MSSM Studies

Alzheimer’s Disease Neuroimaging Initiative-2 (ADNI-2)

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, 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. Participants with cognitive or memory complaints are welcome. Participants’ 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 Cleopatra McGovern at 212-241-1514. MSSM #IF1245934; Principal Investigator: Hillel Grossman, MD; MSSM approved through 10/31/13.

Nerve Growth Factor Study

Mount Sinai researchers will be participating in a phase 2 clinical trial that is being conducted nationwide. This study will evaluate whether a type of gene therapy technique is safe, well-tolerated, and of benefit to people with Alzheimer's Disease (AD). In this clinical trial, a study drug named CERE-110 will be injected into an area of the brain affected by AD so that the body can make nerve growth factor (NGF). NGF is a naturally occurring protein that may increase the survival of neurons that die in AD. In this study, half of the participants will receive CERE-110 via neurosurgery and the other half will receive a placebo procedure. Participation will also include a medical examination and cognitive testing. All participants will be carefully monitored by a team of physicians for two years. In addition, all participants will be asked if they want to participate in a separate, open-ended protocol for further clinical observation. This study is open to eligible individuals with mild AD between the ages 55 and 80, who are in good general health, and are able to undergo surgery. If you would like information about this study, please contact Priyanka Ghosh at 212-659-8885 or priyanka.ghosh@mssm.edu. MSSM #09-0367; Principal Investigator: Judith Neugroschl, MD; MSSM approved through 4/13/13.

Alzheimer’s Disease Research Center Longitudinal Study

This is a national study of healthy elders and those with memory problems that examines how memory disorders affect cognitive abilities and daily functioning over time. For those willing to be followed on a yearly basis, free memory and medical evaluations are available to two groups: healthy elders over 74years old who may or may not be concerned about memory changes and those of any age who have a diagnosis of Alzheimer's disease and related diseases including Mild Cognitive Impairment. Participation in this research study does not include treatment; however doctors and psychologists will review test results, and provide a letter with a diagnostic impressions and recommendations. Participants will also be given information about other research opportunities as they become available, such as clinical trials, brain imaging studies, and surveys. For more information or to schedule an appointment, please call 212-241-8329. MSSM #84-119; MSSM approved through 4/1/13.

Neuroimaging in Head Injury and Cognitive Decline

This is a study investigating brain and memory and thinking problems associated with having a history of concussion or mild traumatic brain injury (TBI) in a sample of individuals between the ages of 50 and 89. The Department of Psychiatry is investigating whether having a history of concussion or mild TBI with and without mild cognitive impairment (MCI) is distinct by using MRI and tests of memory and thinking. The Department of Psychiatry is looking for participants with either a history of concussion/mild TBI and MCI or a history of TBI without MCI. Participants must be English speakers. Participants will receive compensation for their time. For more information, contact Corey Fernandez at 212-241-5290, or via e-mail at corey.fernandez@mssm.edu. MSSM #10-0954; Principal Investigator: Effie M. Mitsis, PhD, MSSM approved through 10/11/13.

Resveratrol Research Study

The Resveratrol research study looks to evaluate the safety, tolerability and effectiveness of Resveratrol when given to people with Alzheimer’s disease (AD). Resveratrol is a substance found in red wine and in the skins of certain red grapes. We will be studying the effect of Resveratrol on memory and thinking as well as cerebrospinal fluid (CSF) and blood biomarkers. In this study, individuals with Alzheimer’s disease will be given either Resveratrol or placebo (sugar pill) for 12 months. The study needs volunteers who are 50 years of age or older, have mild to moderate Alzheimer’s disease, are fluent in English or Spanish, can undergo testing procedures and have a study partner. Participants will receive compensation for procedures and will be provided lunch during study visits. For more information about the Resveratrol study, please contact Helene Geramian at 212.659.8885 or e-mail at helene.geramian@mssm.edu. This research will take place at Mount Sinai. Principal Investigator: Judith Neugroschl, MD; GCO: 91-208 (0015)(01) PS, HSM: 12-00068. MSSM IRB approved through 3/5/2013.

Trial of NIC5-15, a natural product in subjects with Alzheimer’s disease

We are seeking Veterans and non – Veterans with Alzheimer’s disease to participate in a research study of a natural product, NIC5-15 at the Bronx James 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 Emily Exter at 718-584-9000 ext 5179, or e-mail at emily.exter@mssm.edu. Principal Investigator: Hillel Grossman, MD. VA GRO#10-029 approved 5/23/12 - 5/2/2013.