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Welcome to the AMYPAD newsletter!

Dear AMYPAD friends,

Frederik Barkhof

We are now half-way through our 5-year project and fully enrolling for both studies, with the Prognostic Natural History Study (PNHS) approaching 100 participants from 5 active sites, hopefully soon overtaking the Diagnostic and Patient Management Study (DPMS) that has surpassed the 300 mark. Early in the fall we estimate the break-even point where both studies will have equal numbers of participants on board. Many new sites are being activated thanks to the hard work of logistic teams – a great team effort!

Hard work is also ongoing to allow non-EPAD cohorts to join the PNHS, with subjects from the twin-cohort of EMIF-AD already being enrolled at VUmc in Amsterdam and the ALFA cohort from BBRC in Barcelona soon to follow. The advantages of these cohorts are that historical PET data are already available, allowing rates of amyloid change to be measured before regular follow-up scans can be acquired in EPAD participants. Challenges exist to merge the data-sets in terms of non-imaging data (e.g. neuropsychology) and several pieces of infrastructure need to be harnessed for this extended scope.

The mandatory quarterly report about recruitment has been favourably received by IMI and the next quarterly report will be prepared shortly to document the enormous amount of activity that has occurred over the last three months. We are finalizing the first amendment to the grant agreement that will reflect many of the necessary changes to accommodate these activities. Meanwhile, work in other work packages is progressing including quantification software and disease modelling.

The fact that AMYPAD is being recognized as an important consortium is well illustrated by the commentary we were invited to write for Lancet Neurology to discuss the publication of the interim results of the IDEAS study in JAMA. That study confirmed the enormous added value in diagnostic certainty of amyloid-PET in a non-randomized study in the US.

Together we will make AMYPAD a success!

This electronic newsletter will be published quarterly and be accessible via the AMYPAD website (www.amypad.eu). In this issue, you will find a reflection on our optimized dual-time window protocol, interviews with two AMYPAD collaborators,  the highlighted achievements over the past quarter as well as AMYPAD’s participation in relevant events.
 

Frederik Barkhof 
AMYPAD Project Coordinator

In the spotlight 

Optimized dual-time-window protocols for quantitative [18F]flutemetamol and [18F]florbetaben PET studies

 
One of AMYPAD’s goals is to understand the prognostic value of amyloid-β PET imaging through an improved understanding of the early disease stages (prognostic study).  In order to answer this question, either a static or dynamic PET acquisition protocol can be used; the first often preferred in large/ multi-center studies. For diagnostic purposes these static scans are sufficient however, the semi-quantitative parameter derived from this scan is known to be affected by changes in scanning time and cerebral blood flow. Given the aim of AMYPAD’s prognostic study, it seems crucial to provide a highly accurate measure of amyloid load through a dynamic acquisition protocol. The downside of such a protocol is its long duration, resulting in lower patient comfort and less efficient scanner and tracer batch usage. An alternative would be a dual-time-window protocol, in which PET data of the early and late phases are acquired separately.

Our recently published paper: “Optimized dual-time-window protocols for quantitative [18F]flutemetamol and [18F]florbetaben PET studies defined the most optimal dual-time-window scanning protocol, by means of a simulation study, for the two amyloid tracers used within AMYPAD. More specifically, the goal was to maximize the resting period (break) and minimize quantification bias...
 
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Meet some of the AMYPAD collaborators

Interview with Ifrah Iidow

I have joined the AMYPAD team in December 2018 and prior to this I was based in Queen Square in London for 8 years working in clinical trials. Now based in Amsterdam, my role in AMYPAD is working as a Clinical Trial Manager on the Prognostic study. In my capacity as a Sponsor representative, I am involved in the set up and activation of sites across Europe in order for them to join AMYPAD...
 
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Interview with José Luis Molinuevo 

I am WP4 lead and that entitles me to be part of the ExCom leadership as well. As a WP4 lead, I am in charge of enabling WP4 to conduct the Prognostic Study. We are making a huge effort right now because we realised that we didn’t have a sufficient number of participants just with EPAD, so we are allowing non-EPAD cohorts to be part of the project...
 
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Highlights of the past quarter

Prognostic and Natural History Study starts in Edinburgh, Barcelona, Toulouse and Geneva
 

During the past quarter, the AMYPAD Prognostic Natural History Study (PNHS) made good progress, activating four additional sites. Submissions are in progress for remaining Wave 1 sites and all Wave 2 sites.

Since the previous newsletter, the PNHS study went from having one active site (VUmc) with 38 subjects accepting to participate and 25 scans performed, to having five active sites (VUmc, UEDIN, BBRC, CHUT, UNIGE). Considering the five active sites together, 175 research participants have already been invited to take part, of which 92 consented. During this last period, great progress was achieved with a total of 72 participants who have been scanned

A major milestone was achieved in early April since both BBRC and UEDIN consented their first participants in the PNHS. The AMYPAD PNHS study also grew with CHUT and UNIGE both activated. The recruitment rate is thus expected to greatly increase over the next months.
 
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AMYPAD around the world

Lisbon, Portugal
26 March 2019


The scientific director of the Alzheimer’s Prevention Program of the Barcelonaβeta Brain Research Center, Dr José Luis Molinuevo, was invited to give a talk at the preconference meeting of the 14th​ International Conference on Alzheimer’s and Parkinson’s Diseases...
 
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Amsterdam, the Nerthelands
28 March 2019


The Amsterdam University Medical Center (UMC) hosted their second event for all EPAD participants and study partners. Representing the AMYPAD project during the event, researcher...
 
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Geneva, Switzerland
15-17 May 2019


The EPAD Academy session organised during the EPAD General Assembly meeting was a great opportunity for presenting AMYPAD...
 
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Upcoming event

 
- BRAIN & BRAIN PET 2019
4-7 July 2019, Yokohama (Japan) 
 
- The Alzheimer’s Association International Conference (AAIC)
14-18 July 2019, Los Angeles (US)

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Acknowledgement.
The project leading to this application has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115952. This Joint Undertaking receives the support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

Disclaimer
This newsletter reflects the views of the AMYPAD Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.
Copyright ©2017 AMYPAD, All rights reserved.

Our mailing address is:
info@amypad.org


 






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