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Treatment Studies
Clinical Trial of Anti-Amyloid Antibody
Bapineuzumab in
Mild to Moderate Alzheimer’s
Disease (AD)
We are currently enrolling participants for a clinical trial that involves an “immunotherapy” treatment approach. This phase III study (Elan/Wyeth) tests the safety and effectiveness of Bapineuzumab, an experimental antibody treatment that may remove or reduce beta-amyloid, which is one of the important toxic proteins that contribute to the development of Alzheimer’s disease (AD). It is hoped that this treatment may slow the further progression of the disease. This study is enrolling patients with mild to moderate AD who will receive one of three doses of either the experimental drug or two for up to 18 months. Study participation involves intravenous infusion of study drug, periodic visits to the study center, as well as repeated MRI scans. To receive more information about this study, please call Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.
Clinical Trial of Gamma-Secretase Inhibition for
Slowing
Progression of Alzheimer’s Disease (AD)
This trial is testing the effectiveness of a gamma secretase inhibitor compound (Lilly LY450139) in reducing the production of beta-amyloid, thereby possibly slowing the rate of disease progression. Eligible participants with mild to moderate AD will receive either experimental drug or placebo for 23 months. All participants in the study, whether on active drug or placebo, will eventually receive the experimental drug for the latter half of the trial. For more information, please call Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.
Clinical Trial of Anti-Amyloid Antibody Treatment
with IGIV
in Patients with Mild to Moderate
Alzheimer’s Disease (AD)
This trial is testing the safety and effectiveness of Intravenous Immune Globulin (IGIV, Baxter) or placebo in participants with mild to moderate Alzheimer’s disease (AD). It is hoped that this treatment will interrupt the processing of a protein in the brain, beta amyloid, which is thought to play an early role in the pathology of AD. This study will enroll patients with mild to moderate AD. Study participation involves regular visits to the hospital, repeated MRIs, and biweekly infusions both at NYU and eventually in the participants’ homes over 18 months. To receive more information about this study, please call Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.
Clinical Trial of Dimebon for Slowing the Progression
of Alzheimer’s Disease (AD)
This trial is testing the effectiveness of a novel antihistamine compound (Dimebon) as a potential treatment of mild to moderate Alzheimer’s Disease. Eligible participants who are diagnosed with AD will receive one of two doses of Dimebon or placebo for 12 months. Study participation involves approximately ten visits to the study center over twelve months with repeated safety and memory evaluations. For more information, please call Erica Maya or Jessica Lerer at 212-263-5845 or 212-263-5708.
Upcoming Clinical Trials
We will soon be seeking to enroll participants in two new
trials involving anti-amyloid investigational drugs, one
administered intravenously to AD patients and another
orally to MCI patients.
Early Ad Diagnosis
Longitudinal Study of Normal Aging, Mild Cognitive
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 more information, please contact Emma Shulman, CSW at 212-263-5756 or Thet Oo, M.D. at 212-263-8088; thet.oo@nyumc.org.
Positron Emission Tomography (PET) and Memory Study
This NIH-funded program uses advanced brain imaging techniques to measure the metabolic function of the brain so as to predict future cognitive impairment. This longitudinal imaging study of elderly individuals uses a new amyloid imaging scan and a proven glucose metabolism scan to better understand the differences between successful aging and the progression to memory impairment and to Alzheimer’s disease. We are developing and testing a profile of measures to identify those at increased risk for future memory impairment. Study recruitment includes individuals between 40-90 years with and without memory problems. For more information, please call Schantel Williams at 212-263-7563.
Cerebral Spinal Fluid (CSF) Study
This study seeks to develop a specific early AD diagnosis based on analysis of cerebrospinal fluid. This NIH supported project evaluates whether the amount and type of amyloid and tau proteins (proteins associated with AD) and isoprostanes (markers of oxidative stress) that are found in the CSF are related to memory changes and the brain shrinkage seen in MRI studies. These markers may be useful to screen early AD and to potentially follow progression and track response to treatment. Participants include normal individuals over 40 years of age, individuals with memory problems, mild cognitive impairment and AD. For more information, call Dr. Kenneth Rich at 212-263-7563.
PET-Amyloid Diagnostic Clinical Trial
The goal is to test a new method (Bayer Healthcare) for earlier/more effective detection of Alzheimer’s disease (AD). Improved early diagnosis will facilitate early treatment and differentiation from other illnesses. We know that when AD begins, a protein (beta-amyloid) forms plaques in certain parts of the brain. Since the drug ZK 6013443 binds to this protein, it is made radioactive and used as a tracer with an imaging method called positron emission tomography (PET). This method provides brain images showing whether there is amyloid in the brain. We are looking for healthy individuals over the age of 55 without memory problems. PET-ZK 6013443 results from this group will be compared to results from individuals who have a diagnosis of AD. For more information please contact Marla Guzman at (212)263-7563
FDG-PET Study on Family History of Alzheimer’s
Disease (AD)
Researchers at the Center for Brain Health recently discovered that children of mothers with Alzheimer's disease (AD) appear to be predisposed to reductions in brain glucose metabolism. These individuals may also be at increased risk for developing AD, as compared to children of AD fathers and children of parents without AD. This NIH/NIA funded study is recruiting cognitively normal individuals ages 25-85 with either a maternal or paternal family history of AD to participate, as well as individuals with no family history. The project involves measuring brain activity using a neuroimaging technique called positron emission tomography (PET). The PET scan utilizes a tracer called fluorodeoxyglucose (FDG), which allows the measurement of brain glucose metabolism. We will also measure proteins from blood that indicate mitochondrial activity, since altered activity of these proteins may cause increased oxidative stress and possibly increase risk for AD. Participants receive a comprehensive medical exam and also are offered medical, lifestyle and risk consultation. For more information, contact Dr. Lisa Mosconi at lisa.mosconi@med.nyu.edu or Rachel Mistur at rachel.mistur@med.nyu.edu. You can also reach us at 212-263-7563.
Helping Caregivers
Counseling and Support for People Caring for a
Parent
with Alzheimer’s Disease (AD)
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 Alzheimer’s disease. 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. Based on an earlier program, we expect that all participants will experience significant benefits to their well-being, including reduced stress and depression and postponed nursing home placement of their parents. If you are the ‘primary’ caregiver of the person with a diagnosis of dementia (i.e., the first person called if the patient is in need of help) and a daughter, son, daughter-in-law, or son-in-law of the person with AD and would like more information, please contact Olanta Barton
at 212-263-5710 or olanta.barton@nyumc.org.
Early Stage Support Group Evaluation of Outcomes
Common concerns for people with mild AD include responses to receiving the diagnosis, disclosing the diagnosis to others, developing coping strategies for cognitive and functional loss and finding meaningful activities. 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 more information, please call Ursula Auclair, LCSW
at 212-263-2245.
Memantine (Namenda™) and Individualized
Alzheimer’s Care
Are you caring for someone who is in the middle or late stage of Alzheimer’s? Would you like to see them function and feel better? Would you like to solve the empty day syndrome? The goal of this study is to determine the added value of an individualized patient management program in AD patients receiving Memantine. Subjects with moderate to severe AD are eligible. All patients receive Memantine and follow-up evaluations at no charge. In addition, patients are randomly assigned to one of two groups. One group receives compensation and the other receives 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. The study duration is one year. For more information, please contact Dr. Sunnie Kenowsky at 212-263-7164 or sunnie.kenowsky@nyumc.org.
Other Studies and Programs
The Multicultural Program
Our Multicultural Aging and Memory Evaluation Program offers a comprehensive, multidisciplinary evaluation for elderly individuals who present with memory complaints or symptoms of dementia or Alzheimer’s disease. The mission of this program is to provide diagnostic services to the ethnic minority and underserved populations, to promote their access to early utilization of these services and to the latest research programs, and provide culturally and language-appropriate support services. For more information, please contact Dorothy Patterson at 212-263-3201, or Milena Perez at 212-263-1027 to discuss in Spanish.
Brain Donation Program
The NYU ADC team is very 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. Volunteers with and without memory impairment are eligible for participation in this program. For more information, contact Lynne Leung at 212-263-5108 or lynne.leung@nyumc.org.
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