NYU Langone’s Alzheimer’s Disease Research Center conducts clinical trials to identify new and promising approaches to treatment for neurological diseases that affect cognition.

To find out whether you are eligible to participate in a clinical trial, please call 212-263-0771 or email ADClinicalTrials@NYULangone.org.

Studies for People with Mild Cognitive Impairment, Alzheimer’s Disease, or Both

Alzheimer’s Disease Neuroimaging Initiative 3 (ADNI3) Protocol

This is a nonrandomized, natural history nontreatment study. Participants need to be between 55 and 90 years, and be healthy with no neurologic disease such as Alzheimer’s disease. Subjects receive longitudinal clinical and cognitive assessments, computerized cognitive batteries, biomarker and genetic tests, PET and MRI scans, and cerebral spinal fluid collection for up to five years. View full clinical trial information.

This study is actively enrolling new participants. For more information, email ADClinicalTrials@NYULangone.org.

A Study to Assess if BIIB080 Can Change Clinical Dementia Rating-Sum of Boxes Scores, and BIIB080 Safety and Tolerability When Injected nto the Cerebrospinal Fluid of Participants with Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 and 80 Years of Age (CELIA)

The purpose of this study is to test the safety, effectiveness, and tolerability of an investigational drug called BIIB080. This trial would include 735 participants that would be given either the study drug or the placebo. A placebo looks like the study drug but does not have active medication. Participants must be 50 to 80 years of age and have a clinical diagnosis of memory problems due to Alzheimer’s disease or mild Alzheimer’s disease dementia.

View full clinical trial information.

This study is actively enrolling new participants. For more information, call 212-263-5845 or email ADClinicalTrials@NYULangone.org.

A Study to Verify the Clinical Benefit of Aducanumab in Participants with Early Alzheimer's Disease (ENVISION)

This research study aims to determine whether aducanumab (ADUHELM) can slow down the progression of Alzheimer’s disease in those with early Alzheimer’s disease. Aducanumab is not an experimental drug and has accelerated approval by the U.S. Food and Drug Administration (FDA). Participants would be assigned to either aducanumab or a placebo. A placebo looks like the study drug but has no drug. Participants must be 60 to 85 years old and must be in good health apart from a clinical diagnosis of early Alzheimer’s disease.

View full clinical trial information.

This study is actively enrolling new participants. For more information, call 212-263-5845 or email ADClinicalTrials@NYULangone.org.

Innate Immunity Stimulation via TLR9 in Early AD

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of study drug called CpG 1018 ISS to slow or prevent Alzheimer’s disease (AD) progression. Alzheimer’s disease is caused by a buildup of amyloid and tau proteins in the brain. CpG 1018 ISS may trigger an immune response to reduce amyloid protein from building up in the brain. This study has three dose levels and is for patients who have been diagnosed with either mild cognitive impairment (MCI) or mild Alzheimer’s disease dementia. CpG 1018 ISS is considered investigational because it is not U.S. Food and Drug Administration (FDA) approved for preventing AD progression.

View full clinical trial information.

This study is actively enrolling new participants. For more information, call 212-263-5845 or email ADClinicalTrials@NYULangone.org.

Transcranial Photobiomodulation for Alzheimer’s Disease (TRAP-AD)

TRAP-AD is a research study investigating if an experimental treatment device will lead to improvement in cognition in adults with amnestic Mild Cognitive Impairment (aMCI). The treatment, transcranial photobiomodulation (t-PBM), uses near-infrared light therapy to stimulate certain parts of the brain that are thought to be affected in memory impairment. Infrared energy is a form of light not visible to the human eye. Researchers hope to determine the effectiveness of t-PBM for improving cognition in adults with aMCI.

View full clinical trial information.

This study is actively enrolling new participants. For information, contact Ana Peterson at 646-926-2431 or email Anna.Peterson@NYULangone.org.

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease-Modifying Treatments in Individuals with a Type of Early-Onset Alzheimer’s Disease Caused by a Genetic Mutation (DIAN-TU)

In 2012, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University in St. Louis launched the first secondary prevention trial for Dominantly Inherited Alzheimer’s Disease (DIAD) families. The initial study drug arms tested in the trial were focused on amyloid-based therapies. The DIAN-TU is now planning to launch the Tau Next Generation (Tau NexGen) trial which will test three different experimental drugs focused on therapies that target tau tangles.

The first tau study drug to be tested is known as E2814 and is designed to target tau tangles; in addition, an active anti-amyloid study drug called lecanemab (designed to target amyloid plaques) will also be administered. Both study drugs have been developed by Eisai Co., Ltd. This will be the first Alzheimer’s prevention trial to target both tau tangles and amyloid plaques with two drugs at the same time. The research team continues to evaluate additional study drugs to select, and plans to choose from two classes of investigational tau drugs that act in different ways.

The trial’s goal is to determine the safety, tolerability, and effectiveness of each study drug. The DIAN-TU secondary prevention trial will determine if these investigational medications can prevent, delay, or possibly even reverse Alzheimer’s disease changes in the brain.

View full clinical trial information.

This study is actively enrolling new participants. For more information, call 212-263-5845 or email ADClinicalTrials@NYULangone.org.

A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients with Early AD (VIVA-MIND)

VIVA-MIND is a clinical research trial testing an investigational drug for people, age 50 to 89, who are experiencing mild cognitive impairment (MCI) or have been diagnosed with mild Alzheimer’s disease (AD). This stage of the disease, MCI through mild AD, is also known as “early AD”. The trial is designed to determine if the study drug, varoglutamstat, can stabilize or slow-down memory and thinking problems that increase as early AD progresses.

View full clinical trial information.

This study is actively enrolling new participants. For more information, email ADClinicalTrials@NYULangone.org.

New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study

New IDEAS is a nationwide research study for people who have memory loss. The study is looking at a type of FDA-approved brain imaging called an amyloid PET scan. It is a safe, noninvasive test that takes pictures of the brain. New IDEAS is trying to find out if PET scan results help guide doctors in diagnosing and treating memory conditions. We want to see if this leads to better health.

View full clinical trial information.

This study is actively enrolling new participants. For more information, email ADClinicalTrials@NYULangone.org.

Ongoing Clinical Trials (Not Actively Recruiting)

Memory Improvement Through Nicotine Dosing (MIND) Study

The MIND study seeks to determine whether daily transdermal nicotine has a positive effect on early memory loss in people diagnosed with mild cognitive impairment. We are enrolling healthy, nonsmoking adults over the age of 55. There is no cost to participate. View full clinical trial information.

This study is active, but no longer enrolling new participants. For more information, email ADClinicalTrials@NYULangone.org.

A Study of JNJ-63733657 in Participants with Early Alzheimer’s Disease (Autonomy)

The purpose of the study is to see how safe the investigational medicine JNJ-63733657 is, and whether it is effective for people with early Alzheimer’s disease. You may be able to participate if you are 55 to 80 years of age, are experiencing a gradual decline in your cognitive abilities (such as memory, problem-solving skills, and ability to pay attention and think clearly) over at least the past 6 months or have been diagnosed with early Alzheimer’s disease and have a reliable close friend, relative, or spouse who can be your study partner. This should be someone who spends at least 10 hours every week with you, knows your daily functioning well, and is able to accompany you to visits to the study center. Additional eligibility criteria will be assessed by the study doctor or study team. Qualified participants will receive study-related medical care and either the investigational medicine or placebo at no cost. The study will not pay for other medical care or current medications needed to support your daily healthcare routine.

View full clinical trial information.

This study is active, but no longer enrolling new participants. For more information, email ADClinicalTrials@NYULangone.org.

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer’s Disease Subjects (APOLLOE4)

The purpose of this study is to determine if the study drug called ALZ-801 is safe, if it is well tolerated (how your body reacts to the study drug) and if it is effective in treating Alzheimer’s disease. ALZ-801 has an active agent called tramiprosate, which interferes with the formation of abnormal forms of a protein called beta amyloid or Aβ-42. These abnormal amyloid proteins are thought to play an important role in causing cell damage in the brain and the development of AD. ALZ-801 inhibits the formation of these abnormal toxic proteins and may be able to slow down or stop the worsening of Alzheimer’s disease. To determine if ALZ-801 is effective, a comparison must be made between ALZ-801 and placebo. A placebo looks like the study drug but does not contain any active drug. Researchers use a placebo to see if a study drug works better or is safer than not taking anything at all.

View full clinical trial information.

This study is active, but no longer enrolling new participants. For more information, email ADClinicalTrials@NYULangone.org.

Antiviral Therapy in Alzheimer’s Disease (VALAD)

This study is investigating the efficacy of treating people who have Alzheimer’s disease with the generic antiviral drug valacyclovir. Valacyclovir—taken at 2 to 4 g daily and repurposed as an anti–Alzheimer’s disease drug—is being compared with matching placebo in the treatment of 130 people who have mild Alzheimer’s disease (65 valacyclovir, 65 placebo) and who test positive for herpes simplex virus-1 or herpes simplex virus-2. The study is a randomized, double-blind, 18-month phase 2 proof of concept trial. This study is funded by the National Institutes of Health.

View full clinical trial information.

This study is active, but no longer enrolling new participants. For information, contact Anaztasia Ulysse at 212-263-0771, or email ADClinicalTrials@NYULangone.org.

Biogen, EMBARK Protocol 221AD304

The purpose of the EMBARK study is to assess the long-term safety and efficacy of aducanumab in participants with Alzheimer’s disease who were actively participating in aducanumab clinical studies EVOLVE, PRIME, EMERGE, and ENGAGE as of March 21, 2019. Aducanumab is a human monoclonal antibody that is made in a laboratory. Antibodies are naturally made by the body to fight infection and disease. One of the key features of Alzheimer’s disease is that a higher amount of a substance called amyloid beta (a protein) is found in the brains of people with Alzheimer’s disease than in the brains of people who do not have the condition. These deposits of amyloid beta are known as plaques. The study drug is designed to attach to amyloid beta and therefore may remove existing plaques.

View full clinical trial information.

This study is not actively enrolling new participants. For more information, contact Anaztasia Ulysse at 212-263-0771 or email ADClinicalTrials@NYULangone.org.

TRAILBLAZER-ALZ 2: A Study of Donanemab (LY3002813) in Participants with Early Alzheimer’s Disease

The TRAILBLAZER-ALZ 2 clinical research study is evaluating the safety and effectiveness of an investigational drug for people with early symptomatic Alzheimer’s disease. The study involves people who have memory loss that has gotten worse over the last six months or more. If you are experiencing memory loss or struggling to perform complex task, you may prequalify. Participants are randomly assigned into one of two groups. They receive either the investigational drug or placebo. If you prequalify, participation can last up to 2 years and 7 months, with up to 26 appointments with the study center.

View full clinical trial information.

This study is active, but no longer enrolling new participants. For more information, contact Anaztasia Ulysse at 212-263-0771, or email ADClinicalTrials@NYULangone.org.

Clarity AD: A Study to Confirm Safety and Efficacy of Lecanemab in Participants with Early Alzheimer’s Disease

The Clarity AD Study is looking for participants to evaluate an investigational drug for those who have experienced memory loss due to early Alzheimer’s disease. In order to qualify, the patient must meet the following criteria:

• be between 50 and 90 years old
• have a recent history of memory decline with gradual progression over the last year
• have a study partner to help meet all study requirements
• be able to get an MRI

There are additional criteria that are reviewed by the study team at the study center at the first visit.

View full clinical trial information.

This study is active, but no longer enrolling new participants. For more information, email ADClinicalTrials@NYULangone.org.