Medication and Neuroimaging Studies
The Alzheimer’s Disease Research Center at Icahn School of Medicine at Mount Sinai is seeking volunteers for the A4 study. Studies have shown that changes occur in the brain many years before a person shows the symptoms of Alzheimer’s disease (AD) dementia. We know that a protein called “amyloid” or “beta-amyloid” forms plaques in the brains of people with AD. Scientists believe that the buildup of amyloid in the brain may play a key role in the eventual development of AD-related memory loss. The A4 study is testing a drug known as LY2062430 (also called “solanezumab”) in older individuals who have evidence of elevated amyloid build-up in their brains, but who do not yet show symptoms of AD in order to slow possible AD-related damage in the brain and to delay progression of AD-related memory loss. The purpose of this study is to test whether solanezumab can slow the progression of memory problems associated with brain amyloid. Amyloid build-up will be identified in potential participants through a special positron emission tomography (PET) scan technique. The study team is seeking healthy participants between the ages of 65 and 85, who have someone who can be a project partner (spouse, adult child, other family member, or caregiver) to provide information about their health, attend study appointments, and assist with correctly taking the study medication. Participants will not have to pay for investigational medication, and will be paid for certain clinical visits throughout the study. This research will take place at Mount Sinai’s Upper East Side campus. For more information about the A4 study, please contact a study coordinator at 212-241-8329. PI: Mary Sano, PhD; GCO#: 91-0208(0018) and 91-0208(0019); HSM#: 14-00067; ISMMS IRB approved through 03/17/2016.
Volunteers are being recruited for the NOBLE study. This study is evaluating an investigational drug for patients with mild to moderate Alzheimer’s disease that may work by protecting brain cells which would result in improved memory. Participants will receive the study drug or a placebo and participate in the study for about 14 months, which includes screening, about one year study treatment, and follow up to check safety. We will also be studying the effect of the drug on brain magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF). The study needs women and men aged 55-85 years old with mild to moderate Alzheimer’s disease who have been receiving donepezil (Aricept®) treatment for at least 6 months and who have a study partner with regular contact that can attend study visits. Participation will be at no cost to the participant. For more information about the NOBLE study, please contact one of our coordinators at 212-241-8329. This research will take place at Mount Sinai’s Upper East Side campus. PI: Amy Aloysi, MD. GCO#: 91-208 (20). HSM#: 14-00065. ISMMS IRB approved through 3/17/2016.
Merck EPOCH Trial
The Alzheimer's Disease Research Center at Mount Sinai is recruiting volunteers for the multi-center Merck EPOCH trial. This study is investigating the safety, tolerability, and efficacy of a medication, MK-8931, in patients with mild to moderate Alzheimer's disease. MK-8931 is an oral, β-amyloid precursor protein, site-cleaving enzyme (BACE) inhibitor and is hoped to slow the progression of Alzheimer's disease. Patients will be randomly assigned to take a low dose of study medication, a high dose of study medication, or a placebo for 78 weeks. The study needs patients with a diagnosis of Alzheimer's disease who are 55 to 85 years old, are fluent in English or Spanish, can attend all study visits, participate in neuropsychological testing, receive MRIs, and who have a close friend or family member who can act as a study partner. All study visits will take place at Mount Sinai's Upper East Side campus and there will be no cost to the patients. For more information about the EPOCH study, please contact study coordinator, Emily, at 212-241-0438 or email@example.com. Principal Investigator: Judith Neugroschl, MD; GCO# 13-0701; ISMMS IRB approved through 1/5/2016.
Volunteers are being recruited for the SNIFF study. This study is investigating the safety, tolerability, and effectiveness of an insulin nasal spray when given to people with Alzheimer’s disease (AD) or mild cognitive impairment. Insulin is a hormone in your body that helps your cells use sugar. We will be studying the effect of this insulin nasal spray on memory and thinking as well as cerebrospinal fluid (CSF) and blood biomarkers. In this study, subjects will be given either the insulin nasal spray or a placebo nasal spray for 12 months, and for 6 months all subjects will receive the insulin nasal spray. The study needs volunteers who are 55 years of age or older, are diagnosed with mild cognitive impairment or Alzheimer’s disease, are fluent in English or Spanish, can attend all study visits, participate in study testing and receive MRIs, and have a study partner who can also attend all study visits. Participation will be at no cost to the study participant and for some of the visits, lunch will be provided. For more information about the SNIFF study, please contact one of our coordinators at 212-241-8329. This research will take place at Mount Sinai’s Upper East Side campus. Principal Investigator: Hillel T. Grossman, MD. Enrollment to begin soon.
The Alzheimer’s Disease Research Center at the Icahn School of Medicine at Mount Sinai is seeking volunteers for the TOMMORROW study. The purposes of this study are (1) to examine two genes to see if it’s possible to predict someone’s likeliness to develop Alzheimer’s based on these inherited genes and (2) to test a drug called pioglitazone (AD-4833), which may slow the progress of Alzheimer’s disease in those who currently show no signs of the condition. In this study, the participants will be given a blood test to determine if they are at an elevated risk of developing Alzheimer’s disease and memory, thinking, orientation, and language skills tests to confirm that they are mentally healthy. Those who qualify will then be given a study drug or placebo to take over a five year period. The study team is seeking healthy participants between the ages of 65 and 83, who have someone who can be a project partner (spouse, adult child, other family member, or caregiver) to provide information about their health, attend study appointments, and assist with correctly taking the study medication. Participants will not have to pay for investigational medication, and transportation assistance may be available. This research will take place at Mount Sinai’s Upper East Side campus. For more information about the TOMMORROW study, please contact a study coordinator at 212-241-8329. Principal Investigator: Judith Neugroschi, MD; GCO#: 13-1688; HSM#: 13-00720; ISMMS IRB approved through 11/18/2015.
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 age 74 years 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.
To schedule an evaluation, please call 212-241-1844.
Dr. Mary Sano
One Gustave L. Levy Place
New York, NY 10029
Tel: 718-584-9000, ext. 5199
James J. Peters VA Medical Center
130 West Kingsbridge Road
Bronx, NY 10468