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 4/30/2010.

Investigational Clinical Amyloid Research in Alzheimer’s

We’re looking for volunteers to participate in a clinical study to evaluate the safety and effectiveness of an investigational drug to help control the progression of Alzheimer’s disease. Study participants will be randomized to the investigational product or placebo (a treatment with no active ingredient). There is a 60% chance of receiving the investigational drug and a 40% chance of receiving a placebo. Study participants will be asked to attend 15 study visits during an 83-week period, receive six infusions of the investigational drug every 13 weeks for 65 weeks, and have blood tests and study-related physical and clinical exams. Study participants may be eligible if they are between 50-85 years of age, have a diagnosis of probably AD, and have a caregiver who is willing to be involved in the study. For more information, please call George Marzloff at (212) 241-1514, or email at George.Marzloff@mssm.edu. MSSM #08-0241, 08-0242; Principal Investigator: Hillel Grossman, M.D. MSSM approved through 2/6/10.

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 #08-00443 IRB approved through 6/19/10.

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). 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 mild-to-moderate AD; 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; Principal Investigator: Hillel Grossman, M.D. MSSM approved through 3/16/10.

Antipsychotic Discontinuation in Alzheimer’s Disease

We are looking for volunteers to participate in a research study that uses risperidone, which is an FDA-approved antipsychotic drug, in the current study as an experimental treatment for people with Alzheimer's disease (AD), who suffer from hallucinations, delusions, agitation and/or aggression. Risperidone is not a treatment for memory difficulties, but rather is being studied in this trial to see if it will improve behavioral difficulties associated with AD. This study continues over a period of 48 weeks. All participants will be carefully monitored at the research clinic throughout the study. Participants are eligible to participate if they are between 40-95 years of age, have a diagnosis of probable AD, have a Mini-Mental State Examination (MMSE) score between 5-26 (at the time of the screening visit), and 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 #06-0930; Principle Investigator: Corbett Schimming, M.D. MSSM approved through 8/31/10.