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

A Study of ONO-2020 in Participants With Mild to Moderate Alzheimer's Disease

This Phase 2 clinical trial is testing the safety and potential benefits of ONO-2020, an investigational drug being studied for mild to moderate Alzheimer’s disease (AD). ONO- 2020 is an epigenetic regulator, meaning it may influence how certain genes are turned on or off, with the goal of improving memory and thinking abilities. Participants will be randomly assigned to receive one of two doses of ONO-2020 or a placebo, taken by mouth once a day for 26 weeks. A small group of participants will also undergo additional testing to look at Alzheimer’s-related changes in the spinal fluid. Researchers will track all participants for four weeks after the treatment ends to assess any lasting effects. The goal of this study is to learn whether ONO-2020 can safely slow or improve cognitive decline in people living with Alzheimer’s disease.

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

A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy (cAPPricorn-1)

This research study is evaluating the safety and effectiveness of ALN-APP, an investigational drug designed to slow the progression of Cerebral Amyloid Angiopathy (CAA). CAA is a condition caused by a buildup of amyloid in the blood vessels of the brain and can lead to stroke or cognitive decline. The study includes adults diagnosed with either sporadic CAA (sCAA) or Dutch-type CAA (D-CAA). Participants will be randomly assigned to receive ALN-APP or placebo for 24 months in a double-blind phase. After this period, eligible participants may continue in an optional 18-month open-label extension where everyone receives ALN-APP. Researchers aim to assess how ALN-APP impacts disease progression, as well as its safety and effects in the body.

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This study is actively enrolling new participants. For more information, 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.

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

A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation (DIAN-TU-002)

DIAN-TU-002 is a prevention study testing the effectiveness of an investigational drug, remternetug, in individuals who carry a genetic mutation that causes Alzheimer’s disease (AD). These participants are currently asymptomatic but at high risk of developing AD. Remternetug is a monoclonal antibody designed to target and remove amyloid plaques from the brain. The study aims to evaluate the drug’s effects on brain biomarkers, as well as its safety and tolerability. In Stage 1, researchers will test whether remternetug can prevent or reduce amyloid buildup compared to placebo. In Stage 2, they will examine how early treatment affects other signs of Alzheimer’s disease compared to individuals who are not receiving the drug. Researchers hope this study will help determine whether early intervention can delay or prevent memory loss and other symptoms of Alzheimer’s disease.

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

Ongoing Clinical Trials (Not Actively Recruiting)

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.

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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.

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

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.

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia (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.

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

Alzheimer’s Disease Neuroimaging Initiative 4 (ADNI4) Protocol

Individuals have been participating in the ADNI study since its launch in 2004. ADNI is an observational research study, which means it has no study drug or intervention. The ADNI study is designed to look at the relationship between clinical, cognitive, imaging, genetic and biomarker tests to learn more about brain health and the full spectrum of Alzheimer’s disease (AD) from its earliest stages.

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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.

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

A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION717 in Patients with Prion Disease (PrProfile)

The PrProfile study is being conducted by Ionis Pharmaceuticals, a company interested in advancing research for the treatment of prion disease. Prion disease, including Creutzfeldt-Jakob disease (CJD), is a rare and fatal disease that is caused by the misfolding of prion protein. The disease can occur randomly and can be caused by a genetic mutation, or be acquired. Prion disease can cause dementia, psychiatric impairment and motor skill impairment that may lead to serious disabilities and death. The PrProfile study is a clinical study of an investigational drug for people with prion disease. The study can help determine the safety and tolerability of the investigational drug. The study will also help researchers understand how the drug acts in your body and how the body reacts to the drug.

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

Long-term Extension of Phase 3 Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4-LTE)

The purpose of this extension study is to determine if the long-term use of 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 your AD. 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 AD.

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This study is active, but no longer enrolling new participants. For more information, 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.

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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.