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Alzheimer’s Studies and Trials

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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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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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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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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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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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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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