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Alzheimer’s Studies and Trials

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Apex study
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APEX Study

The Alzheimer’s Plasma Extension (APEX) Study is a multicenter, observational study on Alzheimer’s disease (AD) related brain changes being conducted by Brigham and Women’s Hospital and University of Southern California (USC). An observational study is where researchers look at (or observe) changes over time without any study treatments. In this study, researchers will look at changes in blood tests, memory, and other factors that may predict who will accumulate brain amyloid over time, as well as factors that may help preserve memory and thinking in older individuals who do not develop elevated amyloid levels. The APEX Study consists of one in-person visit every year for four years in which blood samples, memory tests and questionnaires will be collected. Participation in this study will help researchers identify changes in blood tests, memory, and brain health that may occur years before people develop elevated brain amyloid and cognitive impairment and inform future clinical trials for Alzheimer’s disease.
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Trial-Ready Cohort- Down Syndrome (TRC-DS)

The Trial-Ready Cohort- Down Syndrome (TRC-DS) aims to enroll 450 non-demented adults (ages 25-55) with Down syndrome (DS) into a trial ready cohort (TRC). Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer’s disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression.
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Longitudinal Early-Onset Alzheimer’s Disease Study (LEADS)

The LEADS study – or the Longitudinal Early-Onset Alzheimer’s Disease Study (LEADS) explores the development of early-onset Alzheimer’s disease and how it compares to the more common late-onset Alzheimer’s disease. Better understanding of this form of the disease may ultimately lead to more effective treatments. LEADS is a 2-year observational study designed to enroll 500 participants. Researchers are also recruiting cognitively normal volunteers for a 1-year comparison.
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Alzheimer Prevention Trials (APT) Webstudy

If you are 50 years of age or older, you can monitor your own cognitive health by participating in the Alzheimer Prevention Trials (APT) Webstudy. The APT Webstudy is designed to identify people who may have an increased risk for developing Alzheimer’s disease, using the latest technology to monitor their cognitive performance through regular online memory testing. Volunteers of the APT Webstudy participate at their convenience, anywhere they have access to the internet. If you are interested in the AlzMatch Study, it is currently on a hiatus.  If you would like to be considered for the AlzMatch Study in the future, please begin participation in the APT Webstudy.  Future invitations to AlzMatch will go out to eligible APT Webstudy participants.
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Synaptic Therapy Alzheimer’s Research Trial

This study is investigating whether CT1812, a novel and promising therapeutic candidate can halt or slow the process of Alzheimer’s disease. The START Study is a nationwide clinical trial and will enroll approximately 540 individuals. Participants aged 50 to 85 with mild cognitive impairment (MCI) due to Alzheimer’s disease, or mild Alzheimer’s disease who have elevated amyloid in the brain (as measured by PET or CSF), are sought. Participants will be randomized to receive CT1812 or placebo for 18 months. In addition to a battery of cognitive measures, the study will use a variety of biomarkers to evaluate target engagement and assess changes in neurodegeneration and disease progression.
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Alzheimer’s Disease Neuroimaging Initiative (ADNI)

The Alzheimer’s Disease Neuroimaging Initiative (ADNI), a landmark study that began in 2004, is a public-private research partnership tasked with identifying biomarkers to detect Alzheimer’s disease (AD). The study has gathered and analyzed thousands of brain scans, genetic profiles and biomarkers in blood and cerebrospinal fluid (CSF) and was designed to enable researchers to follow AD as it progresses in an individual, from various points in the disease process. The newest iteration of the study, called ADNI4, aims to recruit 750 new participants age 55-90 and bring over 750 rollover participants from ADNI3.
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Actively Enrolling
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Life’s End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY)

Approximately fifty percent of people diagnosed with Alzheimer’s disease or other types of dementia will receive hospice care at the end of their life. Of these, over seventy percent will be prescribed psychiatric medications for management of agitation. Recent research suggests that derivatives of cannabis can be beneficial in controlling agitation and distress without the side effects of medications commonly used to treat agitation. This project aims to test the efficacy of an oral combination of two cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD), for the treatment of agitation in participants with a diagnosis of dementia who are eligible for hospice and experiencing agitation. The study will recruit 150 participants from 15 clinical trial sites in the United States over a 2-year period. To facilitate recruitment and retention and to monitor long-term safety of the THC/CBD combination, completers of the double-blind study will then have the option to participate in a 3-month, open-label extension study.
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Active – Coming Soon
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Alzheimer’s Tau Platform (ATP) Study

Tau protein is an important target in Alzheimer’s disease (AD), and there is now strong evidence that tau in brain is closely linked to worsening of cognition and other symptoms. The Alzheimer’s Tau Platform (ATP) Study is a multicenter clinical trial to determine the safety, tolerability and biological proof of at least two different tau-directed therapies. It is being designed and conducted by the Alzheimer’s Clinical Trials Consortium (ACTC) through a public-private partnership with the National Institute on Aging (NIH) and industry collaborators.  It is being led by two academic principal investigators: Dr. Adam Boxer from the University of California, San Francisco and Dr. Keith Johnson from Massachusetts General Hospital and Harvard Medical Center.
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Screening Closed
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AHEAD Study

AHEAD Study is a global multicenter clinical trial aimed at preventing memory loss due to Alzheimer’s disease, designed and conducted by the Alzheimer’s Clinical Trials Consortium (ACTC) in collaboration with Eisai. Funding is through a public-private partnership with National Institute on Aging (NIH), Eisai, and several philanthropic organizations. It is led by three academic principal investigators: Dr. Paul Aisen from University of Southern California, and Drs. Reisa Sperling and Keith Johnson from Brigham and Women’s Hospital and Massachusetts General Hospital, Harvard Medical School.
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Completed
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The LEARN Study

The LEARN study was funded by the Alzheimer’s Association to support the Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) study. The LEARN study is a companion study to the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4) study, a pioneering Alzheimer’s secondary prevention trial.
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Completed
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A4 Study

The landmark Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (A4 Study) enrolled 1,169 healthy older adults with normal memory but who might be at risk for Alzheimer’s due to family history of the disease and elevated levels of amyloid plaque in the brain. The primary study aims are to prevent the memory loss associated with the disease.
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Completed
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SNIFF

The purpose of the SNIFF study is to find out whether a type of insulin, when administered as a nasal spray, improves memory in adults with a mild memory impairment or Alzheimer’s disease (AD). The study enrolled 250 adults, age 55-85 who were diagnosed with amnestic mild cognitive impairment (aMCI) or early AD. There were 26 clinical sites involved. Scientists have learned that MCI has several subtypes. In the most common subtype with high probability of progression to Alzheimer’s disease, memory loss is the most prominent feature (other types of MCI feature other types of cognitive problems).
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Completed
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Connect

The Connect study tested whether an oral, experimental drug, AZD0530 (saracatinib), would slow progression in early stage Alzheimer’s disease (AD). In its early stage after the medical diagnosis of Alzheimer’s disease, patients typically show some memory loss, but a majority of daily functions are intact, requiring some reminders or help organizing the day from others in the household. The University of Southern California, Alzheimer’s Therapeutic Research Institute served as the coordinating center, helping to enroll 159 participants at 23 clinical sites across the United States.
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Completed
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DOD ADNI

The purpose of DOD ADNI is to examine the possible connections between Traumatic Brain Injury (TBI) and Posttraumatic Stress Disorder (PTSD), and the signs and symptoms of AD on Veterans as they age. Approximately 300 Vietnam War Veterans, ages 50-90 will be eligible to participate in this study
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Closed
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EARLY Trial

The EARLY Trial was looking to determine the Efficacy and safety of atabecestat in participants who are Asymptomatic at Risk for developing Alzheimer’s dementia. The study sponsor, Janssen, sought to use the latest advances to assess a participant’s risk associated with beta-amyloid and memory loss, and test whether a treatment that reduces amyloid formation would slow memory loss associated with Alzheimer’s disease (AD).
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Completed
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Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD)

Those identified to have a potential increased risk for memory loss caused by Alzheimer’s disease were referred from the APT Webstudy (above) to the Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD) in-person study. The purpose of TRC-PAD was to find as many people as possible (also called a “cohort”) who were interested in participating in clinical trials aimed at discovering treatments to reduce the risk of developing Alzheimer’s dementia. TRC-PAD sought to help researchers enroll participants into these trials quickly to allow new treatments to be discovered as soon as possible.
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