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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 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 Memantine in Frontotemporal Dementia
This is a Phase IV research study to determine if memantine
is effective in slowing the rate of behavioral decline
in frontotemporal dementia. English-speaking men and
women who are 40 to 80 years old and who have been diagnosed
with frontotemporal dementia (FTD) or semantic
dementia (SD) may be eligible. For more information, please
contact Lynda Mules at 212-305-2077.
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 BMS-708163 in Mild Cognitive
Impairment (MCI)
This study will determine the possible effectiveness of
BMS-708163 (an experimental gamma-secretase inhibitor)
versus placebo in patients with MCI over a 24 week treatment
period and a follow-up period of an additional 28
weeks. The follow-up period will provide 1-year observational
data to 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 information,
contact John Murray at 212-263-7795; john.murray@nyumc.org.
Family History of Alzheimer’s Disease: Hypometabolism
and
Oxidative Stress
This goal is to determine if individuals with a maternal
history of AD exhibit brain metabolic patterns consistent
with AD and if this pattern is related to cell oxidation. We are enrolling normal participants with and without a
family history of AD who receive a comprehensive evaluation
including a neurological/physical examination, neuroimaging
(MRI and PET), memory testing, laboratory
blood-work and EKG. Participants receive results and are
compensated for their time and effort. For 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.
Measuring Neural STE M Cells with Magnetic
Resonance Spectroscopy in Aging and AD
We are investigating if a signal from neural progenitor
cells can be detected with Magnetic Resonance Spectroscopy
(MRS), and if it differs between normal individuals
(with and without memory complaints} and patients with
mild AD. Participants receive a comprehensive evaluation
consisting of a neurological/physical examination, MRI,
memory testing, laboratory blood-work, EKG and lumbar
puncture. Participants receive results and are compensated
for their time and effort. For information, contact Fahad Ali at
212-263-7563; fahad.ali@nyumc.org.
Amyloid in Lens of Eye: Neuroptix Study
We are recruiting normal individuals and patients with
mild AD to help develop an early screen for AD involving
visualizing amyloid protein in the lens of the eye. This
project assesses whether a new technique to detect amyloid
in the lens has diagnostic value. Participants receive a complete
neurological evaluation, MRI and LP, and are compensated
for their time and effort. For more information, contact
the Anna Hemraj at 212-263-1091; bhanmatie.hemraj@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/Marla Guzman
at (212)263-7563; megan.cummings@nyumc.org; marla.Guzman@nyumc.org.
Helping Caregivers
Counseling and Support for People Caring for a Parent
with
Alzheimer’s Disease
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: Olanta Barton at 212-263-
5710; olanta.barton@nyumc.org.
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.
Patient and Caregiver Registry for AD patients in the
Community Setting
The purpose is to test a new caregiver assessment of burden
and well-being of dementia patients. Caregivers of dementia
patients are eligible if the patient lives in the community,
and the caregiver has at least 2 hours per week of face-toface
interaction the patient and knows his or her daily routine.
The patient must be receiving 1-2 drugs for dementia.
Caregivers will be asked to provide information about their own medical history and healthcare resource utilization
every 3 months and will be reimbursed for participation.
Contact Olanta Barton at 212-263-5710; olanta.barton@nyumc.org.
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 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.
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 e-mail 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 e-mail
at george.marzloff@mssm.edu. MSSM #08-1326; Principle Investigator: Hillel Grossman,
M.D. MSSM approved through 3/16/10.
Investigational Clinical Amyloid Research in
Alzheimer’s
We’re looking for volunteers 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 the
investigational product or placebo (a treatment with no
active ingredient). There is a 60% chance of receiving the
investigational drug and a 40% chance of receiving a placebo.
Study participants will be asked to attend 15 study
visits during an 83-week period, receive six infusions of
the investigational drug every 13 weeks for 65 weeks, and
have blood tests and study-related physical and clinical exams.
Study participants may be eligible if they are between 50-85 years of age, have a diagnosis of probably AD, and
have a caregiver who is willing to be involved in the study.
For more information, please call George Marzloff at (212) 241-1514, or
e-mail at George.Marzloff@mssm.edu. MSSM #08-0241, 08-0242;
Principal Investigator: Hillel Grossman, M.D. MSSM approved through
3/23/10.
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 e-mail at yunsoo.park@mssm.edu. MSSM GCO #08-00443 IRB
approved through 6/19/10.
Antipsychotic Discontinuation in Alzheimer’s Disease
We are looking for volunteers to participate in a research
study that uses risperidone, which is an FDA-approved
antipsychotic drug, in the current study as an experimental
treatment for people with Alzheimer’s disease (AD), who
suffer from hallucinations, delusions, agitation and/or aggression.
Risperidone is not a treatment for memory difficulties,
but rather is being studied in this trial to see if it
will improve behavioral difficulties associated with AD.
This study continues over a period of 48 weeks. All participants
will be carefully monitored at the research clinic
throughout the study. Participants are eligible to participate
if they are between 40-95 years of age, have a diagnosis
of probable AD, have a Mini-Mental State Examination
(MMSE) score between 5-26 (at the time of the screening
visit), and have a caregiver who is able to attend all study
visits. For more information, please contact Andrew Vigario at (212)
241-5692, or via e-mail at andrew.vigario@mssm.edu. MSSM #06-
0930; Principle Investigator: Corbett Schimming, M.D. MSSM approved
through 8/31/10.
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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