ENDING ALZHEIMER’S
BEFORE ANOTHER
GENERATION IS LOST
ALZHEIMER’S PREVENTION INITIATIVE

The Alzheimer’s Prevention Initiative (API) was established to launch a new era in Alzheimer’s prevention research, accelerate the evaluation and approval of prevention therapies, and find ones that work as soon as possible.

API is led by researchers from Banner Alzheimer’s Institute (BAI) in partnership with leaders from academia, industry, and other public and private stakeholder organizations around the world. It is supported by competitive research grants from the National Institute on Aging (NIA), generous philanthropic contributions to Banner Alzheimer’s Foundation, and partnerships with pharmaceutical companies.* It is intended to provide the best fighting chance to find and support the approval of an effective Alzheimer’s prevention therapy by 2025, and to set the stage for the continued evaluation of prevention therapies after that time.

API projects and programs have received generous support from NIA grants RF1 AG041705, UF1 AG046150, R01 AG031581, R01 AG055444, and P30 AG19610; collaborative research agreements with Genentech/Roche, Novartis, Amgen and Avid/Eli Lilly; philanthropic support from Banner Alzheimer’s Foundation, Alzheimer’s Association, FBRI, FIL Foundation, Flinn Foundation, Forget Me Not Initiative, GHR Foundation, the NOMIS Foundation; Colciencias grants 1115-408-20512, 1115-408-20543; and the Arizona Alzheimer’s Consortium.

PREVENTION TRIALS

API has introduced ground-breaking research paradigms, cognitive and biomarker assessment tools, and Alzheimer’s prevention trials.

It includes the first funded prevention trial of an investigational anti-amyloid drug and a growing number of precedent-setting prevention trials in cognitively unimpaired people at high genetic and/or biomarker risk. API consists of:

  • The API Autosomal Dominant Alzheimer’s Disease (ADAD) Colombia Trial is studying the use of an anti-amyloid treatment crenezumab in cognitively unimpaired E280A mutation carriers and non-carriers from the world’s largest ADAD kindred (clinicaltrials.gov  NCT01998841). Mutation carriers are at virtually certain risk for developing AD at younger ages. The study is led by BAI, the University of Antioquia in Colombia, Genentech, and its parent organization Roche.
  • API Generation Program is made up of two clinical trials – Generation Study 1 and Generation Study 2 – and is testing investigational study medications aiming CAD106 and CNP520 which aim to prevent or delay the onset of symptoms associated with Alzheimer’s disease in cognitively healthy people whose genetic makeup puts them at particularly high risk for developing the disease (clinicaltrials.gov  NCT02565511 and NCT03131453).  These international studies are part of a collaboration between BAI, Novartis, Amgen, and the NIA.

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  • Additional prevention trials to come.

API has established precedent-setting public-private partnerships, surrogate biomarker development strategies, and biological sample sharing programs to conduct prevention trials with optimal public benefit.

RECRUITMENT REGISTRIES

API has developed exceptionally large registries and genetic and biomarker-testing programs to support awareness, interest and participation in prevention trials, including:

  • The Alzheimer’s Prevention Registry is a global resource to help advance Alzheimer’s research by connecting scientists with an engaged online community of volunteers age 18+. Nearly 80 percent of research studies fail due to challenges to recruit enough people, and the Registry is playing a crucial role in establishing a large, diverse community to support Alzheimer’s-related studies.

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  • GeneMatch is accelerating research recruitment by matching healthy volunteers aged 55-75 in the United States to Alzheimer’s prevention studies, based in part on their genetic profile. The innovative program will help researchers not only fill their studies faster, but also achieve study milestones sooner.

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Additionally, under the leadership of API’s partners at the University of Antioquia, the Colombian API Registry has conducted clinical assessments and genetic tests in about 6,000 members of the PSEN1 E280A kindred, about 1,200 of whom carry the PSEN1 E280A mutation which causes them to develop cognitive impairment at the average age of 45.

TRIAL DATA

In 2012, API established a precedent-setting agreement with Genentech and its parent organization Roche to share data and biological samples from the API ADAD Colombia Trial after the prevention trial is over. API subsequently established similar data and biological sample sharing agreements with Novartis and Amgen to share data and biological samples from the Generation Program.

In 2016, API researchers, along with their colleagues from the Collaboration for Alzheimer’s Prevention (CAP), developed data and sample sharing principles for baseline and post-randomization data, such that trials can be performed in ways that will have the greatest public benefit (Weninger et al, 2016). API intends to embrace these principles in all of its trials.

Baseline Data Requests

Investigators can apply for use of baseline demographic, clinical, and imaging data from the API ADAD Colombia Trial as soon as these data are uploaded to API’s data-sharing portal. Until then, investigators may send data queries to APIdata@bannerhealth.com.

LEADERS AND PARTNERS

API is led by Eric M. Reiman, MD, Pierre N Tariot, MD, and Jessica Langbaum, PhD, at BAI.  The API ADAD Colombia Trial is also led by Dr. Francisco Lopera from the Neurosciences Group at the University of Antioquia. API’s prevention trials have benefitted from partnerships with its industry partners and the NIA.  Its progress and productivity would not be possible without the critical contributions and leadership efforts of numerous colleagues and collaborators, and without the commitment and generosity of our valued research participants.

CONTACT US
For General Inquries:
1-888-STOP-ALZ (1-888-786-7259)
 
For Media Inquries:
602-492-4770
The Alzheimer’s Prevention Initiative