IXICO & GAP Foundation: Alzheimer’s & The Bio-Hermes Study

Lynne GAP Interview

Interview with IXICO & GAP Foundation: Alzheimer’s Disease & the Pioneering Bio-Hermes Study

Alzheimer's disease is an irreversible, progressive brain disorder that accounts for about 50–75% of all cases of dementia. It’s a growing problem. The USA saw a 145% increase in Alzheimer’s disease-related deaths between 2000 and 2018. Alzheimer’s disease and dementia-related deaths have increased by 16% during the COVID-19 pandemic.

There is also a rising cost of treating the disease. In 2021 Alzheimer’s disease cost the US $355 billion, and this is set to rise to $1.1 trillion by 2050 if this remains unabated.

Unfortunately, the timely and efficient conduct of clinical trials is hampered by challenges in comparing data sets and validity of cognitive testing.

To address these challenges, the Global Alzheimer’s Platform (GAP) was founded. GAP is a patient-centric, non-profit organization dedicated to speeding up the delivery of innovative dementia therapies by reducing the time and cost of Alzheimer’s disease clinical trials.

In this interview Lynne Hughes, Clinical Development Advisor at IXICO, and John Dwyer, President of GAP, describe how they came to work together on the pioneering Bio-Hermes trial, and how their combined technologies are changing the face of Alzheimer’s disease research for both patients and pharma companies.

Here, we summarize the key points.

The GAP & IXICO Partnership

Alzheimer's disease trials are some of the most difficult in the world to conduct.

Lynne has worked in the pharma industry for the last 35 years, including 23 years leading neurology clinical trials. Over the last decade, she has managed and overseen more than 125 global trials in Alzheimer’s disease, as well as working as a consultant to IXICO looking at their therapeutic strategy and development. Lynne acts as a bridge between GAP and IXICO, with the aim to expedite clinical trials for Alzheimer’s disease so that a cure for the disease can be found more quickly.

IXICO and GAP began working together when GAP required a specialist partner for a clinical trial to assess blood plasma biomarkers. As experts in the field, we were able to provide a therapeutic “gold standard” in Positron Emission Tomography (PET) brain imaging, as well as a central PET imaging reader, that could demonstrate the likelihood of Alzheimer’s disease in a patient.

We are now applying our expertise to collect PET brain scans in qualifying imaging centers as a key element of GAP’s innovative Bio-Hermes trial. The collaboration has also committed to ground-breaking levels of minority participation so that future treatment breakthroughs can benefit everyone impacted by Alzheimer's disease.

What is the Bio-Hermes Study?

The Bio-Hermes study endeavors to quickly understand how biomarkers and digital cognitive tests could be evaluated relative to a common, ubiquitously understood standard. 

GAP created a “head-to-head” comparison across ten different cognitive tests, including retinal, speech, analytics and blood plasma. The results of this will make it faster and more accurate to characterize the cognitive condition.

The study’s goal is to report to the field in an unbiased way how these various tests perform against a common standard. The result will be a consumer-friendly, information-based effort to be able to compare and contrast the efficacy of a broad variety of tests.

The impact of the Bio-Hermes Study for pharma

Current Alzheimer’s disease clinical studies recruiting amyloid-positive subjects have a screen failure rate of around 85%. This means that for every 100 subjects screened for their suitability to take part in a trial, 85 fail to meet the requirements.

This costs pharma companies hundreds of millions of dollars in screening tests and prolongs the time it takes to get a drug to market because a critical mass of suitable subjects must be found before a trial can proceed.

“For every 100 subjects that are screened for their suitability to take part in a trial, 85 fail to meet the requirements. This is costing pharma companies hundreds of millions of dollars in screening tests, and taking time to get a drug to market.”

The core aim of the Bio-Hermes study is to decrease screening failure rate and increase recruitment rate, thereby allowing subjects to be recruited to Alzheimer’s disease clinical trials more quickly.

If screen failure rate could be reduced to 40% instead of 85% (or higher), the result will be a significant expedition of drug development for Alzheimer’s disease. Therefore, it is in everyone’s interest to hit this target.

The important role of imaging in the Bio-Hermes study

PET imaging is currently considered the gold standard for identifying amyloid – the plaques that cause Alzheimer’s disease – in the brain. By detecting amyloid levels in subjects through imaging, it’s possible to tell if the patient is a suitable candidate for a drug that attacks it.

IXICO is providing the central reads for PET imaging for all 1,000 subjects in the Bio-Hermes study. This creates a consistency of regions and homogeneity of data, leading to a gold standard test against which all other tests can be assessed.

Why did GAP Foundation choose IXICO as its imaging partner?

John’s main reasons for selecting us to work with GAP on the Bio-Hermes trial were:

 

  1. Following a side-by-side comparison of the leading candidates in this area, IXICO demonstrated far and away the most interest in the study and developed a program that was well designed to be customer-friendly to everyone undertaking the study.
  2. IXICO had the expertise to be able to bring the leading scientists of the field into the central reading process. Given this is an incredibly niche area, IXICO were able to bring in high quality, scientific excellence to review the images.
  3. Great relationships between the GAP and IXICO teams, who share the same commitment to reducing the time, cost, and risk for Alzheimer's disease trials.

How will the Bio-Hermes trial impact the future development of Alzheimer’s Disease therapies and clinical trial planning?

The core benefit of this trial is that all sponsors, whether they are research centers or conducting commercial therapeutic trials, will have access to a vast array of tools that can make each one of their trials better.

The trial will also allow GAP to look at new therapies targeting other proteins present in later-stage Alzheimer’s disease cases. The newly developed blood tests would then pave the way for more therapies that would be much faster in their administration.

“The core benefit of this trial is that all sponsors, whether they’re research centers or conducting commercial therapeutic trials, will now be able to see a whole array of tools that can make each one of their trials better.”

Global expansion

In conjunction with IXICO, The GAP Foundation is currently expanding into Europe, with 24 clinical trials sites. Ten of those sites are in the UK – four in Scotland and six in England. GAP plans to aggressively grow this number to reach 30 trial sites later this month.

Find out more

With our specialist neuroscience knowledge, AI-driven innovation and robust operational infrastructure, IXICO solutions are specifically designed to enable sponsors to address core challenges and realize the full power of imaging biomarkers in their CNS clinical trials.

Click here to find out more about our neuroscience expertise and neuroimaging for CNS trials.


Date: 02/03/2022