What it takes to launch a world-scale Alzheimer’s study

There are 100+ researchers, 19 different organisations, 8 different sites and a fearless team conducting it all. Alzheimer’s research today has got so much bigger in its detail and scope. In this blog, Tony, Trial Coordinator of the Deep and Frequent Phenotyping study, gives the inside track on what it’s like to be part of such ambitious research.

"It’s like being surrounded by 30 spinning plates and your job is to make sure none of them fall.” I gulped. I was in my first 1:1 meeting with my new manager, Jen Lawson. I wasn’t really scared though; I was pretty excited. I’d just started work with the central team who are coordinating a gigantic study into early-stage Alzheimer’s disease. The aim – to identify the elusive earliest stages of the disease – addresses one of the most urgent research questions in the field. Researchers need to know what’s happening early on in Alzheimer’s so that they can start testing treatments and preventions at much earlier stages. The reality of making this study happen is like nothing I’ve experienced in my working life before.

I’ve worked in dementia research for five years. At Imperial College London, I’ve worked on interventional trials – working with companies to test new medications – and observational trials. Typically, I’d be coordinating studies with 50 people, analysing the results of just one type of brain scan. None of the trials I worked led on to drug development. Many people outside my field will know that there have been a number of recent high-profile drug trial failures too.

The Deep and Frequent Phenotyping study (DFP) is the most detailed study into preclinical Alzheimer’s disease that I know of. It aims to address the recent failures of clinical trials by creating a database of different measures from people at risk of Alzheimer's disease. This includes regular brain scans, cognitive and memory testing, eye scans, blood tests and the use of wearable technology to measure movement and how people walk. Compared to what’s usually done, this is huge! In the future we will be able to use the data obtained through DFP to understand if early interventions are working.

Bringing this enormous study to life takes a lot of cooperation, and collaborations with many different people. So how are we doing it?

Our study bible

It starts with the protocol, which many believe to be the bible of the study. The protocol is like a manual of all the methods we researchers will use in the study. Every clinical trial has a protocol. If you run clinical trials, you’ll know they’re like the bread and butter of our job.

Because DFP involves so many different tests, bringing the entire study protocol together has been a massive task. Experts in PET, MEG, MRI, bio sampling, ophthalmology, gait assessment, smart phone applications, wearable technologies and cognitive assessments have all been involved. In such a fast moving field as Alzheimer’s research, methods are continuously being developed and refined. We are working with experts at the forefront of their fields so our protocol reflects that.

We’ve taken care to schedule all the tests so that none affect each other. We also need to make sure that they are all completed within our one year of study. This is so that we’ll be able to pick up the subtle changes in the disease development. It’s this very frequent testing which is what makes DFP so important but also so challenging for a trial coordinator!

Participant information

Once the protocol is finalised and all investigators are happy with it, it is up to the trial manager to figure out what needs to be done before the study can actually start. Very often, it’s the participant-facing documents that we work on next. This includes information sheets, consent forms and advertising copy. All these documents are then sent to the Research Ethics Committee, or REC for short. REC is the organisation that exists to safeguard the rights, safety, dignity and wellbeing of research participants. It’s extremely important. Once the REC have given their approval, it is then up to the trial manager to put the necessary contracts and site agreements in place.

Site set up

All of the DFP tests require special equipment of some sort or another. We need to be sure that all the sites are ready – this means having the right infrastructure, equipment and training for the local research assistants who’ll be carrying out the tests. Now that we’ve established the protocol for the study, we are at this final stage of site set up – making sure that everyone involved is using the methods that will provide the scientists with the most detailed data on the earliest stages of Alzheimer’s disease.

With a study like DFP, there are so many moving parts – I’ve got to keep my 30 plates in the air! What it really takes is dedication to the cause, cooperation and a great team of colleagues. Luckily we have all of that.

The DFP study will launch in summer 2019. If you are interested in taking part as a research participant, please register on www.dfpstudy.co.uk. For further updates on the study progress and activity across the different sites see here.