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Mount Sinai School of Medicine • Clinical Trials

RAGE Study

Researchers are participating in a nationwide study that will test an experimental treatment, RAGE Inhibitor, to target the source of Alzheimer’s disease (AD). One of the proteins that surround the amyloid plaques in AD patients, called receptor for Advanced Glycation Endpoints (RAGE for short) binds to amyloid and may promote nerve cell damage. By inhibiting the RAGE protein, plaque formation could be reduced. Volunteers will receive either active study drug or placebo (inactive pill). All participants will be monitored carefully at the research clinic throughout the study. Participants are eligible to participate if they are age 50 or older and have mild-to-moderate AD, have not had any serious or unstable diseases within the past three months, do not have Type 1 or Type 2 diabetes and have a reliable caregiver who can accompany them to all study visits. For more detailed information please contact Tessa Lundquist at 212-659-8885 or Tessa.lundquist@mssm.edu. MSSM GCO 08-0194 IRB approved thru 5/12/2009

 

A Home-Based Assessment (HBA) Study for Memory Protection Research

We are seeking healthy volunteers, 75 or older, to participate in a nationwide research study to examine methods to evaluate memory and thinking skills from the home. Currently, in order to participate in Alzheimer’s disease research studies, volunteers must visit a clinic to meet with researchers. The Home-Based Assessment study will look at three types of home evaluation methods — a telephone, electronic kiosk or mail-in forms — to determine if there may be a better way to gather study information and track memory and thinking-related changes over time. Participants will be assigned by chance to one of the three methods and their memory and thinking skills will be evaluated using their particular method monthly, quarterly or annually. Participants will also have an in-person screening evaluation visit that will include a physical and neurological exam, a medical history, and some cognitive testing. Participants will also be given a multi-vitamin to be taken twice daily, as the study will examine how well the different methods report pill-taking behavior. At the end of the 4-year study, participants will undergo a final in-person evaluation. For more information, please contact
Jessica Egan at 212-241-8329. GCO#91-208 (13);
Principal Investigator: Jane Martin, Ph.D., MSSM IRB approved through 08/31/2009.

 

A Trial of a Nutritional Supplement in Alzheimer’s Disease (AD)

We are seeking patients with AD to participate in a research study on an antioxidant formula containing resveratrol. Some study participants will receive the formula and some will receive a placebo (sugar pill). Participation in the study includes memory testing, neurological exams, and blood tests. Resveratrol may reduce brain cell damage caused by harmful chemical byproducts. This study is investigating if resveratrol can help the cognition of AD patients. The study will be conducted over 12 months and is funded by the Alzheimer’s Association. For more information, please contact our ADRC research coordinator at 212-241-8329. GCO #05-1394(0001),
Principal Investigator: Mary Sano, Ph.D., MSSM IRB approved through 4/30/09.

 

The Development of NIC5-15 in the Treatment of Alzheimer’s Disease (AD)

We are seeking patients with AD to participate in this randomized, double-blind, placebo-controlled trial of a dietary supplement. This supplement has anti-diabetic effects in people and has been shown to improve memory in laboratory animals. It also reduces the production of amyloid in test-tube conditions. Amyloid is the major ingredient of the Alzheimer’s plaques. The purpose of the study is to determine whether this product is safe and effective in treating AD and what dose is best. This natural product (called NIC5-15) is found in many foods, including soy beans, and has been already approved by the Food and Drug Administration (FDA) for use as a dietary supplement. For more information, please contact Sirisha Nandipati at 212-241-1514. GCO # 05-0090 (0001 01); Principal Investigator: Hillel Grossman, M.D., MSSM IRB approved through 12/19/2008.

 

Age at Onset and Cardiovascular Risk Factors in Very Late-Onset Alzheimer’s Disease (AD)

The overall aims of this project are to examine the role of cardiovascular risk factors for cognitive decline and AD in elderly men. A growing body of evidence indicates that risk factors for cardiovascular disease also increase the risk of developing both vascular dementia (VaD) and AD. Most, but not all, of the evidence comes from research that has studied predominantly women, especially among the very old. In this project, we will conduct an extensive CvRF assessment in an elderly male veteran sample, recruited through the Bronx Veterans Affairs Medical Center. Male veterans, 75 years old and older with no memory problems and no history of stroke (TIAs and miniokes are acceptable) may qualify to participate in this research study which consists of comprehensive interview including memory and thinking tasks, health and medical histories and a blood draw (approximately 3 tablespoons). We will also look to follow-up every year. For more information, contact our research coordinator at 718-367-5727. GCO#79-141, Project 4, Principal Investigator:
Jeremy Silverman, Ph.D., IRB approved through 3/31/09.

 

Brain Tissue Donation Program

The goal of this program is to improve existing treatments and to develop new treatments for AD, which is not possible without the generosity and altruism of individuals who partner with Mount Sinai by participating in our brain donation program. Therefore, men and women, with and without memory impairment are eligible to provide their “intent” to consent for this program. There are several benefits to participation and we have specially trained staff available to discuss these benefits, the donation process, and any related concerns that you and your family might have. For more information, please contact Karen Dahlman, Ph.D. at 212-241-1844. GCO #84-119 and #79-141, MSSM IRB approved through 3/31/09.

Note: Spanish-speaking participants are welcome in all studies. All study participants receive reimbursement for any related expenses. Participants without AD receive monetary compensation for their time.

If you are interested in any of the above research studies, please contact the Alzheimer’s Disease Research Center
at 212-241-8329. Mount Sinai also has Satellite clinics specializing in AD and other Memory Disorders located at:

Elmhurst Hospital in Queens: 718-334-3983
Bronx VA Medical Center: 718-584-9000 ext. 5199

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