Can the GAP model reduce the time and cost of AD clinical trials?

8th December 2017 (Last Updated December 8th, 2017 09:46)

Alzheimer’s disease (AD) is a progressive neurodegenerative disease that is characterised by memory loss, cognitive impairment, and functional decline.

Alzheimer’s disease (AD) is a progressive neurodegenerative disease that is characterised by memory loss, cognitive impairment, and functional decline.

During the development of AD, degeneration of neurons starts in the brainstem before progressing to the hippocampus, frontal lobe, amygdala, parietal lobe, and temporal lobe. The cause of AD is not known, but appears to be multifactorial, with most research aimed at the amyloid beta (Aβ) peptides and tau proteins. The irregular clearance and metabolism of these proteins are likely contributors to the presentation of the disease.

With a rapidly accelerating worldwide prevalence, AD has been identified as a major global health threat by the international medical community, and costs US taxpayers more than $153B per year in medical expenses and Medicare spending.

Combatting bottlenecks

There is currently no cure for AD, as conducting successful clinical trials in this field have proven to be extremely challenging. The current bottlenecks in AD clinical research are difficulties in identifying and enrolling new patients, as well as a high screen failure rate, with 85% of trials being delayed due to enrollment issues and more than 30% of total trial time spent just on recruiting. As such, the Global Alzheimer’s Platform (GAP) Foundation has developed a new model to accelerate drug development through the establishment of a trial-ready cohort, which will facilitate enrollment into preclinical and prodromal AD cognitive endpoint trials (TRC PAD) and increase patient participation in clinical research.

To achieve this goal, GAP’s new methods will aim to reduce the clinical trial cycle times by up to two years through the optimization of trial registration and cohort selection via operational measures with establishing systems and registries connected to the GAP registry, the optimisation of the transition from GAP registry to GAP cohort, shortened time to site activation trials, markedly accelerated recruitment, and improved retention in clinical trials. Moreover, GAP’s scientific measures include internet-based mechanisms populating an in-person, trial-ready cohort that can attract and maintain potential participants for preclinical and prodromal AD trials. This is especially important for AD, as no new AD drugs have been approved for the last 14 years.

Clinical trials

One example of successful results from GAP’s initiative was demonstrated in Kansas City, Missouri, US, with the programme Memory Strings Kansas City Alliance, which showed a 292% growth in the number of people contacting their local AD research centre to be enrolled into clinical trials after it was initiated, and also demonstrated a significant reduction in trial enrollment time, cutting it by half.

Furthermore, the GAP Foundation has established a GAP site network called GAP-Net, an integrated platform of 58 academic and private institutions that have been established as high-performance clinical trial sites. These sites conduct longitudinal studies and manage AD clinical studies with greater efficiency than clinical trial sites that are not part of GAP-Net. These collaborations, coupled with the new model, will speed up the AD clinical trials while protecting the rights and safety of the patients through the share of a single Institutional Review Board (IRB). IRB is an administrative body that reviews the methods proposed for research to ensure they are ethical, and has the main aim of assuring that the rights and welfare of the patients participating in the research studies are protected.

Despite the high failure rate in AD clinical trials and the high unmet needs for this disease, the initiatives of the GAP Foundation can facilitate the process of drug development for pharmaceutical companies that are attracted by the huge potential of the AD space. Although positive results of GAP’s approach were demonstrated in Kansas City, Missouri, US they are not enough to prove that the method is really effective. As such, GlobalData believes that more successful initiatives are needed to determine whether this approach should be adopted more widely.

Related Reports

GlobalData (2017). PharmaPoint: Alzheimer’s Disease – Global Drug Forecast and Market Analysis to 2026, August 2017, GDHC149PIDR