Studies

Thank you for your interest in volunteering for one of the University of Southern California Alzheimer’s Therapeutic Research Institute (USC ATRI) coordinated studies.

To participate, please find a trial that is right for you (or someone you love) and contact a clinical site near you. Each of our studies have different eligibility criteria.  While not everyone can join a trial, you can always become an advocate by sharing the trials with someone you know who might be able to participate.

To watch an informational video about why your participation in clinical trials is so important, click here.

We appreciate your support as we seek to prevent and treat Alzheimer’s disease.

Active Studies – Recruiting

Alzheimer’s Disease Neuroimaging Initiative logo
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.  ADNI3 will include 600 new participants age 55-90 and 600 rollover participants from ADNI2.

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Alzheimer Prevention Trial Webstudy logo

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.  APT Webstudy participants benefit by:

  • Having their cognitive health assessed over time;
  • Being on the ‘fast track’ for relevant clinical trials to prevent Alzheimer’s;
  • Making an invaluable contribution to advancing Alzheimer’s research, perhaps helping those in the research field find the first Alzheimer’s survivor; and
  • Helping ensure that future generations do not experience Alzheimer’s and its difficult challenges.

The APT Webstudy is being conducted by the University of Southern California Alzheimer’s Therapeutic Research Institute (USC ATRI), funded by the National Institute on Aging (NIA), and is non-interventional.

To participate in the APT Webstudy or to learn more, please visit www.aptwebstudy.org. Those identified from the APT Webstudy to have a potential increased risk for memory loss will be referred to participating TRC-PAD (below) site locations.  You do not have to participate in the TRC-PAD in-person study to participate in the online APT Webstudy.  Participants have the option of participating in either English or Spanish.

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DOD ADNI STUDY logo
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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The LEADS study

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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mind-study logo

The purpose of the Memory Improvement Through Nicotine Dosing (MIND) study is to determine whether daily transdermal nicotine (patch) will have a positive effect on early memory impairment in participants diagnosed with Mild Cognitive Impairment (MCI).  We are looking for healthy, non-smoking adults, age 55+.

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Alzheimer Prevention Trial Webstudy logo

Those identified to have a potential increased risk for memory loss caused by Alzheimer’s disease, will be 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 is to find as many people as possible (also called a “cohort”) who are interested in participating in clinical trials aimed at discovering treatments that will reduce the risk of developing Alzheimer’s dementia. TRC-PAD will help researchers enroll participants into these trials quickly to allow new treatments to be discovered as soon as possible.  Participants do not have to participate in the TRC-PAD study in order to participate in the online APT Webstudy.

TRC-PAD is being conducted by the University of Southern California Alzheimer’s Therapeutic Research Institute (USC ATRI), funded by the National Institute on Aging (NIA), and is non-interventional.

To get involved with the TRC-PAD in-person study, please register and participate in the APT Webstudy first at www.aptwebstudy.org.  Those identified from the APT Webstudy to have a potential increased risk for memory loss will be referred to participating TRC-PAD site locations.

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Active Studies – Not Yet Recruiting

AHEAD 3-45

AHEAD 3-45 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.

AHEAD 3-45 combines two studies with distinct participant groups but with common screening and recruitment to increase efficiency. More details on each study can be found on the study website.

We anticipate enrollment for AHEAD 3-45 to begin in the first half of 2020. One way to take steps toward participating in AHEAD 3-45, is to enroll in the Alzheimer Prevention Trials (APT) Webstudy today. The APT Webstudy aims to identify participants who may be good future candidates for AHEAD 3-45. Information on how to register for the APT Webstudy can be found above.

Learn more: https://www.a3a45.org/.

Trial-Ready Cohort- Down Syndrome (TRC-DS)

The Trial-Ready Cohort- Down Syndrome (TRC-DS) aims to enroll 120 non-demented adults (ages 35-55) 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.

Active Studies – Not Recruiting

The A4 Study logo
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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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.

The ADNI Depression Project
The ADNI-Depression Project (ADNI-D) enrolled 120 participants who were experiencing symptoms of depression. The goal of the study is to determine whether imaging of the brain can help predict the onset and monitor the progression of cognitive change.
For more information, click here.

Studies – Completed

The Connect study
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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Studies – Closed

The EARLY study
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).

Elevations of liver enzymes, which were serious in nature, were observed in some study participants who received the Janssen BACE inhibitor, atabecestat. After a thorough evaluation of all available liver safety data from their studies, Janssen concluded that the benefit-risk ratio was no longer favorable to continue development of atabecestat for people who have late-onset preclinical stage Alzheimer’s disease.

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The SNIFF study
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).

“We call the condition of memory impairment alone amnestic Mild Cognitive Impairment (aMCI),” says Dr. Ronald Petersen, director of the NIA-funded Mayo Alzheimer’s Disease Research Center.  “Researchers are particularly interested in the brain changes and memory loss of aMCI, because more people with this condition go on to develop AD than do people without it. We don’t yet know for sure whether aMCI is a separate condition or a transitional stage between normal aging and AD.”

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