Clinical Research

Clinical Trials

D-5 Trial for those with Alzheimer's Disease

A new phase II study is being conducted in the US and Canada to evaluate the safety and effectiveness of an experimental drug known as ELND005, or scyllo-inositol, for the potential treatment of Alzheimer's disease (AD). ELND005 is one of the many cutting edge disease-modifying agents that are being tested to determine if it can reduce the progression of AD by breaking down the build-up of amyloid plaques in the brain. Volunteers will receive either active study drug or placebo, an inactive sugar pill,for 18 months, the duration of the study. All participants will be carefully monitored at the research clinic throughout the study. Volunteers are eligible to participate if they meet the following criteria:

are between 50 - 85 years of age
have a diagnosis of probable AD
have a Mini-Mental Status Exam (MMSE) score of 16-26, inclusive
have a magnetic resonance imaging (MRI) scan consistent with AD diagnosis
have a caregiver who is able to attend all study visits

If you are a physician, and judge that this research study may be suitable for your patient, please be sure to discuss this information with your patient, and give the following contact information. If you meet the above criteria, or know someone who does, please contact Andrew Vigario, Clinical Research Coordinator at the Mount Sinai Alzheimer's Disease Research Center by phone at (212) 241-5692, or via e-mail at andrew.vigario@mssm.edu. MSSM GCO #08-0449 IRB approved through 6/16/09.

RAGE Trial for those with Alzheimer's Disease

Researchers are participating in a nationwide study that will test an experimental treatment, RAGE Inhibitor, to target the source of Alzheimer's disease. One of the proteins that surround the amyloid plaques in Alzheimer's disease 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 the Mount Sinai Alzheimer's Disease Research Center. Tel:(212) 659-8885, E-mail: 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); Jane Martin PhD, Principal Investigator, MSSM IRB approved through 08/31/08.

Trial of a Nutritional Supplement in Alzheimer's Disease

We are seeking patients with Alzheimer's disease 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 memory and thinking of Alzheimer's disease patients. A previous study examining the effects of resveratrol on the cognition of Alzheimer's disease patients has had encouraging results. However, the Food and Drug Administration (FDA) has not yet approved resveratrol for the treatment of Alzheimer's disease. The study will be conducted over 12 months and is funded by the Alzheimer's Association. For more information, please contact our research coordinator at (212) 241-8329. GCO #05-1394 (0001), Principal Investigator: Mary Sano, Ph.D., MSSM IRB approved through 4/30/2009.

A Dietary Supplement for the Treatment of Alzheimer's Disease

We are seeking patients with Alzheimer's disease 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 Alzheimer's disease 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 our research coordinator at (212) 241-8329. GCO # 05-0090 (0001 01); Hillel Grossman, M.D., Principal Investigator, MSSM IRB approved through 12/19/2008.

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 our research coordinator at (212) 241-8329. Mount Sinai also has Satellite clinics specializing in AD, and other Memory Disorders locations.