Background

  • 5.7 million Americans are afflicted with Alzheimer’s disease, and an additional, 16 million Americans actively support their care.
  • There are no disease modifying therapies available to treat Alzheimer’s. The last therapy approved for modestly addressing Alzheimer’s symptoms was in 2002.
  • One in three seniors die with Alzheimer’s or another dementia. It kills more than breast cancer and prostate cancer combined.
  • Today, another person develops the disease every 65 seconds; by 2050, someone in the United States will develop the disease every 33 seconds.
  • The cost of treating Alzheimer’s in the United States is estimated at $277 billion in 2018. Unabated by the introduction of effective disease deferring or disease modifying therapies, 14 million Americans will suffer from the disease and the cost of Alzheimer’s care will rise to $1.1 trillion in 2050, more than the current national defense budget.

(Source: Alzheimer’s Association Facts and Figures 2018)

Current Clinical Development Bottlenecks

A number of trials of at-risk older individuals thought to be in the preclinical or prodromal stages of AD are underway or currently being planned. The recruitment and site activation processes for these trials, however, face a number of challenges that create significant drug development bottlenecks. In the U.S., recent reviews show that 85-90% of trials have delayed recruitment, with 30% under-enrolling and only 7% of sites recruiting the projected number of participants. Factors contributing to these delays and shortfalls include:

  • Clinical trial infrastructure is rebuilt trial-by-trial, sponsor-by-sponsor.
  • AD trials require hundreds of global sites, which often vary in their quality of training, raters, data management, and imaging.
  • Participant recruitment and screen failure rates significantly increase trial costs and time.
  • No national or international institutional review boards (IRBs) exist.
  • Trials are often repeated multiple times at high costs

Reason to Hope

There are currently more than 100 promising AD therapies in clinical development. The goal of GAP is to greatly accelerate current and future secondary prevention trial enrollment through an innovative, highly efficient approach to identify, evaluate, and enroll appropriate preclinical and prodromal trial candidates. These efforts will be supported by a new infrastructure with distinct capacities needed for the successful operation of AD clinical trials.