Alzheimer’s Studies and Trials

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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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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 6-month, open-label extension study.
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Synaptic Therapy Alzheimer’s Research Trial

This study will investigate whether CT1812, a novel and promising therapeutic candidate can halt or slow the process of Alzheimer’s disease. In 2022, a nationwide randomized controlled clinical trial will enroll approximately 540 individuals from Alzheimer’s Clinical Trial Consortium (ACTC) sites and sites from other partnering institutions. 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), will be 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. This study will leverage the centralized resources, shared expertise, and experienced trial sites of the ACTC to investigate the potential of CT1812 to preserve cognitive function for individuals with early Alzheimer’s disease.
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A4 Open Label Extension

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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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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