Clinical Trials

Scientists can learn a tremendous amount about dementia and the brain from the study of healthy individuals as well as those who have been diagnosed with memory disorders. At the Alzheimer’s Disease Research Center (ADRC), our research goals are not only to improve diagnosis, delay progression, and enhance the well-being of those with Alzheimer's disease, but also to learn more about the normal process of aging.

Would you like to get information about prevention of memory loss and dementia from our ADRC activities including educational events, newsletters, and studies?  If so, please fill out our ADRC Interest Group form and let us know what you’d like to hear more about! 

All of the research conducted at the ADRC takes place at our Upper East Side campus. Clinical studies currently under way at the ADRC include:

The purpose of the AHEAD Study is to determine whether intervention with the investigational treatment, BAN2401 (lecanemab), can lower levels of amyloid in the brain to slow early brain changes associated with Alzheimer’s disease (AD) and therefore help prevent memory loss before symptoms are apparent in healthy individuals at-risk for developing AD. Clinicians and researchers believe this build-up of amyloid plaques in the brain may play a key role in the development of AD symptoms, such as memory loss and problems with thinking. Studies have shown that changes caused by AD occur in the brain many years before a person shows symptoms of the disease.

To be eligible for the 4-year AHEAD Study, you must be between the ages of 55-80, and have not been diagnosed with a cognitive disorder and be able to get MRI and PET scans. Study PET scans will determine if you have intermediate or elevated levels of amyloid in the brain. A study partner, either close relative or friend, must be willing to attend one study visit in person and answer questions on the phone. If you qualify for the AHEAD Study, you will receive the study treatment (investigational treatment [BAN2401- lecanemab] or placebo) intravenously (IV) every other week or monthly, depending on your level of brain amyloid.

If you are interested in learning more about the study, please contact our study coordinator Allie Ardolino at (212) 241-8329. Principal Investigator: Mary Sano, PhD; GCO 20-1729, ISMMS IRB approved through 12/31/2023.

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a nation-wide, longitudinal study, aimed at increasing the pace of investigation and discovery of treatments that slow or stop the progression of Alzheimer’s disease. The purpose of this study is to determine the relationships among clinical, imaging, genetic, and biomarker characteristics of the entire spectrum of Alzheimer’s disease from normal aging to dementia. For more than a decade, ADNI researchers have been working to better understand the disease. Now, in this next step, this initiative is studying how quickly brain cognition and function changes and how best to measure these changes.

ADNI3 is an observational study and no medications are involved. We are looking for participants with normal cognition, Mild Cognitive Impairment (MCI), or mild Alzheimer’s dementia. Participants may be fluent in English or Spanish. Participants will come in for yearly visits, which may be split up into multiple appointments. Over the course of the 5-year study, participants will undergo clinical, cognitive, and genetic tests, as well as MRI scans, PET scans, and at least one lumbar puncture. Participants are also asked to come in with a “study partner,” who may be a family member or close friend to aid in the study activities.  If you are between 55-90 years old, in stable health, and are willing to undergo the procedures listed above, please contact the study coordinator at (212) 241-8329. Principal Investigator: Hillel Grossman, MD; GCO #91-208 (29) HS#17-01326, ISMMS IRB approved through 07/31/2024.

Based on experiences unique to our lives and our cultures, music and other pleasant activities are often associated with strong memories and meaningful experiences from within our lives. In patients with memory problems, music therapy, music and other activities may play a role in improving quality of life.

In collaboration between The Louis Armstrong Center for Music and Medicine and the Alzheimer’s Disease Research Center, this 12-month study will assess the role of pleasant activities, home-based singing and music therapy in patients with Alzheimer’s disease or Mild Cognitive Impairment, ages 55 and older. This study does not involve investigational medication. For more information, please contact Elisha Israel at 212-241-8329. Co-Principal Investigators: Mary Sano, PhD, Joanne Loewy DA, LCAT, MT-BC. GCO: 19-0243-00001-01-PD.

Researchers at the Diabetes, Obesity and Metabolism Institute and the ADRC are recruiting participants over the age of 55 with a diagnosis of probable early Alzheimer’s Disease or Mild Cognitive Impairment and sleep disturbance to test if light treatment comparable to sunlight in your home improves cognition, sleep and metabolism. Participants will be randomly assigned to either bright or dim light in their home on a daily basis for 6 months. The duration of the study is about 12 months. You are not eligible if you require insulin, have urinary incontinence, are blind or suffer from severe eye disease. There will be 6 visits total for the completion of the study visits (between ADRC at Mount Sinai and Mount Sinai St. Luke’s). Visits will include blood and urine testing, assessment of sleep and light exposure via a wearable watch, and a 3-hour test of how your body uses sugar. There is no cost to participate in the study. You will be reimbursed for the time you spend participating. For more information, please contact study coordinator Fernando Gonterman at 212-659-9574. PI: Mariana Figueiro, PhD, D HS# 18-00883; GCO 17-2685.

This national study of healthy elders and those with memory problems examines how memory disorders affect cognitive abilities and daily functioning. For those willing to be followed on a yearly basis, we provide free memory and medical evaluations to both healthy elders over age 74 and those of any age who have been diagnosed with Alzheimer's disease or related diseases including Mild Cognitive Impairment. Participation does not include treatment.

For more information or to schedule an appointment, call 212-241-8329.

In addition to the above studies, the ADRC has several active studies that are no longer recruiting new participants. These are:

The Grape Seed Extract Study is assessing the effect of grape seed extract in people with Alzheimer’s to determine the safest and most effective dose. Grape seed extract is a natural product that has been shown in laboratory studies to block the formation of brain toxic proteins involved in Alzheimer’s disease. Participants will either receive the active compound or a placebo.

We are looking for older adults who are experiencing memory loss that may be due to Alzheimer’s disease, who are fluent in either English or Spanish, and who have someone who can act as a study partner. There is no charge to participants. For more information, contact our research coordinator at 212-241-8329. Principal Investigator: Hillel T. Grossman, MD. ISMMS PPHS approved through 11/30/20. (GCO #09-0307)

EXERT is a phase 3, multi-center 18 month trial examining the effects of low intensity stretching, balance, and range of motion exercises verses high intensity aerobic exercise on cognitive function and on biological markers of Alzheimer’s Disease in older adults with mild memory loss. Participants will exercise at a participating local YMCA under the supervision of a personal trainer; they will complete their assigned exercise program four times per week for 18 months. In the first twelve months of the study, two of the four weekly sessions will be supervised by the trainer. In the final six months, participants will continue to complete their assigned exercise program at the YMCA without supervision. We are looking for people who are experiencing mild memory loss or lapses, are between the ages of 65 and 89, have a study partner available, and would be able to travel to either the Harlem YMCA on 135th St. or the Vanderbilt YMCA on 47th St. Interested parties should call our research coordinator at 212-241-8329. Principal Investigator: Clara Li, Ph.D. GCO #16-2044 approved by 2/1/2022.

The PEGASUS study is a research study for people who have been diagnosed with Alzheimer’s disease or Mild Cognitive Impairment (MCI). The study is being conducted to confirm the safety and tolerability of the drug AMX0035, which is a combination of two drugs, Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA). In studies of mice, PB and TUDCA, when used together, were found to protect neurons in the brain from dying and reduce beta-amyloid deposits. Scientists believe an increased amount of amyloid in the brain plays an important role in the development and progression of Alzheimer’s disease. Both PB and TUDCA were found to be safe and tolerable in people with neurodegenerative diseases, including ALS and Huntington’s Disease, when used individually.

This is a placebo-controlled trial, and we are recruiting participants between the ages of 55-89 who have a diagnosis of probable Alzheimer’s disease or MCI. Participants will take medication on a daily basis and the length of the study, which involves 6 visits to Mount Sinai and 2 phone calls, is 8 months. There is no cost to participate. For more information, please contact the ADRC at 212-241-8329. PI: Judith Neugroschl, MD. IRB GCO 18-01284, 18-2125. GCO Expiration date: 10/14/2020.

Riluzole is FDA-approved for the treatment of ALS (Lou Gerhig’s Disease) and previous research suggests Riluzole may also be effective for the treatment of Alzheimer’s disease. Riluzole, an oral medication, helps to regulate a chemical in the brain called Glutamate, which normally sends signals between neurons in the brain for memory and learning.

This is the first study investigating Riluzole as a potential treatment for Alzheimer’s disease. We are recruiting patients between the ages of 50-95 who have a diagnosis of mild Alzheimer’s disease and who are interested in participating in a clinical trial. This is a placebo-controlled trial and participation involves taking the medication on a daily basis for 6 months and coming to Mount Sinai for monthly visits. For more information please contact the ADRC at 212-241-8329. PI: Ana Pereira, MD. IRB GCO 18-0623, 18-0664 approved through 1/15/20.

The TANSNIP study is an observational study that will include taking pictures of the brain to see if there are any brain changes present in those who have the risk factors for heart disease, or who have normal to mild cognitive impairment. The purpose of this study is to determine the presence of risk factors for heart disease such as high level of fat in the blood, high blood pressure, diabetes and obesity, and clogging of the arteries in people who have difficulty with memory, attention, and/or concentration. In addition we will determine if these risk factors for heart disease also cause problems with activities of daily living, motivation, depression symptoms and the likelihood to keep a healthy lifestyle. The study team is seeking healthy participants between the ages of 60 and 85, who can attend study appointments with a study partner and are not taking any Alzheimer’s disease medications. Participants will not have to pay for investigational diagnostic procedures, and will be reimbursed for certain traveling expenses needed to attend clinical visits throughout the study. This research will take place at Mount Sinai’s Upper East Side campus. For more information about the TANSNIP study, please contact a study coordinator at 212-659-8883. PI: Valentin Fuster MD, PhD, MACC; GCO#: 14-0701(0003); HSM#: 15-0538; ISMMS IRB approved through 7/27/2019.

Scientists believe Alzheimer's disease is caused by the build-up of a protein in the brain called beta-amyloid. The EARLY study is investigating whether a new medication (JNJ-54861911) can delay or prevent memory loss in older adults with elevated levels of brain beta-amyloid before they have symptoms of Alzheimer's disease. This is a placebo-controlled trial, in which participants will be randomly assigned to receive a low or high dose of the medication or a placebo. The EARLY study is recruiting healthy adults between the ages of 60-85 who are worried about developing Alzheimer’s Disease. Participation requires taking the medication by mouth every day for 5 years, regularly attending follow up safety visits at Mount Sinai, and having a close friend of family member who can act as a study partner. For more information, please contact Emily Lampshire at (212)-659-8301 or by email at emily.lampshire@mssm.edu. Principal Investigator: Mary Sano, PhD. GCO#: 17-0707; HSM#: 17-01385. ISMMS IRB approved through 4/3/2019.

This study evaluates the efficacy and safety of a drug (aducanumab or BIIB037) in individuals who are experiencing Alzheimer’s disease related symptoms such as cognitive impairments and memory loss due to elevated levels of amyloid protein in their brains. Scientists believe an increased amount of amyloid in the brain plays an important role in the development and progression of Alzheimer’s disease.

We are looking for participants between the ages of 50-85 with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease. It is required that participants have a study partner who can provide information about the participant’s health and attend appointments. There is no cost to participate in this study and participants can receive reimbursements for specific costs. For more information, contact Allison Ardolino at 212-241-0438 or allison.ardolino@mssm.edu. Principal Investigator; Amy Aloysi, MD; GCO# 16-1623:HSM#-16-00912. GCO Approved 8/9/17-8/8/18

The purposes of this study are to examine two genes to see if they provide insight into someone’s likelihood of developing Alzheimer’s disease and (2) to test a drug called pioglitazone (AD-4833), which may slow the progress of Alzheimer’s disease in those who show no signs of the condition.

Principal Investigator: Judith Neugroschl, MD; GCO#: 13-1688; HSM#: 13-00720; ISMMS IRB approved through 11/18/2015.

This study investigates the safety, tolerability, and effectiveness of an insulin nasal spray administered to people with Alzheimer’s disease or mild cognitive impairment. Participants either receive the insulin nasal spray or a placebo nasal spray for 12 months; for the following six months, all participants receive the insulin nasal spray.

We are looking for 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, and have a study partner who can also attend all study visits. There is no charge for participation and we serve lunch at some visits. For more information, contact Michael Kinsella at 212-241-8329. Principal Investigator: Hillel T. Grossman, MD. GCO#: 91-0208(0017); HSM#: 13-00768; ISMMS IRB approved from 10/29/2016 – 10/28/2017.

Our study looks at the ability of a drug (LY2062430 or solanezumab) to delay Alzheimer’s disease-related memory loss in older people who have elevated levels of amyloid or beta amyloid proteins in their brain but are not yet displaying symptoms of the disease. Scientists believe these proteins play a key role in development of AD-related memory loss.

We are looking for healthy participants between ages 65-85 who have a study partner who can provide information about the participant’s health, attend appointments, and assist with correctly taking study medication. There is no cost to participate and participants will be paid for certain clinical visits. For more information, contact Kelly Pun at 212-241-8329. Principal Investigator: Mary Sano, PhD; GCO#: 91-0208(0018) and 91-0208(0019); HSM#: 14-00067; ISMMS IRB approved through 03/18/17 - 03/17/2018.