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.

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:

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 Florence Lau at 212-241-8329 or florence.lau@mssm.edu. GCO #16-2044 approved by 2/20/2019.

Nicotine has been proven to stimulate at area of the brain important for memory and thinking. The Memory Improvement through Nicotine Dosing (MIND) study is looking at whether or not a daily dose of nicotine, through a transdermal patch, will have a positive effect on early memory loss. The study will consist of 12 visits over a 2-year period. Participants will receive either daily nicotine or placebo patches.

We are looking for non-smoking adults ages 55-90 who notice changes in their memory or whose family members notice changes. Participants must also have a study partner who has regular contact with the participant and can attend all study visits. There is no cost to participate in this study.

For more information, please contact Allison Ardolino at (212)-241-0438 or by email at allison.ardolino@mssm.edu. Principal Investigator: Clara Li, PhD.; GCO#91-0208(30), HSM# 17-00245; ISMMS IRB approved through 4/20/2019.

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 Florence Lau at 212-241-8329. Principal Investigator: Hillel T. Grossman, MD. ISMMS PPHS approved through 11/30/2018. (GCO #09-0307)

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 07/27/2018.

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:

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.