From The Editor | November 13, 2017

Can GAP Double The Number Of Patients In Alzheimer's Trials?

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader

Can GAP Double The Number Of Patients In Alzheimer’s Trials?

Curing diseases requires new drugs. Getting those new drugs approved by regulators requires data from successful clinical trials. Those trials depend on patients, and right now getting those patients is a challenge for many sponsor companies. According to research performed on recruitment, 85 percent of trials are delayed due to enrollment issues and more than 30 percent of total trial time is spent simply recruiting patients.

Those issues are present in all therapeutic areas, including Alzheimer’s disease. To mitigate these problems, cut the time of trials, and get needed medicines to patients faster, the Global Alzheimer’s Platform (GAP) Foundation is implementing a new model. The model promises to both accelerate clinical trials and increase patient participation in Alzheimer’s clinical research.

According to GAP, Alzheimer’s disease affects more than 5.4 million Americans and costs taxpayers more than $153 billion per year in Medicare and Medicaid expenses. By the year 2050, it’s estimated that 14 million Americans will be afflicted with the disease. With the aging population we currently have in this country, finding an effective treatment for the disease has never been more important.

Increase Trial Participation

The help advance a cure, GAP recently undertook an initiative dubbed the Memory Strings Kansas City Alliance. Results of that initiative showed an increase of 292 percent in the number of individuals contacting their local Alzheimer’s disease research center. The Kansas City Alliance also cut trial enrollment time in half. GAP has a goal of reducing trial cycle time by up to two years, with the hope of getting needed therapies to patients faster. GAP is convinced its methodology for expediting trials is working.

The GAP Foundation is currently pursuing a six-step process that will hopefully expedite trials and increase patient participation.

Recruitment: GAP is establishing a state-of-the-art online recruitment process for trial participants. The process will cover individuals ranging from pre-clinical and pre-symptomatic conditions to mild and moderate Alzheimer’s disease.

Expand High-Performing Sites: GAP is hoping to expand GAP-Net, an integrated platform of trial-ready, high-performing clinical trial sites. These sites are dedicated to shortening the duration of clinical trials. The network currently features 58 sites including Stanford University, University of California San Francisco, Compass Research, Raleigh Neurological Associates, University of Southern California, the Cleveland Clinic, Northwestern University, Emory University, the Mayo Clinic, Washington University, and Howard University.

Common IRB: Of the 58 sites included in GAP-Net, 47 academic and private sites all share the same Institutional Review Board (IRB). That makes GAP-Net the largest Alzheimer’s disease research network under a single IRB in the U.S. (and all of North America). That achievement alone allows GAP to deliver faster Alzheimer’s disease trial launches while also protecting the rights and safety of study participants.

Customized Recruitment: GAP is establishing a customized recruitment process that connects potential trial participants to GAP-Net research centers. The customized process also includes initiatives to increase community engagement, both live and online.

Increase Minority Participation: GAP is attempting to increase the level of clinical trial participation by Latino and African-American patients. It will do so by establishing relationships between GAP-Net sites and the healthcare professionals serving those patient populations.

A New Digital Platform: GAP is also launching, a digital platform that will connect GAP-Net researchers, research volunteers, caregivers, patient advocates, and local communities. The goal of the platform is to facilitate the inclusion of more Alzheimer’s patients into clinical trials.

New Approaches Reach Clinical Stage

The GAP news comes on the heels of a new report highlighting current innovation occurring in Alzheimer’s clinical trials. The report, Closing In On A Cure: 2017 Alzheimer’s Clinical Trials Report, notes there are currently 126 drugs in clinical development for those suffering from the effects of Alzheimer’s disease. The report was released by the Alzheimer’s Drug Discovery Foundation (ADDF).

While drugs targeting beta-amyloid remain the most prevalent, new drugs targeting inflammation, mitochondria, and neuroprotection are quickly gaining ground. The ADDF is funding these new approaches, and notes nearly 20 percent of the Alzheimer’s drugs now in clinical testing have received its support.

The report touches on other aspects of the current Alzheimer’s clinical pipeline, for instance:

  • There are a relatively small number of repurposed drugs being tested.
  • There has been a shift towards trials with earlier-stage patients.
  • Recruitment remains a persistent challenge with Alzheimer’s trials.
  • There is still a lack of validated biomarkers for innovative targets.
  • Half of the 126 Alzheimer’s treatments in clinical development are currently in Phase 2. Thirty-three are in Phase 1 while only 25 have made it to Phase 3 testing.
  • There are an additional 19 Drugs in clinical trials designated only to address symptoms experienced by Alzheimer’s patients. Those symptoms include agitation, depression, and insomnia.

GAP is a patient-centric, non-profit dedicated to speeding the delivery of innovative medicines to those in need by reducing the time and cost of Alzheimer’s disease clinical trials. Gap has formed a unique and growing network of 59 leading research centers across the U.S. and Canada to help optimize their operations.

ADDF was founded in 1998 and is the only philanthropy focused solely on accelerating the development of drugs to prevent and treat Alzheimer’s disease.