From Washington University School of Medicine in St. Louis:

A worldwide clinical trial aimed at finding treatments for Alzheimer’s disease has expanded to include investigational drugs targeting a harmful form of the brain protein tau. The trial, known as the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) and led by Washington University School of Medicine in St. Louis, launched in 2012 as the first prevention trial for Alzheimer’s disease. Originally focused on amyloid-based therapies, it was funded by the National Institute on Aging (NIA) of the National Institutes of Health (NIH) in 2013.
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“As a platform trial, DIAN-TU plays a critical role in Alzheimer’s prevention by testing a variety of mechanisms,” said Fred Miller, GHR Foundation’s Chief Operating Officer and Alzheimer’s program lead.  “We are excited to join public and private partners in supporting the expanding scope of DIAN-TU as it begins testing tau therapies. Together with DIAN-TU families, we are reimagining what’s possible in our shared goal to prevent dementia caused by Alzheimer’s disease.”

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From The New York Times:

"The study aimed to show that Alzheimer’s disease could be stopped if treatment began before symptoms emerged. The participants were the best candidates that scientists could find: still healthy, but with a rare genetic mutation that guaranteed they would develop dementia.

Now, the verdict is in: The drugs did nothing to slow or stop cognitive decline in these subjects, dashing the hopes of scientists.
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The results are a deep disappointment, scientists said — but not a knockout punch. The drugs did not work, but the problems may be fixable: perhaps the doses were too low, or they should have been given to patients much younger."

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GHR Foundation’s Health initiative partners with organizations pursuing the prevention of Alzheimer’s disease, targeting funding to improve some of the largest research efforts in the field. One such partner is Washington University’s Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU). The DIAN-TU was formed to design and implement prevention trials for dominantly inherited Alzheimer’s disease, caused by a genetic mutation.

This rare form of Alzheimer’s disease results in early-onset of the disease with symptoms starting as early as a person’s 30s and 40s. The DIAN-TU launched a prevention study in this rare population testing experimental drug therapies that may stop the progression of Alzheimer’s disease before symptoms emerge. The trial is currently fully enrolled for the first two drugs and operational in 24 sites across six countries, with interim results expected in 2017 and final results by 2019.

The DIAN-TU builds on Washington University's Dominantly Inherited Alzheimer Network Observational study which collects observational data on persons with these genetic mutations.  The DIAN study is operational in 17 sites across six countries, many of which are also DIAN-TU trial sites.

Washington University is currently planning its DIAN-TU Next Generation trials, which will test two additional potential treatments and novel diagnostic approaches with the dominantly inherited Alzheimer’s disease population. The DIAN-TU project gained attention recently in Germany during the first meeting of German families with the mutations. Attendees were informed about Alzheimer’s clinical trials and the DIAN-TU trials in particular, and had the opportunity to pose questions to researchers. All eligible attendees indicated interest in enrolling in future studies. Given the requirement for multiple sites to meet recruitment goals in this rare population, the participation of the German families is an important step for the DIAN-TU Next Generation Trials.

To learn more about how GHR is joining forces with industry, other philanthropic partners and the United States National Institutes of Health on the prevention of Alzheimer’s disease, contact us. To learn more about the DIAN-TU Study, visit www.dianexr.org or call 1-844-DIAN-EXR (844-342-6397).

GHR Foundation’s Health Initiative is targeting funding to improve some of the largest Alzheimer’s prevention research efforts in the field, including Washington University Medical School’s DIAN-TU Study. This study is quickly evaluating potential prevention treatments among people with a rare genetic trait that causes the onset of the devastating disease in the prime of their lives.

The DIAN-TU Study was recently profiled by PBS’ SciTech Now program, which interviewed Dr. Randall Bateman, Dr. John Morris and a participant of the study. The DIAN-TU segment is the first of three in the 26-minute show, and continues in an interview at the end. This touching and informative profile illustrates not only the science behind the study, but the implications of the disease and what motivates participants.

​To learn more about how GHR is joining forces with industry, other philanthropic partners and the United States National Institutes of Health for the prevention of Alzheimer’s disease, contact us.

GHR’s Health Initiative has committed more than $17 million over 5 years to scaling up important Alzheimer’s disease prevention research already underway. The Foundation is targeting funding to improve some of the largest research efforts in the field, including Washington University's DIAN-TU Study, which is quickly evaluating potential prevention treatments among those who are most likely to develop the disease, and Harvard University's A4 Study, which is working toward FDA approval for prevention therapy in the general population.

A recent Nature article highlights the importance of preclinical treatments, like DIAN-TU, which are initiated in cognitively unimpaired at-risk people, and are intended to postpone, reduce the risk of or completely prevent the clinical onset of Alzheimer’s. The authors argue that we need faster ways to evaluate these treatments, new ways to collaborate towards common goals and determination to expedite preclinical trials.

One useful tool for accelerating the initiation and performance of these trials is Collaboration for Alzheimer’s Prevention (CAP), a convening and consensus-building initiative co-founded by DIAN-TU and A4, among others. Important strides made by CAP include:

• Development of trial outcomes, including cognitive and clinical endpoints and biomarkers
• Standardization of sample and data collection, such as the use of tau imaging in all CAP trials
• Participant recruitment and retention through the development of a registry
• Data and sample sharing mechanisms

​These developments help carry out Alzheimer’s prevention trials with care, thoroughness and maximum impact. ​While all research is uncertain, the potential to turn the tide and provide hope for all families that face Alzheimer’s has never been more promising.  To learn more about GHR’s Alzheimer’s prevention funding efforts, contact us.

GHR Foundation’s Health Initiative is dedicated to a game-changing undertaking—the prevention of Alzheimer’s disease. The Foundation is targeting funding to improve some of the most important research efforts in the field, including Washington University's DIAN-TU Study. This trial focuses on rapid testing of prevention therapies among families that are most likely to develop the disease.
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Recently, DIAN-TU announced it has completed participant enrollment for the first stage of the trial. This enrollment milestone means the first biomarker results will be available at the end of 2016, with the final cognitive endpoint expected in late 2019. This first stage will determine the effects of two drugs targeting amyloid plaques, which are believed by some scientists to be the first step in the process leading to cognitive impairment.

The DIAN-TU team is working with the next generation of innovative drugs and study designs, and expects enrollment for new drugs. To learn more about DIAN-TU and GHR Foundation’s involvement in other innovative Alzheimer’s prevention trials, contact us.

Recently more than 700 Alzheimer’s disease researchers attended the seventh annual Clinical Trials in Alzheimer’s Disease (CTAD) Conference in Philadelphia to discuss new developments in the field. In a press release describing the conference, CTAD described two highlights: new investigational compounds and collaborations for Alzheimer’s prevention.

The latter described the progress made by the Collaboration for Alzheimer’s Prevention (CAP), an umbrella group including two studies funded, in part, by GHR—the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study and the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU).

At the conference, director of DIAN-TU Randall Bateman spoke on the progress of the CAP partnership. Despite differences in populations, the four studies have found common ground on a clear set of cognitive domains to test and compare results. All CAP trials now also plan to use tau imaging, thanks to a partnership between the NIH and 10 industry partners.

CAP’s updates, while notable, are only a portion of the rapidly changing landscape of Alzheimer’s research. Other notable progressions presented at CTAD, such as the new compounds being developed and the creation of the Alzheimer’s Prevention Registry to accelerate enrollment in trials, will intersect with GHR’s Health Initiative’s involvement as organizations and researchers work together to find effective treatment.