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Clinical Trials  

Jump To: Columbia University Clinical Trials↓   
              NYU School of Medicine
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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 973-943-6706 or mm2626@columbia.edu.

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.

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


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 Dana Pogorelec or Alex Sierra at 212- 263-5845/5708 or email alex.sierra@nycmc.org

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 Alex Sierra at 212- 263-5845/5708 or email alex.sierra@nycmc.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 information, call Sunnie Kenowsky at 212-263-7164; sunnie.kenowsky@nyumc.org

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- 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.

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.

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.

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.

Rivastigmine prophylaxis for elderly patients at risk for delirium: A randomized, double blind placebo-controlled pilot study
The goal of this study is to assess the effectiveness of Rivastigmine, a long central acting acetylcholinesterase inhibitor commonly used to slow the progression of Alzheimer’s and other dementias, on the prevention of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in an elderly population undergoing surgery. POD is characterized by changes in consciousness and cognition over a brief period of time. POCD refers to cognitive problems involving memory, learning and the ability to concentrate observed weeks or months after surgery. We are enrolling subjects over age 65 who will receive a brief series of evaluations of their cognitive and memory function. For information, contact Andrew Sapson, MD at 212-263-0667.







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 Priyanka Ghosh at 212-659-8885; priyanka.ghosh@mssm.edu. #09-0367; Principal Investigator: Judith Neugroschl, M.D. MSSM.

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 Aliza Romirowsky at (212) 241-1415; aliza.romirowsky@mssm.edu. MSSM #10-0329; Principal Investigator: Hillel Grossman, M.D. MSSM approved through 3/29/12.

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 Priyanka Gosh at (212) 659-8885, or via email at priyanka.gosh@mssm.edu. MSSM #08-1326; Principle Investigator: Hillel Grossman, M.D. MSSM approved through 3/16/12.

Trial of NIC5-15, a Natural Product in Subjects with Alzheimer’s Disease. We are seeking Veterans with Alzheimer’s disease to participate in a research study of a natural product, NIC5-15 at the BronxJames J. Peters Veterans Medical Center. NIC5-15 is a natural product found in legumes and soybeans. In laboratory studies it interferes with the accumulation of a protein in the brain that is involved in the development of Alzheimer’s disease. Researchers hypothesize that this may slow down the progression of the disease. Some study participants will receive NIC5-15 and some will receive a placebo (sugar pill). Participation in the study includes physical exams, neurological exams, blood tests and tests of memory and thinking skills. Participation of 8 months is necessary. For more information please contact Riana Moring-Parris at 718-584-9000 ext 5179, or email at Riana.moring-parris@mssm.edu. Principal investigator: Hillel Grossman, MD. VA GRO#10-029 MSSM approved12/6/2010-6/30/2011.



Alzheimer's Association

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