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Jump To: Columbia University Clinical Trials↓
NYU School of Medicine↓
Mt. Sinai School of Medicine↓
Treatment Studies
The Gammaglobulin Alzheimer’s Partnership Study
(GAP)
This is a Phase III study of intravenous immunoglobulin
(“IGIV”) in mild to moderate AD. Men and women age
50 to 85 with mild to moderate AD may be eligible to
participate. For more information, please contact Ruth Tejeda at 212-
305-7661 or rbt41@columbia.edu.
Study of ACC-001 Administered by Intramuscular Injection in Alzheimer's Disease
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 Davunetide for the
Treatment of Progressive
Supranuclear Palsy
This is a
Phase 2/3 study of davunetide
administered by nasal spray. People
with Progressive Supranuclear Palsy
who are 41 to 85 years old may
be eligible to participate. For more
information, please contact Lynda Mules
at 212-305-2077.
Study of Tolcapone for
Frontotemporal Dementia
This study will test if a medication
called tolcapone (Tasmar) can
improve the symptoms of
frontotemporal dementia (FTD).
It will also test the utility of a
type of brain scan called fMRI
for detecting changes that occur
in the brain when a medication
reduces symptoms and the effect
of a common genetic variant on
the symptoms of FTD. Men and
women who have been diagnosed
with FTD and are 40 to 85 years old
may be eligible to participate. For
more information, please call Masood
Manoochehri at 973-843-6706 or
mm2626@columbia.edu.
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.
Treatment Study for Agitation
and/or Aggression in
Alzheimer’s Disease This is
a research study, funded by the NIH, for
people ages 50-99 who have Alzheimer’s
Disease and also have symptoms of agitation
and/or aggression. The study includes medical
evaluation by physicians who specialize
in memory disorders and treatment with
medication. Each eligible participant must
have a family member or caregiver who can provide information during the research
study. Please call Sarah Farkas at 212-543-
6132 for more information.
Other Studies
Alzheimer’s Disease
Neuroimaging Initiative
The
purpose of this study is to determine if
brain imaging can help predict the onset
and monitor the progression of Alzheimer’s
disease. The study will also use lumbar
punctures and blood draws to determine
if biomarkers can predict and monitor the
disease. English and Spanish speaking eople
with memory complaints who are in good
general health and between the ages of 55
and 90 may be eligible to participate. Please
contact Philip Yeung at (212) 342-0522 for
more information.
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, and participants
will be compensated. Please contact Abbey Frawley
at
212-305-7846 for more information.
Memory and Self Awareness Study
This is a study about how people evaluate their own memory
abilities, and how self-awareness influences important
issues such as everyday decision making and quality of life.
Individuals with mild AD are eligible to participate and
will be compensated. Please contact Dr. Stephanie Cosentino
at
(212) 342-0289 for more information.
African American Genetics
Study
This study for people over the
age of 60 looks at genetic risk factors
for Alzheimer’s disease among African
Americans. The study involves an
interview to include memory and
thinking tests, questions about your
health and experiences, and a blood
draw. For more information, call Josina
Hector at 212-305-1893.
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.
Research Opportunities
Longitudinal Study of Normal
Aging, Mild Cognitive Impairment
(MCI) and Alzheimer’s Disease
Participants receive a comprehensive
diagnostic evaluation and are reevaluated
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 information, call Thet Oo
at 212-263-8088; thet.oo@nyumc.org
TREATMENT STUDIES
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 and are
randomly assigned to 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 information,
call Sunnie Kenowsky at 212-263-7164;
sunnie.kenowsky@nyumc.org
Rivastigmine prophylaxis for
elderly patients at risk for
delirium:
A randomized, double
blind placebo-controlled pilot
study
The goal is to assess the
effectiveness of Rivastigmine, a long
central acting acetylcholinesterase
inhibitor commonly used to treat
AD and other dementias, on the prevention of postoperative delirium
(POD-changes in consciousness
and cognition over a brief period of
time ) and postoperative cognitive
dysfunction (POCD-cognitive
problems involving memory, learning
and the ability to concentrate
observed weeks or months after
surgery) in an elderly population
undergoing surgery. Subjects over
age 65 will receive a brief series of
evaluations of their cognitive and
memory function. For information,
contact Andrew Sapson, MD at 212-
263-0667.
Early AD Diagnosis
Clinical Correlates of Longitudinal PET Changes in
Alzheimer’s Disease
The goal is to assess combining FDG-PET imaging (brain
metabolism) with cerebrospinal fluid (CSF) biomarkers and
PET amyloid imaging (using a tracer that binds to brain
amyloid) in predicting cognitive decline. We are enrolling
mild AD, MCI and normal subjects over age 20 who receive
a comprehensive evaluation: neurological/physical exam,
MRI and PET, memory testing, laboratory blood-work,
EKG and lumbar puncture. Participants receive results and
are compensated for their time and effort. For more information, call Alex Sierra at 212-263-7795; megan.cummings@nyumc.org.
Maternal History of Alzheimer Predisposes Children to
Brain Hypometabolism
The goal is to determine whether young subjects (age 20-
60) with maternal family history of AD show reductions
in the brain’s ability to use sugar, and to see if there are
greater reductions in subjects with family history spanning
2 generations (i.e., mother and grandmother affected with
AD). For more information, contact John Murray at 212-263-7795;
john.murray@nyumc.org.
Effects of Memantine
on Magnetic Resonance
Spectroscopy in persons at
risk for AD
This study is for adults
55-90 with memory complaints and
a family history of AD, but without
any signs of memory decline. We are
testing whether Memantine, a drug
approved for the treatment of moderate
to severe AD, may be beneficial
in these at risk individuals. The study
duration is 6 months. The brain effects
of memantine are measured with
magnetic resonance spectroscopy
(MRS), a scan to investigate in the
chemical substances that make up
the brain. For information, call Lidia
Glodzik at 212-263-5698;
lidia.glodzik@nyumc.org.
Imaging Neuroinflammation
in Alzheimer’s Disease with
[11C]Arachidonic Acid (AA)
and PET
The goal is to validate a
new inflammation PET imaging agent
known as [11C] Arachidonic Acid
(AA) in individuals with and without
cognitive dysfunction. Inflammation
is a key component of the pathological
processes (amyloid beta plaque
deposition, neurofibrillary tangles,
neuronal loss, astrocytosis) that are
found in patients with Alzheimer
disease (AD). An in vivo neuroimaging
method to measure markers of
neuroinflammation would represent
a major advance in the understanding
of the pathophysiology of AD and
other dementing disorders. We are
enrolling normal and dementia
subjects over the age of 65 who receive
physical examination, blood tests,
neuropsychological evaluation, EKG,
MRI; [11C]PIB, [18F]FDG, and [11C]
AA PET scans. Participants receive
results and are compensated for their
time and effort. For information,
contact Ricardo Osorio at 212-263-3258; Ricardo.osorio@nyumc.org.
MRI Progression Markers
of Cognitive Decline in the
Elderly
This project investigates the
relationship between plasma amyloid
beta protein levels and brain vascular
response to CO2 (measured with
MRI). Additional tests include brain
structure measurement and CSF tau
levels. Participants should have mild
cognitive impairment (MCI), and will
receive a comprehensive evaluation
consisting of a neurological/physical
examination, neuroimaging (MRI
and ASL), memory testing, laboratory
blood-work, ECG and lumbar
puncture. Participants receive results and are compensated for their time
and effort. For information, contact
Vanessa Bikhazi at 212- 263-7563;
vanessa.bikhazi@nyumc.org.
Biomarkers in Early
Alzheimer’s Disease
This
project builds upon on our new work
demonstrating the value of cerebrospinal
fluid (CSF) and blood biomarkers.
We combined these analyses with
novel MRI technology which looks
at cerebral blood flow, a possible
mechanism-based marker for early
Alzheimer’s disease. We are enrolling
normal subjects over the age of age
50, with and without mild memory
complaints to receive a comprehensive
evaluation: neurological/physical
exam, MRI and memory testing,
laboratory blood-work, EKG and
lumbar puncture. Participants receive
results and are compensated for their
time and effort. For information,
contact Vanessa Bikhazi at 212-263-
7563; vanessa.bikhazi@nyumc.org.
Aß42 CSF changes in elders
with sleep disorders. A new
risk factor for AD?
Sleep is
involved in brain restoration and
modulation of memory. The goal
of our study is to analyze if the
production of amyloid is disrupted by
sleep/wake changes that occur during
normal aging, and exacerbated in
older subjects with sleep disorders,
increasing the risk for developing AD.
For this purpose, we plan to conduct
clinical examinations, objective evaluation
of sleep duration and quality
using an actigraph, sleep breathing
using and ARES Unicorder and CSF
measurements. We are enrolling
cognitively normal subjects ages
60-85 with chronic sleep disorders
and subjects with normal sleep. This
project will provide us with very useful
information about Aß metabolism
in the elderly and of certain patterns
of sleep disorders as potential risks
factors for developing AD. This finding,
given the effect of sleep disorders
in our lives, the increasing numbers
of cognitively impaired elders, and the
fact that millions of people regularly
obtain insufficient sleep, would be of
the highest relevance. For information, contact Ricardo Osorio at 212-263-
3258; Ricardo.osorio@nyumc.org.
Postoperative cognitive decline, inflammation, and plasma levels of betaamyloids
The goal of this study is to examine whether inflammation associated with surgery may increase the risk of postoperative cognitive dysfunction (POCD) in elderly patients who already have a degree of preoperative mild cognitive impairment (MCI). Inflammatory mechanisms may also be involved with the progression of Alzheimer’s Disease. POCD is a potential complication that may have consequence for patients’ quality of life. This is the first prospective study to attempt to establish this link. We are enrolling MCI and normal subjects over age 65 who receive a series of comprehensive evaluations of cognitive and memory functioning as well as laboratory blood-work. Timing is important so please let us know if you are planning to have surgery. Participants are compensated for their time and effort. For information, contact Sonya Farber, MA at 212-263-0531.
Other Studies and Programs
The Multicultural Program
The 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 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 is 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. Donors with and without
memory impairment are eligible. Contact Lynne Leung at 212-
263-5108; lynne.leung@nyumc.org.
Early Stage Support
Group
The center offers facilitated
support group meetings to people in
the early stages of AD. 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 information,
call Ursula Auclair at 212-263-2245.
Support for Caregivers
A peer
facilitated support group for caregivers
conveniently meets at the same time as
the early stage AD support group held
on Thursday’s. If interested, please call
Ursula Auclair, LCSW at 212 263-2245.
Nerve Growth Factor (NGF) Study (GCO #09-0367)
Mount Sinai researchers
will be participating in a phase 2
clinical trial that is being conducted
nationwide. This study will evaluate
whether a type of gene therapy
technique is safe, well-tolerated, and
of benefit to people with Alzheimer’s
Disease (AD). In this clinical trial, a
study drug named CERE-110 will
be injected into an area of the brain
affected by AD so that the body can
make nerve growth factor (NGF).
NGF is a naturally occurring protein
that may increase the survival of
neurons that die in AD. In this study,
half of the participants will receive
CERE-110 via neurosurgery and
the other half will receive a placebo
procedure. Participation will also
include a medical examination and
cognitive testing. All participants
will be carefully monitored by a
team of physicians for two years.
In addition, all participants will be
asked if they want to participate in
a separate, open-ended protocol for
further clinical observation. This
study is open to eligible individuals
with mild AD between the ages 55
and 80, who are in good general
health, and are able to undergo
surgery. If you would like information
about this study, please contact Priyanka
Ghosh at 212-659-8885 or priyanka.
ghosh@mssm.edu.
Neuroimaging in Head Injury and
Cognitive Decline
This is a study
investigating brain and memory
and thinking problems associated
with having a history of concussion
or mild traumatic brain injury
(TBI) in a sample of individuals
between the ages of 35 and 60. We
are investigating whether having a
history of concussion or mild TBI
with and without mild cognitive
impairment (MCI) is distinct by
using MRI and tests of memory
and thinking. We are looking for
participants with either a history
of concussion/mild TBI and
MCI or a history of TBI without
MCI. Participants must be English
speakers. Participants will receive
compensation for their time. For
more information, please contact Elisheva
Bellin at 212-241-5290, or via email
at Elisheva.Bellin@mssm.edu. MSSM
#10-0954; Principle Investigator: Effie
M. Mitsis, PhD MSSM approved
through 1/24/13.
Alzheimer’s Disease
Neuroimaging Initiative – Grand
Opportunity (ADNI-GO)
In this
study, we hope to determine whether imaging of the brain
through MRI, PET and amyloid
imaging scans can help predict and
monitor the onset and progression
of Alzheimer’s disease. In addition to
neuroimaging, the study will collect
and test blood and cerebral spinal
fluid to determine if biomarkers can
predict and monitor the disease. This
study is sponsored by the National
Institutes of Health and will take
place at about 50 major universities
across the US and Canada. No
study drug is used in this research.
Participants cannot be involved in
other clinical trials while in this
study. This is a longitudinal study
which will span several years. We
are looking for volunteers who can
participate for the full duration.
The study needs volunteers who:
are between 55 and 90 years of age,
in good health but have memory
problems and concerns, are fluent in
English or Spanish, are willing and
able to undergo the test procedures,
and have a study partner – a friend
or relative who can accompany
the volunteer to all clinic visits.
Participant’s health will be closely
monitored by a team of doctors
and nurses. Participants will receive
compensation for their time and
costs incurred for travel, parking
and meals. For more information,
please contact Aliza Romirowsky at
212-241-1514. MSSM #10-0329;
Principal Investigator: Hillel Grossman,
M.D. MSSM approved through
3/29/12.
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