’s
Disease
A study investigating whether an antioxidant formula
containing resveratrol can help memory and thinking
of Alzheimer’s disease patients. Some study participants
will receive the formula (8 oz. of grape juice twice a day
with medication in it) and some will receive a placebo
(sugar pill). For more information, please contact Danielle Charney at
212-659-8883. GCO #05-1394; MSSM approved through 4/30/09.
Antipsychotic Discontinuation in Alzheimer’s Disease
This study examines the treatment of participants’ behavioral
and psychiatric symptoms (e.g., agitation, aggression,
pacing, paranoia, hallucinations) with risperidone, a medication
known to improve these symptoms. For more information,
please contact Andrew Vigario at 212-241-5692. GCO #06-0930;
MSSM approved through 8/31/09.
Functional Deficits of ACC in Mild Cognitive
Impairment
A new study is being conducted to examine the effects of
aging on memory and attention. Volunteers will be trained
for a simple computer task and will perform this task in an
MRI scanner. For more information, please contact Yunsoo Park at
212-241-7641. GCO #08-0443; MSSM approved through 6/19/09.
The Gammaglobulin Alzheimer’s Partnership Study
The Gammaglobulin Alzheimer’s Partnership (GAP)
Study is designed to evaluate the safety, efficacy, and tolerability
of the investigational drug Immune Globulin Intravenous
(IGIV) for the treatment of mild-to-moderate
Alzheimer’s disease. For more information, contact George Marzloff
at 212-241-1514. GCO #08-1326; MSSM approved through 3/16/10.
CONCERT: A Phase 3 Study Evaluating Dimebon in
Alzheimer’s Patients on Donepezil
Mount Sinai researchers will be participating in a Phase 3
study being conducted nationwide to evaluate how well
and how safe a study medication, Dimebon, is in combination
with donepezil (Aricept®) in patients diagnosed
with mild-to-moderate Alzheimer’s disease. For more information,
please contact Andrew Vigario at 212-241-5692, or via e-mail
at Andrew.Vigario@mssm.edu. GCO #09-0279; MSSM approved
through 3/23/10.
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. Men and women, with and
without memory impairment, are eligible to provide their
“intent” to consent for this program. For more information,
please contact Karen Dahlman, Ph.D. at 212-241-1844. GCO #84-119
and #79-141, MSSM IRB approved through 3/31/10.
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
Phase 1 trials: Small studies in healthy volunteers or patients that identify drug effects, measure side
effects of different doses, and explore efficacy.
Phase 2 trials: Larger studies in patients that evaluate efficacy and assess side effects.
Phase 3 trials: Large studies that build on earlier results and determine efficacy and safety; results form
basis for FDA approval.
Phase 4 trials: Post-approval studies that provide more information on risks, benefits, and optimal use.
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