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Clinical Trials  

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.



Alzheimer's Association

Our vision is a world without Alzheimer's
Formed in 1980, the Alzheimer's Association is the world's leading voluntary health organization in Alzheimer's care, support and research.