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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 LY2062430 Administered by IV Infusion in Mild
to Moderate Alzheimer’s Disease
This is a Phase III study of LY2062430, an anti-amyloid
beta monoclonal antibody, administered by IV infusion.
Individuals with mild to moderate probable AD who are
55 years of age or older may be eligible to participate. For
more information, please contact Lynda Mules at 212-305-2077.
Study of ACC-001 Administered Subcutaneously 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 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. 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 Mild Cognitive Impairment
This is a study to evaluate an investigational medication
as a future potential treatment. Individuals with memory
loss or mild cognitive impairment (MCI) who are between
the ages of 45 and 90 may be eligible to participate. For more
information, please contact Evelyn Dominguez at 212-305-2371.
Metformin in Amnestic Mild Cognitive Impairment
This is a clinical trial of Metformin for the treatment of memory problems. Metformin is commonly used for the
treatment of diabetes. Men and women age 55 and older
who have memory complaints may be eligible to participate.
Participation will last 12 months. For more information,
please contact The Metformin-Memory study at 646-584-1166, 212-305-
4126 or 212-305-4730.
Antipsychotic Medication Treatment of Psychosis and
Behavioral Dyscontrol in Alzheimer’s Disease
This research study uses risperidone (an FDA-approved
antipsychotic medication) to treat people with Alzheimer’s
disease 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
more 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
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.
PET Scan Research Study for People with Alzheimer’s
Disease and Healthy Volunteers
This is a PET Scan study to see if an investigational PET
imaging compound could help improve detection, diagnosis
and treatment of Alzheimer’s disease in the future.
People at least 55 years of age and who are in good general
health with no memory problems OR have been recently
diagnosed with Alzheimer’s disease may be eligible to participate.
For more information, please contact Lynda Mules at 212-
305-2077 or lm2538@columbia.edu.
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 Brittany Holmes
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.
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 AD
An 18 month phase III “immunotherapy” study to test the
safety and effectiveness of Bapineuzumab, an experimental
antibody treatment that may reduce beta-amyloid, an
important toxic protein that contributes to development
of Alzheimer’s disease (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 information call Erica Epstein or Jessica Yunger at 212-
263-5845/5708.
Clinical Trial of Anti-Amyloid Antibody Treatment with
IGIV in Mild to Moderate AD
We are testing the safety and effectiveness of Intravenous
Immune Globulin (IGIV, Baxter) or placebo in participants
with mild to moderate AD. IGIV may interrupt the
processing of beta amyloid protein in the brain, which is
thought to play a role in the early pathology of AD. Participation
in this 18 month study involves regular visits,
repeated MRIs, and biweekly infusions both at NYU and
eventually in the participants’ homes. For information call Erica
Epstein or Jessica Yunger; 212-263-5845/5708.
Clinical Trial of Dimebon for Slowing the Progression
of
Alzheimer’s Disease
This trial is testing the effectiveness of Dimebon (a novel
antihistamine compound) as a potential treatment for AD.
Eligible participants diagnosed with mild to moderate AD
receive one of two doses of Dimebon or placebo for 12
months. Participation involves approximately ten visits
with repeated safety and memory evaluations. For information, call Erica Epstein or Jessica Yunger at 212-263-5845/5708.
Clinical Trial of CN156-018 in Mild Cognitive
Impairment (MCI)
This study will determine the possible effectiveness of
CN156-018 (an experimental gamma-secretase inhibitor)
versus placebo in patients with MCI over a 104 week treatment
period. The trial will compare disease progression
in the treatment and placebo groups measured by clinical
assessment scales, cerebrospinal fluid (CSF) and blood
biomarkers and volumetric MRI in MCI. For information call
Erica Epstein or Jessica Yunger at 212-263-5845/5708.
Clinical Trial of Anti-Amyloid Antibody LY2062430 in
Mild to
Moderate AD
This goal is to test the safety and effectiveness of intravenous
LY2062430 or placebo in participants with mild to
moderate AD. It is hoped that this treatment will interrupt
the processing of beta amyloid, a protein thought to
play an early role in the pathology of AD. Participation
involves regular visits to NYU with monthly infusions and
repeated MRIs. For more information, call Erica Epstein or Jessica
Yunger
at 212-263-5845/5708.
Early AD Diagnosis
Longitudinal Study of Normal Aging, Mild Cognitive
Impairment (MCI) and 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
information: Thet Oo at 212-263-8088; thet.oo@nyumc.org.
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, contact John Murray at 212-263-7795;
john.murray@nyumc.org or Megan Cummings 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-
50) 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.
Predictors of Decline in Normal Aging
This project investigates the relationship between plasma
amyloid levels and brain vascular response to CO2 (measured
with MRI). Additional tests include brain structure
measurement and CSF tau levels. Participants include mild
AD, MCI, and normal subjects who receive a comprehensive
evaluation consisting of a neurological/physical examination,
neuroimaging (MRI and ASL), memory testing,
laboratory blood-work, EKG and lumbar puncture.
Participants receive results and are compensated for their
time and effort. For more information, contact Kenneth Rich at 212-
263-7563; kenneth.rich@nyumc.org.
Alzheimer’s Disease Neuroimaging Initiative (ADNI)
This study is a multicenter project which looks at the usefulness
of imaging studies and biomarker tests, together
with measurements of memory, thinking and daily functioning,
in the future conduct of studies that will focus
on the identification and treatment of Alzheimer’s disease
at an early stage. This study aims to produce data to be
stored for these kinds of future research studies. We are
enrolling subjects ages 55-90. Participation involves magnetic
resonance imaging, positron emission tomography
study, lumbar puncture, as well as medical and cognitive
assessment. For information, contact Dr. Lidia Glodzik, 212-263-;
Lidia.Glodzik@nyumc.org.
Safety and efficacy of PET imaging with BAY 94-9172
(ZK6013443)
The goal is to test a method to detect early stages of AD,
which would improve diagnostic reliability and planning
for therapy. When AD begins, excess beta-amyloid protein
forms plaques in a certain part of the brain. The drug
ZK 6013443 is an F-18 tracer that binds to amyloid; with
PET, the distribution of amyloid in the brain can be measured. Participants over 55 with or without memory problems
receive an MRI, neurological/physical exams, memory
testing, a PET scan and laboratory blood work and are
compensated for their time and effort. For information: Megan
Cummings at (212)263-7795; megan.cummings@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 more information,
contact Ricardo Osorio; Ricardo.osorio@nyumc.org.
Effects of Memantine on the Magnetic Resonance
Spectroscopy (MRS) Measures of Neuronal Integrity in
Subjects at Risk for Alzheimer’s Disease
The purpose of this study is to examine the effects of
Memantine also known as NAMENDATM (a drug currently
approved for the treatment of moderate to severe
Alzheimer’s disease (AD)), on the brain of people who
are healthy but have subjective complaints about their
memory. The effects of the drug will be measured using a
brain scan. Three brain scans are planned: at the beginning
of the study, after 4 months and after 6 months. Results
of these tests will help to determine whether Memantine
changes the amounts of chemical substances that make up
the brain. For information, contact Dr. Lidia Glodzik, 212-263-; Lidia. Glodzik@nyumc.org.
Helping Caregivers
Early Stage Support Group Evaluation
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 information, call Ursula
Auclair at 212-263-2245.
Memantine (Namenda) and Individualized Alzheimer’s
Care
The goal of this 6-month to 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 more information, contact
Sunnie Kenowsky at 212-263-7164; sunnie.kenowsky@nyumc.org.
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.
Nerve Growth Factor (NGF) Study (GCO #09-0367)
CERE-110 is research drug being used in gene therapy
research for Alzheimer’s disease (AD). In this study genes
are transferred to brain cells via neurosurgery so that the
body can make NGF, a naturally occurring protein that
might increase the survival of neurons that die in AD. The
purpose of this phase 2 clinical trial is to find out if this
type of gene therapy technique, neurosurgically injecting
CERE-110, is safe, well-tolerated, and of benefit when
given to people with AD. For more information, please contact
Judy Creighton, M.A., at 212-659-8885. MSSM #09-0367; Principal Investigator:
Judith Neugroschl, M.D. MSSM approved through 4/13/11.
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 god 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 George
Marzloff at (212) 241-1415. MSSM #10-0329; Principal Investigator: Hillel
Grossman, M.D. MSSM approved through 3/29/11.
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 (AD). This research
study will work to evaluate whether Dimebon may
improve both the function and outgrowth of brain cells,
which is often compromised in a number of neurodegenerative
diseases such as AD. Further, the study will evaluate
whether Dimebon could provide improvements in cognition
and activities of daily living when given in combination
with donepezil. Study participants will receive active
study drug or placebo (inactive pill) for 12 months for the
duration of the study, while continuing to take the prescribed
donepezil. All participants will be carefully monitored
at the research clinic throughout the study, and will
be compensated for transportation to and from the clinic.
Participants are eligible to participate if they meet the following
criteria: are 50 years of age or older and have mildto-
moderate AD; have a Mini-Mental State Examination
(MMSE) score of 12-24, inclusive; have a brain computed
tomography (CT) or magnetic resonance imaging (MRI)
scan consistent with a diagnosis of probable AD within 12
months prior; have been taking donepezil for at least six
months, with stable dosing at 10mg/day for at least the
last four months; have a caregiver who is able to attend all
study visits. For more information, please contact Andrew Vigario at
(212) 241-5692, or via email at Andrew.Vigario@mssm.edu. MSSM
#09-0279; Principal Investigator: Hillel Grossman, M.D. MSSM approved
through 3/23/10.
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 (AD). IGIV is a biologic agent with
anti-inflammatory and immunomodulating properties;
this study is being conducted to determine if IGIV can
help slow the progression of AD and its symptoms. The
Gammaglobulin Alzheimer’s Partnership (GAP) Study is
seeking volunteers who: 1. Are aged 50-89, and who have
probable mild-to-moderate AD. 2. Have a Mini-Mental
Status Exam (MMSE) score of 16-26. 3. Have not suffered
from serious or unstable diseases within the past 3 months.
4. Have a study partner who can actively participate in the
study with the volunteer. For more information, please contact
George Marzloff at (212) 241-1514, or via email at george.marzloff@ mssm.edu. MSSM #08-1326; Principle Investigator: Hillel Grossman,
M.D. MSSM approved through 3/16/10.
Functional Deficits of ACC in MCI
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. All participants will be compensated
for time and travel. Participants are eligible to participate
if they meet the following criteria: 1. are between
55 - 90 years of age, 2. are either free of memory problems
or are experiencing some memory problems, 3. have a
Mini-Mental Status Exam (MMSE) score higher than 24
(if not known, this can be determined through evaluation),
4. have no metal in their body, 5. do not have any
current psychiatric disorders, 6. are not claustrophobic. For
more information, please contact Yunsoo Park, Clinical Research Coordinator
at the Mount Sinai Lab of Neuroimaging by phone at (212) 241-
1613, or via email at yunsoo.park@mssm.edu. MSSM GCO #08-0443
IRB approved through 6/19/10.
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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