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Changing the future of clinical trials in Alzheimer’s disease

EPAD is pioneering a new approach to clinical trials of drugs designed to prevent Alzheimer’s disease.

Alzheimer’s disease is a progressive degenerative disease that results in a loss of brain cells. It is the most common form of dementia in the elderly. According to the World Alzheimer Report 2016, there were 46.8 million people worldwide living with dementia in 2015 and this number will reach 131.5 million in 2050.

While there is no cure for Alzheimer’s disease, the U.S. Food and Drug Administration (FDA) has approved two types of medications – cholinesterase inhibitors (Aricept, Exelon, Razadyne) and memantine (Namenda) – to treat the cognitive symptoms of Alzheimer’s disease. However, despite intensive efforts over many years and significant global investment, no new drugs have been approved since 2003.

Prevention of Alzheimer’s dementia

There is now compelling evidence that Alzheimer’s disease takes hold in the brain decades before dementia symptoms appear, providing a window of opportunity for preventative intervention. As a result, today’s research increasingly focuses on this pre-symptomatic phase, with the aim of delaying or preventing the disease.

The European Prevention of Alzheimer’s Dementia (EPAD) consortium was an interdisciplinary research initiative aiming to improve the understanding of the early stages of Alzheimer’s disease and deliver new preventative treatments.

The largest ever public-private partnership in Alzheimer’s disease research, EPAD transcended disciplinary boundaries to combine knowledge and expertise from 39 European partner organisations across multiple sectors.

Early, targeted intervention

Research has established beyond doubt that Alzheimer’s dementia is a result of multiple disease processes. By the time symptoms appear, numerous pathologies have hampered brain function.

The hypothesis behind EPAD suggested that early, targeted intervention focused on the very first stages of disease will be more successful. This approach requires greater insight into the life of the brain than has ever been achieved before. Which disease processes are most relevant? What is the interaction between risk factors, disease and intervention? How do you find the right people to track over time? EPAD was set up to find the answers.

Tackling the challenges

EPAD faced a number of challenges, including the difficulty of identifying people who are likely to develop Alzheimer’s dementia, the poor understanding of the earliest stages of the disease, and a lack of flexibility in the way clinical trials are carried out.

To address these issues, we developed three core strategies which deliver benefits for intervention owners and research participants.

  1. The Register: EPAD has created the first single, pan-European register of over half a million people across the risk spectrum for dementia.
  2. The Cohort: From this register, research participants were invited to join an EPAD cohort of at-risk subjects, the Longitudinal Cohort Study, known as the LCS. This group underwent standardised tests and follow-up over several years.
  3. The Trial: EPAD was aiming to select participants to take part in streamlined proof-of-concept (PoC) trials of drugs designed to prevent Alzheimer’s dementia.

Watch the EPAD video for an overview of our approach.

Pioneering adaptive trials in Alzheimer’s dementia

The case for using adaptive trials as a methodology to research dementia is strong. With better data and improved decision-making, adaptive trials can increase the probability of success and decrease development time. EPAD is pioneering this approach in Alzheimer’s disease.

In traditional clinical trials, half of the participants receive the drug under investigation, and half receive a placebo. In adaptive clinical trials, several candidate drugs are simultaneously compared to each other and to a placebo, meaning that a greater proportion of patients benefit from a potentially active treatment. Furthermore, researchers can adapt the trial design in response to emerging results, new candidate drugs can be added, and those that prove ineffective can be dropped.

By setting up a trial-ready cohort of research participants, creating a pan-European network of trial sites, identifying ineffective medicines earlier in the development process and eliminating failures in more advanced (Phase III) trials, EPAD aimed to accelerate the development of effective therapies.

Please read more about EPAD’s platform for intervention owners.

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📢@imi_epnd has launched its Cohort Catalogue, a central, open & accessible repository for researchers to discover studies & search metadata. Currently 67 research cohorts from 17 countries across Europe including @IMI_EPAD-VUmc participants ⬇️ eurekalert.org/news-releases/… twitter.com/imi_epnd/statu…

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NEW paper published in @MetabolitesMDPI using LC-MS/MS method to determine salivary steroids using @IMI_EPAD samples. Congratulations @GregorySarah @zinghomer @guider50 @scottgdenham👏 @EdMassSpecCore @IMI2_NEURONET @IHIEurope #mdpimetabolites mdpi.com/2133518

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"There is a growing consensus that individual research results that are potentially relevant should be reported to research participants” & “Our work was positively received by the EPAD partners, and formed the basis for the set-up & the conduct of the study,” said Eline Bunnik

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10:32 am · 2023-01-31
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Have a look on the @IHIEurope newsletter including a spotlight on IMI results from projects on diabetes @HypoResolve and #Alzheimer’s disease @IMI_EPAD @IMI_AMYPAD ⬇️ Read it: bit.ly/3jeaxdM twitter.com/IHIEurope/stat…

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17 centres have contributed to the @IMI_AMYPAD Prognostic Study across 11 Parent Cohorts including @IMI_EPAD. Have a look on the latest AMYPAD paper published in @FrontNeurol ⬇️ twitter.com/IMI_AMYPAD/sta…

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  • Analysis of multiple steroids in saliva in the EPAD study
  • Hormone Replacement Therapy could ward off Alzheimer’s among at-risk women
  • Associations between Mediterranean diet and cognition in the pan-European EPAD LCS
  • Interview with Dr. Bruno Steinkraus, Chief Scientific Officer at Hummingbird Diagnostics GmbH
  • New paper defining and discussing the substantial assets of the EPAD project is out!
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This work has received support from the EU/EFPIA Innovative Medicines Initiative Joint Undertaking EPAD grant agreement nº 115736

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